Back Bay Cafe (21005), United States of America, Boston, Massachusetts Cafe Coach - Boston Metro Area Welcome to a new idea in banking. Here at Capital One, we're redefining how people bank. You see, we believe banking should fit our customers' everyday lives - not the other way around. Our Capital One Café is a welcoming environment where customers can try out our digital and financial tools, grab a great cup of coffee and get to know our Ambassadors (and each other). It's a place where they can recharge their mobile devices, plug into some free WiFi and learn new ways to save time and money. We're redefining the typical work experience, too. Our Café team exists to enhance the financial lives of people in the communities we serve. And we're not just looking to fill open positions - we seek outgoing, passionate people who love connecting, teaching and interacting with individuals and the community as a whole and really want to be a part of this whole reimagined banking experience. As the Café Coach, you'll have the unique role of leading a Café team and facilitating legendary experiences for our Customers. As the face of Capital One in the community, you'll build alliances with local organizations and collaborate with vendors to generate new business. You're more than just a manager for the Café Ambassador team, you'll be a trusted mentor and guide for their individual development and overall team performance. Don't just take our word for it, check out what our Café Ambassadors and Café Coaches have to say about their experience at Capital One, and learn more about working in our Cafés: Here's what we're looking for in you: - You're a mentor. You'll lead by example and help our Café Ambassadors develop professionally, personally, and as a high-performing team. - You're obsessed with the Café experience and bring our brand to life. You'll take pride in maintaining the physical space and coaching Café Ambassadors to create a welcoming environment for Café customers and visitors. - You're a forward thinker and drive continuous improvement. You never settle for the status quo. In fact, discovery drives you, and you're bringing everyone along for the ride. - You're a proven leader with a franchise ownership attitude. You've been there, done that as a manager of a team focused on achieving and exceeding customer-based goals and metrics. - You're friendly and engaging and can connect with Café visitors and regulars alike. Yep, you're a people person - whether you're handing out free coffee cards, helping folks with technology challenges or simply showing off some of the cool services and products we offer. - You're part of the community and have a deep understanding of your market. You'll work with local businesses, nonprofits and charities to plan events both in and outside of the Café. - You're naturally curious and like to learn. We'll teach you what Capital One has to offer our customers - products, services and experiences - to help steer them in the right direction toward their financial goals. - You're digitally savvy. You'll showcase what's possible in our physical space and how to easily navigate our mobile and online experience. - You're a customer advocate. You are always within reach when our customers need assistance. They rely on you to steer them in the right direction. You listen with patience and offer advice that's concise and easy to understand. - You're a team player. You'll work with an energized team of Café Ambassadors and help inspire your teammates as they inspire you If you're nodding along and like what you're reading, let's talk. Basic Qualifications: - High School Diploma, GED, or Equivalent Certification - At least 2 years of Customer, Retail, or Financial Services experience - At least 1 year of People Management experience or 2 years Retail Bank Experience Preferred Qualifications: - At least 3 years of Customer, Retail, or Financial Services experience - At least 2 years of People Management experience - Bachelor's Degree At this time, Capital One will not sponsor a new applicant for employment authorization for this position. Capital One offers a comprehensive, competitive, and inclusive set of health, financial and other benefits that support your total well-being. Learn more at the Capital One Careers website . Eligibility varies based on full or part-time status, exempt or non-exempt status, and management level. No agencies please. Capital One is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, physical and mental disability, genetic information, marital status, sexual orientation, gender identity/assignment, citizenship, pregnancy or maternity, protected veteran status, or any other status prohibited by applicable national, federal, state or local law. Capital One promotes a drug-free workplace. Capital One will consider for employment qualified applicants with a criminal history in a manner consistent with the requirements of applicable laws regarding criminal background inquiries, including, to the extent applicable, Article 23-A of the New York Correction Law; San Francisco, California Police Code Article 49, Sections ; New York City's Fair Chance Act; Philadelphia's Fair Criminal Records Screening Act; and other applicable federal, state, and local laws and regulations regarding criminal background inquiries. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation, please contact Capital One Recruiting at 1- or via email at . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations. For technical support or questions about Capital One's recruiting process, please send an email to Capital One does not provide, endorse nor guarantee and is not liable for third-party products, services, educational tools or other information available through this site. Capital One Financial is made up of several different entities. Please note that any position posted in Canada is for Capital One Canada, any position posted in the United Kingdom is for Capital One Europe and any position posted in the Philippines is for Capital One Philippines Service Corp. (COPSSC).
05/29/2023
Full time
Back Bay Cafe (21005), United States of America, Boston, Massachusetts Cafe Coach - Boston Metro Area Welcome to a new idea in banking. Here at Capital One, we're redefining how people bank. You see, we believe banking should fit our customers' everyday lives - not the other way around. Our Capital One Café is a welcoming environment where customers can try out our digital and financial tools, grab a great cup of coffee and get to know our Ambassadors (and each other). It's a place where they can recharge their mobile devices, plug into some free WiFi and learn new ways to save time and money. We're redefining the typical work experience, too. Our Café team exists to enhance the financial lives of people in the communities we serve. And we're not just looking to fill open positions - we seek outgoing, passionate people who love connecting, teaching and interacting with individuals and the community as a whole and really want to be a part of this whole reimagined banking experience. As the Café Coach, you'll have the unique role of leading a Café team and facilitating legendary experiences for our Customers. As the face of Capital One in the community, you'll build alliances with local organizations and collaborate with vendors to generate new business. You're more than just a manager for the Café Ambassador team, you'll be a trusted mentor and guide for their individual development and overall team performance. Don't just take our word for it, check out what our Café Ambassadors and Café Coaches have to say about their experience at Capital One, and learn more about working in our Cafés: Here's what we're looking for in you: - You're a mentor. You'll lead by example and help our Café Ambassadors develop professionally, personally, and as a high-performing team. - You're obsessed with the Café experience and bring our brand to life. You'll take pride in maintaining the physical space and coaching Café Ambassadors to create a welcoming environment for Café customers and visitors. - You're a forward thinker and drive continuous improvement. You never settle for the status quo. In fact, discovery drives you, and you're bringing everyone along for the ride. - You're a proven leader with a franchise ownership attitude. You've been there, done that as a manager of a team focused on achieving and exceeding customer-based goals and metrics. - You're friendly and engaging and can connect with Café visitors and regulars alike. Yep, you're a people person - whether you're handing out free coffee cards, helping folks with technology challenges or simply showing off some of the cool services and products we offer. - You're part of the community and have a deep understanding of your market. You'll work with local businesses, nonprofits and charities to plan events both in and outside of the Café. - You're naturally curious and like to learn. We'll teach you what Capital One has to offer our customers - products, services and experiences - to help steer them in the right direction toward their financial goals. - You're digitally savvy. You'll showcase what's possible in our physical space and how to easily navigate our mobile and online experience. - You're a customer advocate. You are always within reach when our customers need assistance. They rely on you to steer them in the right direction. You listen with patience and offer advice that's concise and easy to understand. - You're a team player. You'll work with an energized team of Café Ambassadors and help inspire your teammates as they inspire you If you're nodding along and like what you're reading, let's talk. Basic Qualifications: - High School Diploma, GED, or Equivalent Certification - At least 2 years of Customer, Retail, or Financial Services experience - At least 1 year of People Management experience or 2 years Retail Bank Experience Preferred Qualifications: - At least 3 years of Customer, Retail, or Financial Services experience - At least 2 years of People Management experience - Bachelor's Degree At this time, Capital One will not sponsor a new applicant for employment authorization for this position. Capital One offers a comprehensive, competitive, and inclusive set of health, financial and other benefits that support your total well-being. Learn more at the Capital One Careers website . Eligibility varies based on full or part-time status, exempt or non-exempt status, and management level. No agencies please. Capital One is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, physical and mental disability, genetic information, marital status, sexual orientation, gender identity/assignment, citizenship, pregnancy or maternity, protected veteran status, or any other status prohibited by applicable national, federal, state or local law. Capital One promotes a drug-free workplace. Capital One will consider for employment qualified applicants with a criminal history in a manner consistent with the requirements of applicable laws regarding criminal background inquiries, including, to the extent applicable, Article 23-A of the New York Correction Law; San Francisco, California Police Code Article 49, Sections ; New York City's Fair Chance Act; Philadelphia's Fair Criminal Records Screening Act; and other applicable federal, state, and local laws and regulations regarding criminal background inquiries. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation, please contact Capital One Recruiting at 1- or via email at . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations. For technical support or questions about Capital One's recruiting process, please send an email to Capital One does not provide, endorse nor guarantee and is not liable for third-party products, services, educational tools or other information available through this site. Capital One Financial is made up of several different entities. Please note that any position posted in Canada is for Capital One Canada, any position posted in the United Kingdom is for Capital One Europe and any position posted in the Philippines is for Capital One Philippines Service Corp. (COPSSC).
Who is BlueRock? BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives. This position is reports into the Vice President of Regulatory Affairs and Medical Writing. The incumbent is responsible for providing regulatory CMC leadership and guidance to regulatory strategy and CMC teams developing cell and gene therapy products, including generation of quality dossiers to support Health Authority meetings, INDs/CTAs/IMPDs, and marketing applications in the U.S. and multiple international territories. This role involves working closely with technical CMC teams, program teams, as well as sits on the Global Regulatory Strategy Subteam. Experience in neurology, ophthalmology and/or cardiovascular therapeutic areas and knowledge of global regulations for the development of cell therapy products is desired.Responsibilities:Represent regulatory CMC on and/or lead matrix teams for cell and gene therapy pipeline products.Independently provide strategic guidance/input related to current regulatory requirements and expectations for cell and gene therapy CMC in support of clinical trial and marketing applications.Independently manage and prioritize multiple complex projects.Drive workflows related to Health Agency interactions (ie, briefing documents and responses to questions).Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from departmental head on complex topics (ie, comparability, specification changes, etc.).Identify, communicate, and propose resolutions to routine and complex strategic issuesInterpret global regulations and guidance. Identify regulatory opportunities and risks. Anticipate and communicate possible regulatory paradigm shifts.Review and provide regulatory assessments on change controls.Prepare and manage CMC submissions for global markets while ensuring thoroughness, completeness, and timeliness, including creation and maintenance of strategy documentsMange relationships with diverse teams in a collaborative manner. Utilize electronic systems for dossier creation and tracking.Support departmental initiatives, including special projects, budgeting, and authoring departmental documentsMinimum Requirements:MS or PhD in sciences preferred but not required.The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.At least 8-10 years in Regulatory Affairs, CMC, and relevant years in a global pharmaceutical and/or biotechnology company with expertise in biologicals and/or cell and gene therapy products (preferred).Experience with combination products and device filing experience also preferred.Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA/IMPDs, and BLA/MAAs following eCTD format.Lead regulatory CMC discussions with global regulatory authorities.Experience in development, manufacturing and testing of cell therapeutics is highly desired.Experience in supporting the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments.Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand impacts on regulation.Strong interpersonal skills and the ability to collaborate effectively with various technical area experts including process development, manufacturing, Quality Assurance, Quality Control, non-clinical development, clinical development, and clinical operations.Excellent written and communication skills with attention to detail. Highly computer literate (Word, Excel PowerPoint), including formatting documents for regulatory submission.Ability to travel within US/Canada (and some additional, limited EU travel possible) up to 25% is required. BlueRock Therapeutics Company Culture HighlightsWinner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably. Check us out on Comparably: Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
05/29/2023
Full time
Who is BlueRock? BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives. This position is reports into the Vice President of Regulatory Affairs and Medical Writing. The incumbent is responsible for providing regulatory CMC leadership and guidance to regulatory strategy and CMC teams developing cell and gene therapy products, including generation of quality dossiers to support Health Authority meetings, INDs/CTAs/IMPDs, and marketing applications in the U.S. and multiple international territories. This role involves working closely with technical CMC teams, program teams, as well as sits on the Global Regulatory Strategy Subteam. Experience in neurology, ophthalmology and/or cardiovascular therapeutic areas and knowledge of global regulations for the development of cell therapy products is desired.Responsibilities:Represent regulatory CMC on and/or lead matrix teams for cell and gene therapy pipeline products.Independently provide strategic guidance/input related to current regulatory requirements and expectations for cell and gene therapy CMC in support of clinical trial and marketing applications.Independently manage and prioritize multiple complex projects.Drive workflows related to Health Agency interactions (ie, briefing documents and responses to questions).Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from departmental head on complex topics (ie, comparability, specification changes, etc.).Identify, communicate, and propose resolutions to routine and complex strategic issuesInterpret global regulations and guidance. Identify regulatory opportunities and risks. Anticipate and communicate possible regulatory paradigm shifts.Review and provide regulatory assessments on change controls.Prepare and manage CMC submissions for global markets while ensuring thoroughness, completeness, and timeliness, including creation and maintenance of strategy documentsMange relationships with diverse teams in a collaborative manner. Utilize electronic systems for dossier creation and tracking.Support departmental initiatives, including special projects, budgeting, and authoring departmental documentsMinimum Requirements:MS or PhD in sciences preferred but not required.The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.At least 8-10 years in Regulatory Affairs, CMC, and relevant years in a global pharmaceutical and/or biotechnology company with expertise in biologicals and/or cell and gene therapy products (preferred).Experience with combination products and device filing experience also preferred.Extensive experience in preparing quality sections of regulatory filings including health Authority briefing documents, IND/CTA/IMPDs, and BLA/MAAs following eCTD format.Lead regulatory CMC discussions with global regulatory authorities.Experience in development, manufacturing and testing of cell therapeutics is highly desired.Experience in supporting the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments.Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand impacts on regulation.Strong interpersonal skills and the ability to collaborate effectively with various technical area experts including process development, manufacturing, Quality Assurance, Quality Control, non-clinical development, clinical development, and clinical operations.Excellent written and communication skills with attention to detail. Highly computer literate (Word, Excel PowerPoint), including formatting documents for regulatory submission.Ability to travel within US/Canada (and some additional, limited EU travel possible) up to 25% is required. BlueRock Therapeutics Company Culture HighlightsWinner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably. Check us out on Comparably: Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Director, Commercial Regulatory Affairs Company: Ipsen Biopharmaceuticals Inc. Job Description: Director, Commercial Regulatory Affairs Position Summary The Director, Commercial Regulatory Affairs will report to the Sr. Director and have accountability for review and approval of promotional and medical communications of assigned brand(s). The Director is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made to OPDP/FDA. The incumbent's responsibility includes functioning as a leader during review meetings to assure compliance with and evolution of the Promotional Review Committee process enabling business needs to be met efficiently and effectively. Medical communications will be reviewed and approved at MRC in a similar process to PRC. This position requires frequent interaction and strong collaboration with Commercial Marketing, Medical Affairs, PRC/MRC Coordinators, Legal Affairs, Regulatory Affairs Strategy, Labeling Operations and Business Ethics for the purpose of providing regulatory advice and guidance during promotional plan development all the way through to field implementation assuring conformity with FDA requirements, PhRMA DTC Guidelines and Ipsen policies. Commercial regulatory is a solid partner with internal stakeholders providing proficient advice and practical solutions resulting in compliant communications about our products and disease areas of focus. As our portfolio expands so does our team. There is great opportunity for growth. Ipsen has global goal to fill 65% of leadership roles through internal promotion and has been named Best place to work in 75% of countries in which we operate. Ipsen culture is driven by desire to collaborate and excel for the benefits of patients and society. Our Ipsen Way of Being is a crucial success driver for our strategy and our colleagues are the hearts, brains and architects of Ipsen's success, now and in the future. Essential Functions Responsibilities Responsibilities will include, but are not limited to, the following: Serve as the internal subject matter expert on FDA Advertising & Promotion issues for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional materials to maintain compliance with FDA regulations Provide regulatory training as needed on FDA requirements, PhRMA DTC Guidelines and Company policy and leadership on assigned Promotional Review Committee(s) (PRC) with respect to best practices in compliance with company policies and guidelines for PRC processes. Demonstrate leadership as the regulatory reviewer on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate Develop SOPs and work instructions to facilitate stream-lined workflows and encourage proficient practice of process policy Liaise with OPDP/FDA as needed for assigned product(s) serving as our company's single point of contact with FDA on matters related to advertising and promotional materials. Manage interactions with OPDP/APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP/APLB staff Foster a business partnership environment grounded in trust and transparency between Regulatory and PRC partner functions in the review and approval of Ipsen product communications Collaborate with partner functions to share commercial regulatory guidance on US Commercial Teams' strategic imperatives Lead PRC teams in management of tasks that help support compliant execution of Marketing tactics and programs: implementing revised product labels in promotional materials, establishing life-cycle of content, appropriate balance and risk information and requisite training materials for reps Qualifications Education Minimum BS in scientific discipline Advanced scientific degree preferred, JD, MBA Experience Minimum of 10 years of experience in pharmaceutical industry and a minimum of 3-6 years in commercial regulatory affairs Experience in Rare Diseases, Neuroscience and/or Oncology a plus Expert knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling Solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters Oversee OPDP submissions and author all submissions for assigned products Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job) Ability to understand and interpret clinical trial data. Expert understanding of FDA promotional regulations, product and therapeutic knowledge as well as evidentiary standards required to support product claims Excellent oral and written communication and negotiation skills with strong attention to detail. Seasoned ability to spot issues and convey unique product facts, offering ideas and options as guidance to mitigate risks. Ability to articulate the impact to Ipsen associated with insufficient mitigation of risks. Ability to influence and interact effectively across relevant functions within Ipsen and with regulators. Demonstrate understanding of commercial objectives of the company and how outcomes can be delivered while meeting FDA compliance standards Be an innovator of new ideas and best practices Must anticipate and solve problems Recognized as a leader, team player, and possess a cross-functional collaborative skill set Ability to manage multiple activities or projects IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
05/29/2023
Full time
Title: Director, Commercial Regulatory Affairs Company: Ipsen Biopharmaceuticals Inc. Job Description: Director, Commercial Regulatory Affairs Position Summary The Director, Commercial Regulatory Affairs will report to the Sr. Director and have accountability for review and approval of promotional and medical communications of assigned brand(s). The Director is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made to OPDP/FDA. The incumbent's responsibility includes functioning as a leader during review meetings to assure compliance with and evolution of the Promotional Review Committee process enabling business needs to be met efficiently and effectively. Medical communications will be reviewed and approved at MRC in a similar process to PRC. This position requires frequent interaction and strong collaboration with Commercial Marketing, Medical Affairs, PRC/MRC Coordinators, Legal Affairs, Regulatory Affairs Strategy, Labeling Operations and Business Ethics for the purpose of providing regulatory advice and guidance during promotional plan development all the way through to field implementation assuring conformity with FDA requirements, PhRMA DTC Guidelines and Ipsen policies. Commercial regulatory is a solid partner with internal stakeholders providing proficient advice and practical solutions resulting in compliant communications about our products and disease areas of focus. As our portfolio expands so does our team. There is great opportunity for growth. Ipsen has global goal to fill 65% of leadership roles through internal promotion and has been named Best place to work in 75% of countries in which we operate. Ipsen culture is driven by desire to collaborate and excel for the benefits of patients and society. Our Ipsen Way of Being is a crucial success driver for our strategy and our colleagues are the hearts, brains and architects of Ipsen's success, now and in the future. Essential Functions Responsibilities Responsibilities will include, but are not limited to, the following: Serve as the internal subject matter expert on FDA Advertising & Promotion issues for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional materials to maintain compliance with FDA regulations Provide regulatory training as needed on FDA requirements, PhRMA DTC Guidelines and Company policy and leadership on assigned Promotional Review Committee(s) (PRC) with respect to best practices in compliance with company policies and guidelines for PRC processes. Demonstrate leadership as the regulatory reviewer on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate Develop SOPs and work instructions to facilitate stream-lined workflows and encourage proficient practice of process policy Liaise with OPDP/FDA as needed for assigned product(s) serving as our company's single point of contact with FDA on matters related to advertising and promotional materials. Manage interactions with OPDP/APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP/APLB staff Foster a business partnership environment grounded in trust and transparency between Regulatory and PRC partner functions in the review and approval of Ipsen product communications Collaborate with partner functions to share commercial regulatory guidance on US Commercial Teams' strategic imperatives Lead PRC teams in management of tasks that help support compliant execution of Marketing tactics and programs: implementing revised product labels in promotional materials, establishing life-cycle of content, appropriate balance and risk information and requisite training materials for reps Qualifications Education Minimum BS in scientific discipline Advanced scientific degree preferred, JD, MBA Experience Minimum of 10 years of experience in pharmaceutical industry and a minimum of 3-6 years in commercial regulatory affairs Experience in Rare Diseases, Neuroscience and/or Oncology a plus Expert knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling Solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters Oversee OPDP submissions and author all submissions for assigned products Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job) Ability to understand and interpret clinical trial data. Expert understanding of FDA promotional regulations, product and therapeutic knowledge as well as evidentiary standards required to support product claims Excellent oral and written communication and negotiation skills with strong attention to detail. Seasoned ability to spot issues and convey unique product facts, offering ideas and options as guidance to mitigate risks. Ability to articulate the impact to Ipsen associated with insufficient mitigation of risks. Ability to influence and interact effectively across relevant functions within Ipsen and with regulators. Demonstrate understanding of commercial objectives of the company and how outcomes can be delivered while meeting FDA compliance standards Be an innovator of new ideas and best practices Must anticipate and solve problems Recognized as a leader, team player, and possess a cross-functional collaborative skill set Ability to manage multiple activities or projects IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Description Evotec (US) Inc. has a Sample Management Lab Technician position open, located at a sample management operation in Cambridge, Massachusetts. The purpose of this position is to provide laboratory support for the processing of client orders. The laboratory technician processes, distributes and ships samples for testing and analysis. May setup and conduct tests, assays, and other protocols under the direction of a laboratory researcher or scientist. Follow Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLPs). Ensure all laboratory equipment and work areas are clean, sterile, and in proper working order. Will be responsible for calibration and operation of instruments and data information flow. Client site specific training, automation, computers and any other material will be provided in support of sample management activities. Duties and Responsibilities: Manage domestic and international shipment of chemical and biological samples between sites and collaborators Manual handling of incoming samples, including solubilisation, plating and powder weighing Coordinate order fulfilment using a global ordering system of both powders and solutions. Use liquid handling technology to fulfil orders and create final assay plates Manage data handling, inventory tracking, accurate record keeping and following Standard Operating Procedures for assigned tasks In depth knowledge of automated liquid handling processes and protocols Required Qualifications: Chemical Laboratory experience Use of balances, fume hoods, and basic chemical handling procedures Experience with automated liquid handling technology from vendors like Hamilton, Tecan, Agilent, Beckman DOT and IATA training (will be provided if needed) Good oral and written communications. Follow oral instructions and written protocols. Attention to detail, keep good records, works safely and to schedule. Education and experience: BS or equivalent with scientific disciple and 3-4 years' experience Evotec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
05/29/2023
Full time
Description Evotec (US) Inc. has a Sample Management Lab Technician position open, located at a sample management operation in Cambridge, Massachusetts. The purpose of this position is to provide laboratory support for the processing of client orders. The laboratory technician processes, distributes and ships samples for testing and analysis. May setup and conduct tests, assays, and other protocols under the direction of a laboratory researcher or scientist. Follow Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLPs). Ensure all laboratory equipment and work areas are clean, sterile, and in proper working order. Will be responsible for calibration and operation of instruments and data information flow. Client site specific training, automation, computers and any other material will be provided in support of sample management activities. Duties and Responsibilities: Manage domestic and international shipment of chemical and biological samples between sites and collaborators Manual handling of incoming samples, including solubilisation, plating and powder weighing Coordinate order fulfilment using a global ordering system of both powders and solutions. Use liquid handling technology to fulfil orders and create final assay plates Manage data handling, inventory tracking, accurate record keeping and following Standard Operating Procedures for assigned tasks In depth knowledge of automated liquid handling processes and protocols Required Qualifications: Chemical Laboratory experience Use of balances, fume hoods, and basic chemical handling procedures Experience with automated liquid handling technology from vendors like Hamilton, Tecan, Agilent, Beckman DOT and IATA training (will be provided if needed) Good oral and written communications. Follow oral instructions and written protocols. Attention to detail, keep good records, works safely and to schedule. Education and experience: BS or equivalent with scientific disciple and 3-4 years' experience Evotec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status. Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Medical Science Liaison, Oncology (OH & WV) Company: Ipsen Biopharmaceuticals Inc. Job Description: Medical Science Liaison - Oncology (OH & WV) Company Profile Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences, and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs. We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe, and Asia. As a growing organization, Ipsen North America is comprised of our United States and Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations. Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve. Position Summary The primary responsibility of the Oncology Medical Science Liaison is to serve as a field-base medical expert within Medical Affairs Organization and engage in mutual scientific exchange. Ipsen's Medical Field teams enhance the understanding of scientific and medical value of Ipsen's oncology/hematology products (marketed and pipeline) with Thought Leaders (TL) and Healthcare Providers (HCP) to further patient outcomes. MSL leverages deep scientific and business knowledge in life cycle management (LCM) and generate rich thought leader insights shared across the organization. MSL respond to customer inquiries to ensure focused and balanced clinical and scientific information that supports the appropriate use of Ipsen's products. MSL works with cross functional teams on business planning, special projects, and strategic development to support US Medical Affairs Medical Strategy. MSL adheres to internal standard processes and complies with regulatory and compliance requirements along with sustaining expertise in disease state management, emerging therapies, and the treatment landscape. Essential Functions Responsibilities Responsibilities of MSL include, but are not limited to the following: Demonstrate deep scientific expertise on Ipsen's Oncology/Hematology molecules/products, and therapeutic area to exchange relevant information and insights with thought leaders. Build, cultivate and maintain a focused group of regional thought leaders to ensure understanding of evolving healthcare trends across the relevant therapeutic area landscape. Respond to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Ipsen guidelines, policies & procedures. Represent Ipsen and US Medical Affairs Team during scientific conferences, continuing medical educational events, and medical meetings. Gather data and generates scientific insights from stakeholder interactions and provides feedback to the organization using appropriate mechanisms and tools. Recognize and capture scientific insights that deepen our understanding of the needs of thought leaders, healthcare providers, and patients to share with internal stakeholders. Respond to unsolicited requests regarding interest in investigator sponsored studies (ISS) and supports ISS submissions through appropriate internal processes. Assist with Company Sponsored Studies (CSS) from Phase I-IV, including investigator/site identification, site initiation visits and feedback regarding operational management to ensure optimal site selection and performance. Respond to unsolicited request for medical information associated with Ipsen products and disease state area. Train and facilitate speakers on Ipsen's products. Build and cultivate working relationships across internal stakeholders (Medical Affairs colleagues, Clinical Operations, HEOR, R&D, Medical Information and Commercial) while maintaining full compliance with relevant company, industry, legal and regulatory requirements. Work efficiently and balance all work to enhance performance and execute on local medical plan strategies within specified timelines. Participate on committees or project teams that support MSL strategies and tactics as delegated by MSL leadership. Engage in continuous independent learning within the therapeutic area and actively attend and participate in upskilling programs related to Ipsen molecules, products, disease states and relevant business topics. Qualifications Education Advanced Doctorate Degree required (MD, DO, PhD, PharmD, Nursing or equivalent) Experience Minimum 2 years Oncology MSL experience Minimum 3 years related work experience (clinical, managed care, or industry experience) Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job) Knowledge of oncology/hematology customer segments and market dynamics Demonstrated expertise in discussing scientific content and context to multiple audiences Experience with clinical research Excellent project management ability Excellent oral and written communication and interpersonal skills Thorough knowledge of regulatory environment Strong leadership capabilities Excellent collaboration skills Ability to travel (50-70%) based on size of geography The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state, or local law. Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
05/29/2023
Full time
Title: Medical Science Liaison, Oncology (OH & WV) Company: Ipsen Biopharmaceuticals Inc. Job Description: Medical Science Liaison - Oncology (OH & WV) Company Profile Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences, and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs. We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe, and Asia. As a growing organization, Ipsen North America is comprised of our United States and Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations. Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve. Position Summary The primary responsibility of the Oncology Medical Science Liaison is to serve as a field-base medical expert within Medical Affairs Organization and engage in mutual scientific exchange. Ipsen's Medical Field teams enhance the understanding of scientific and medical value of Ipsen's oncology/hematology products (marketed and pipeline) with Thought Leaders (TL) and Healthcare Providers (HCP) to further patient outcomes. MSL leverages deep scientific and business knowledge in life cycle management (LCM) and generate rich thought leader insights shared across the organization. MSL respond to customer inquiries to ensure focused and balanced clinical and scientific information that supports the appropriate use of Ipsen's products. MSL works with cross functional teams on business planning, special projects, and strategic development to support US Medical Affairs Medical Strategy. MSL adheres to internal standard processes and complies with regulatory and compliance requirements along with sustaining expertise in disease state management, emerging therapies, and the treatment landscape. Essential Functions Responsibilities Responsibilities of MSL include, but are not limited to the following: Demonstrate deep scientific expertise on Ipsen's Oncology/Hematology molecules/products, and therapeutic area to exchange relevant information and insights with thought leaders. Build, cultivate and maintain a focused group of regional thought leaders to ensure understanding of evolving healthcare trends across the relevant therapeutic area landscape. Respond to on and off-label questions with integrity, compliance, and adherence to legal, regulatory, and Ipsen guidelines, policies & procedures. Represent Ipsen and US Medical Affairs Team during scientific conferences, continuing medical educational events, and medical meetings. Gather data and generates scientific insights from stakeholder interactions and provides feedback to the organization using appropriate mechanisms and tools. Recognize and capture scientific insights that deepen our understanding of the needs of thought leaders, healthcare providers, and patients to share with internal stakeholders. Respond to unsolicited requests regarding interest in investigator sponsored studies (ISS) and supports ISS submissions through appropriate internal processes. Assist with Company Sponsored Studies (CSS) from Phase I-IV, including investigator/site identification, site initiation visits and feedback regarding operational management to ensure optimal site selection and performance. Respond to unsolicited request for medical information associated with Ipsen products and disease state area. Train and facilitate speakers on Ipsen's products. Build and cultivate working relationships across internal stakeholders (Medical Affairs colleagues, Clinical Operations, HEOR, R&D, Medical Information and Commercial) while maintaining full compliance with relevant company, industry, legal and regulatory requirements. Work efficiently and balance all work to enhance performance and execute on local medical plan strategies within specified timelines. Participate on committees or project teams that support MSL strategies and tactics as delegated by MSL leadership. Engage in continuous independent learning within the therapeutic area and actively attend and participate in upskilling programs related to Ipsen molecules, products, disease states and relevant business topics. Qualifications Education Advanced Doctorate Degree required (MD, DO, PhD, PharmD, Nursing or equivalent) Experience Minimum 2 years Oncology MSL experience Minimum 3 years related work experience (clinical, managed care, or industry experience) Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job) Knowledge of oncology/hematology customer segments and market dynamics Demonstrated expertise in discussing scientific content and context to multiple audiences Experience with clinical research Excellent project management ability Excellent oral and written communication and interpersonal skills Thorough knowledge of regulatory environment Strong leadership capabilities Excellent collaboration skills Ability to travel (50-70%) based on size of geography The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state, or local law. Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: . Position Responsibilities The Associate Director, Regulatory Affairs will develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC. Lead global and/or regional regulatory team on assigned projects. Develop and execute US regulatory strategy and contingencies for assigned projects. Serve as the primary interface for FDA on assigned projects. Lead the preparation of submissions, which may include INDs Briefing Documents, Orphan Drug Applications, and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for assigned projects. Prepare company team for FDA and other health agency meetings, as required. Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures. Degree/Experience Requirements Ph.D., M.D., PharmD., MS or commensurate experience. Significant experience in regulatory affairs (e.g. 3-5 years) Experience in multiple phases of development in various therapeutic areas. Experience in inflammatory and immune diseases is a plus. Thorough knowledge of the drug development process, IND and NDA process. Demonstrated experience in preparing FDA submissions. Inter-dependant partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment. Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. Must be able to innovate, analyze and solve critical problems with minimal supervision and attention to detail. Domestic and occasional international travel may be necessary. The starting compensation for this job is a range from $141,000-$200,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed. Final individual compensation will be decided based on demonstrated experience. For more on benefits, please visit our Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
05/28/2023
Full time
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: . Position Responsibilities The Associate Director, Regulatory Affairs will develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC. Lead global and/or regional regulatory team on assigned projects. Develop and execute US regulatory strategy and contingencies for assigned projects. Serve as the primary interface for FDA on assigned projects. Lead the preparation of submissions, which may include INDs Briefing Documents, Orphan Drug Applications, and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for assigned projects. Prepare company team for FDA and other health agency meetings, as required. Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures. Degree/Experience Requirements Ph.D., M.D., PharmD., MS or commensurate experience. Significant experience in regulatory affairs (e.g. 3-5 years) Experience in multiple phases of development in various therapeutic areas. Experience in inflammatory and immune diseases is a plus. Thorough knowledge of the drug development process, IND and NDA process. Demonstrated experience in preparing FDA submissions. Inter-dependant partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment. Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. Must be able to innovate, analyze and solve critical problems with minimal supervision and attention to detail. Domestic and occasional international travel may be necessary. The starting compensation for this job is a range from $141,000-$200,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed. Final individual compensation will be decided based on demonstrated experience. For more on benefits, please visit our Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location. If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Reference No. R Position Title: Product Owner (Digital Data, Large Molecule Research) Department: Data Strategy Program At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. As one of Canada's leading investors in life sciences, manufacturing and research and development, we focus on delivering new and better ways to address unmet medical needs. Our life-changing and lifesaving products are grounded in science that Canadians can trust. They empower self-care, prevent and treat diseases, and help people live better. Location: Located in the downtown area of Toronto, Ontario Canada, our team uses a hybrid working model combining remote and office-based work. The Digital Team at Sanofi is a unique data-driven team. We pride ourselves on being data obsessed and highly focused on using state of the art processes along with global technologies to drive impact to our solutions. We measure our insights and products based on how they perform across the globe and hold ourselves to the highest regard as our solutions can impact millions of lives. When tackling a problem, we do not just ask how we will create a solution, but how we will create a solution that reaches across the world with the best possible societal outcome. If you are passionate about improving the health and wellness of people across the globe using Data as your means, then you should look no farther than the Digital Team here at Sanofi. Join us on our journey in enabling Sanofi's Digital Transformation through becoming an AI first organization. AI Factory - Versatile Teams Operating in Cross Functional Pods: Utilizing digital and data resources to develop AI products, bringing data management, AI and product development skills to products, programs and projects to create an agile, fulfilling and meaningful work environment. Leading Edge Tech Stack: Experience build products that will be deployed globally on a leading-edge tech stack. World Class Mentorship and Training: Working with renowned, published leaders and academics in machine learning to further develop your skillsets. Our vision for digital, data analytics and AI Sanofi has embarked into a vast and ambitious digital transformation program. A cornerstone of this roadmap is the acceleration of its data transformation and of the adoption of artificial intelligence (AI) and machine learning (ML) solutions. This has enabled us, to accelerate R&D, improve manufacturing and commercial performance, and bring novel drugs and vaccines to patients faster, all in order to improve health and save lives. Product Owner (Digital Data - Large Molecule Research) Sanofi has recently embarked on a vast and ambitious digital transformation program. A cornerstone of this roadmap is the acceleration of its data transformation and of the adoption of artificial intelligence (AI) and machine learning (ML) solutions to accelerate R&D, manufacturing and commercial performance, and bring better drugs and vaccines to patients faster, to improve health and save lives. In alignment to our digital transformation, we have launched a new major strategic initiative in 2023: the Biologics x AI Transformation. This is positioned to be a unique data-driven team, with expertise in AI platforms, data engineering, ML operations, data science, computational biology, strategy, and beyond. We are working as one to identify, design, and scale state-of-the-art AI capabilities targeted to truly transform how we research biologics. Who You Are: You are a n experienced Product Manager / Owner with a passion for building data centric software products in an agile way. You are passionate about working with cross-functional teams of data scientists, engineers and business analysts to build and deliver exceptional data products relying on data foundations, advanced data science capabilities, and /or compelling visualizations to make a difference for the patients of tomorrow. You are comfortable guiding technical implementation decisions drawing from various perspectives, benefits, dependencies and engineering commitments to create a comprehensive roadmap. You enjoy defining and guiding implementation of KPIs to ensure design and delivery of extraordinary applications. Key Responsibilities: Owns the Why, What and When of the product : responsible for the product vision and roadmap in alignment with broader organization goals. Connects business and tech worlds. Owns the user experience - internal v oice of the user in the pod (product team) , supported by UX/CX. Works with the sc r um master and the digital data team daily , maintaining team health. Owns the product backlog and its continuous refinement and prioritization. Negotiates Yes/No with the business and with the delivery team ; empowered to make decisions related to product features, backlog prioritization, release planning. Defines user stories and accepts them from the delivery team. Measures generated value and incorporate s user feedbacks to ensure continuous value delivery. Ensures good practices in architecture and that the product meets applicable quality, regulatory (Data Privacy, GxP , SOX, etc.) and cybersecurity requirements. Develop launch plans, ensure readiness of the various cross-functional partners. Provide consistent updates to leadership and executives, making communication easy and clear regarding product issues and decisions to be made. Lead business-critical operational performance indicators and technical metrics. Key Requirements: Ability to connect tech and business worlds. Business acumen. Ability to prioritize among conflicting priorities and requests in a complex, multinational environment. Data-driven - product analytics matter! Excellent communication skills. Curiosity, asking the "Why" questions from the business to understand business rules better and the "How" questions from the development team to create a better vision of what the final product should be. Proven experience with Agile practices and expectations. Strong communication skills, both written and verbal. Creativity to go beyond current processes to deliver the best solution for a problem or opportunity. Experience guiding large-scale, data-centric software products. Experience leading multi-department teams: clarifying requirements, resolving conflicts, defining roadmap and driving progress. Specific domain expertise may be required for some roles ( e.g. experience in the life sciences industry, knowledge in B2C or B2B marketing /commercial analytics, web development, etc.). Agile / Scrum practices using Atlassian software (Jira, Confluence). User Experience. Deep understanding on data engineering and/or modern visual analytics; Prior experience with data science/ AI/ML desirable. Knowledge and experience working with modern cloud- based systems (AWS preferred). Some specific experience may be required for products involving machine learning models , descriptive analytics (BI solution e.g. Power BI), user-facing web /mobile apps , data platforms (Snowflake/Informatica) , or cloud platforms (AWS) . For d ata products involving d ata s cience: deep functional understanding of machine learning algorithms. Pursue Progress . Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at ! Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Follow Sanofi on and on LinkedIn: At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
05/28/2023
Full time
Reference No. R Position Title: Product Owner (Digital Data, Large Molecule Research) Department: Data Strategy Program At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. As one of Canada's leading investors in life sciences, manufacturing and research and development, we focus on delivering new and better ways to address unmet medical needs. Our life-changing and lifesaving products are grounded in science that Canadians can trust. They empower self-care, prevent and treat diseases, and help people live better. Location: Located in the downtown area of Toronto, Ontario Canada, our team uses a hybrid working model combining remote and office-based work. The Digital Team at Sanofi is a unique data-driven team. We pride ourselves on being data obsessed and highly focused on using state of the art processes along with global technologies to drive impact to our solutions. We measure our insights and products based on how they perform across the globe and hold ourselves to the highest regard as our solutions can impact millions of lives. When tackling a problem, we do not just ask how we will create a solution, but how we will create a solution that reaches across the world with the best possible societal outcome. If you are passionate about improving the health and wellness of people across the globe using Data as your means, then you should look no farther than the Digital Team here at Sanofi. Join us on our journey in enabling Sanofi's Digital Transformation through becoming an AI first organization. AI Factory - Versatile Teams Operating in Cross Functional Pods: Utilizing digital and data resources to develop AI products, bringing data management, AI and product development skills to products, programs and projects to create an agile, fulfilling and meaningful work environment. Leading Edge Tech Stack: Experience build products that will be deployed globally on a leading-edge tech stack. World Class Mentorship and Training: Working with renowned, published leaders and academics in machine learning to further develop your skillsets. Our vision for digital, data analytics and AI Sanofi has embarked into a vast and ambitious digital transformation program. A cornerstone of this roadmap is the acceleration of its data transformation and of the adoption of artificial intelligence (AI) and machine learning (ML) solutions. This has enabled us, to accelerate R&D, improve manufacturing and commercial performance, and bring novel drugs and vaccines to patients faster, all in order to improve health and save lives. Product Owner (Digital Data - Large Molecule Research) Sanofi has recently embarked on a vast and ambitious digital transformation program. A cornerstone of this roadmap is the acceleration of its data transformation and of the adoption of artificial intelligence (AI) and machine learning (ML) solutions to accelerate R&D, manufacturing and commercial performance, and bring better drugs and vaccines to patients faster, to improve health and save lives. In alignment to our digital transformation, we have launched a new major strategic initiative in 2023: the Biologics x AI Transformation. This is positioned to be a unique data-driven team, with expertise in AI platforms, data engineering, ML operations, data science, computational biology, strategy, and beyond. We are working as one to identify, design, and scale state-of-the-art AI capabilities targeted to truly transform how we research biologics. Who You Are: You are a n experienced Product Manager / Owner with a passion for building data centric software products in an agile way. You are passionate about working with cross-functional teams of data scientists, engineers and business analysts to build and deliver exceptional data products relying on data foundations, advanced data science capabilities, and /or compelling visualizations to make a difference for the patients of tomorrow. You are comfortable guiding technical implementation decisions drawing from various perspectives, benefits, dependencies and engineering commitments to create a comprehensive roadmap. You enjoy defining and guiding implementation of KPIs to ensure design and delivery of extraordinary applications. Key Responsibilities: Owns the Why, What and When of the product : responsible for the product vision and roadmap in alignment with broader organization goals. Connects business and tech worlds. Owns the user experience - internal v oice of the user in the pod (product team) , supported by UX/CX. Works with the sc r um master and the digital data team daily , maintaining team health. Owns the product backlog and its continuous refinement and prioritization. Negotiates Yes/No with the business and with the delivery team ; empowered to make decisions related to product features, backlog prioritization, release planning. Defines user stories and accepts them from the delivery team. Measures generated value and incorporate s user feedbacks to ensure continuous value delivery. Ensures good practices in architecture and that the product meets applicable quality, regulatory (Data Privacy, GxP , SOX, etc.) and cybersecurity requirements. Develop launch plans, ensure readiness of the various cross-functional partners. Provide consistent updates to leadership and executives, making communication easy and clear regarding product issues and decisions to be made. Lead business-critical operational performance indicators and technical metrics. Key Requirements: Ability to connect tech and business worlds. Business acumen. Ability to prioritize among conflicting priorities and requests in a complex, multinational environment. Data-driven - product analytics matter! Excellent communication skills. Curiosity, asking the "Why" questions from the business to understand business rules better and the "How" questions from the development team to create a better vision of what the final product should be. Proven experience with Agile practices and expectations. Strong communication skills, both written and verbal. Creativity to go beyond current processes to deliver the best solution for a problem or opportunity. Experience guiding large-scale, data-centric software products. Experience leading multi-department teams: clarifying requirements, resolving conflicts, defining roadmap and driving progress. Specific domain expertise may be required for some roles ( e.g. experience in the life sciences industry, knowledge in B2C or B2B marketing /commercial analytics, web development, etc.). Agile / Scrum practices using Atlassian software (Jira, Confluence). User Experience. Deep understanding on data engineering and/or modern visual analytics; Prior experience with data science/ AI/ML desirable. Knowledge and experience working with modern cloud- based systems (AWS preferred). Some specific experience may be required for products involving machine learning models , descriptive analytics (BI solution e.g. Power BI), user-facing web /mobile apps , data platforms (Snowflake/Informatica) , or cloud platforms (AWS) . For d ata products involving d ata s cience: deep functional understanding of machine learning algorithms. Pursue Progress . Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at ! Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. Thank you in advance for your interest. Only those candidates selected for interviews will be contacted. Follow Sanofi on and on LinkedIn: At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
At EF Ultimate Break, we give anyone 18-35 an opportunity to transition from tourist to traveler. We do more than help people get a stamp in their passport, our guided tours encourage them to step outside their comfort zone, create forever friendships, immerse themselves in unfamiliar places, expand their mind through new cultures and come home with a changed perspective of the world. WARNING: working at Ultimate Break, may inspire your own desire to see the world, good news is- we'll help with that. We are currently seeking a highly skilled and experienced Paid Media Manager to join our growing acquisition team. The ideal candidate will be responsible for managing and optimizing our Google Paid Search and YouTube Ad accounts, as well as playing a significant role in reporting and analysis of our campaigns' performance across all media channels. Key Responsibilities: Develop, implement, and manage paid media campaigns on Google Ads and YouTube, focusing on driving conversions and increasing ROI. Conduct keyword research, write compelling ad copy, and optimize ad creative for maximum engagement. Monitor, track, and analyze campaign performance using Google Analytics, Google Ads, and Tableau. Provide comprehensive reporting on key campaign KPIs and make data-driven recommendations for continuous improvement. Collaborate with cross-functional teams, including marketing, creative, and market development to ensure consistent messaging and branding across marketing channels. Stay up to date with industry trends and best practices in paid media, including Google Ads and YouTube advertising, to maximize campaign performance. Manage budgets and bids, ensuring campaigns are optimized for cost efficiency and target audience reach. Identify and leverage new advertising opportunities within Google and YouTube to drive incremental growth. Develop and maintain strong relationships with Google representatives to receive platform updates and stay informed on new features and best practices. Qualifications: Bachelor's degree in Marketing, Advertising, Computer Science, Math, or a related field. 2+ years of experience managing Google Ads and YouTube advertising campaigns, preferably in the B2C space. Google Ads and Google Analytics certifications are highly preferred. Strong analytical skills and proficiency in Google Analytics, Google Ads, Excel, and other reporting tools. Excellent written and verbal communication skills with a strong attention to detail. Proven track record of managing successful campaigns with quantifiable results. Demonstrated ability to manage multiple projects and priorities in a fast-paced environment. Strong problem-solving skills and a creative approach to overcoming challenges. Why you'll love working here: Work in our beautiful Cambridge office where you'll enjoy comprehensive professional development, frequent social programming and employee-run social groups (including our "EFinity"groups: and You can expect: Eligibility for our Workplace Flexibility Program: our pilot hybrid work model with up to two days of work-from-home per week, after your initial onboarding Robust professional growth opportunities including monthly trainings, workshops, and inspiring talks with global leaders and experts Four weeks paid vacation your first year and ten paid holidays 25% company match on your 401(k) contributions Excellent medical, dental, and vision coverage, along with life and disability insurance Paid international business travel Wellness benefits and a yearly fitness reimbursement EF program discounts including travel, language schools, childcare, and more Dependent care, healthcare, and commuter flexible spending accounts (FSAs) Discounts at local venues and businesses About EF Education First: At EF we believe that the world is better when people try to understand one another. Since 1965, we have helped millions of people see new places, experience new cultures, and learn new things about the world and about themselves. Our culturally immersive education programs-focused on language, travel, cultural exchange, and academics-turn dreams into international opportunities. When you join EF, you join a multicultural and diverse community working across more than 600 schools and offices in 50 countries, all with one shared mission of opening the world through education. Whoever you are, whatever you are passionate about-we welcome you and want you to bring that to work every day. EF is proud to be an equal opportunity employer and we are committed to inclusion and belonging across race, ethnicity, gender, age, religion, identity, parental status, experience and everything else that makes you unique. Founded in Sweden in 1965, EF has schools and offices around the world, including hubs in Boston, London, Mexico City, São Paulo, Shanghai, Stockholm, Zürich, and more. Learn more at .
05/27/2023
Full time
At EF Ultimate Break, we give anyone 18-35 an opportunity to transition from tourist to traveler. We do more than help people get a stamp in their passport, our guided tours encourage them to step outside their comfort zone, create forever friendships, immerse themselves in unfamiliar places, expand their mind through new cultures and come home with a changed perspective of the world. WARNING: working at Ultimate Break, may inspire your own desire to see the world, good news is- we'll help with that. We are currently seeking a highly skilled and experienced Paid Media Manager to join our growing acquisition team. The ideal candidate will be responsible for managing and optimizing our Google Paid Search and YouTube Ad accounts, as well as playing a significant role in reporting and analysis of our campaigns' performance across all media channels. Key Responsibilities: Develop, implement, and manage paid media campaigns on Google Ads and YouTube, focusing on driving conversions and increasing ROI. Conduct keyword research, write compelling ad copy, and optimize ad creative for maximum engagement. Monitor, track, and analyze campaign performance using Google Analytics, Google Ads, and Tableau. Provide comprehensive reporting on key campaign KPIs and make data-driven recommendations for continuous improvement. Collaborate with cross-functional teams, including marketing, creative, and market development to ensure consistent messaging and branding across marketing channels. Stay up to date with industry trends and best practices in paid media, including Google Ads and YouTube advertising, to maximize campaign performance. Manage budgets and bids, ensuring campaigns are optimized for cost efficiency and target audience reach. Identify and leverage new advertising opportunities within Google and YouTube to drive incremental growth. Develop and maintain strong relationships with Google representatives to receive platform updates and stay informed on new features and best practices. Qualifications: Bachelor's degree in Marketing, Advertising, Computer Science, Math, or a related field. 2+ years of experience managing Google Ads and YouTube advertising campaigns, preferably in the B2C space. Google Ads and Google Analytics certifications are highly preferred. Strong analytical skills and proficiency in Google Analytics, Google Ads, Excel, and other reporting tools. Excellent written and verbal communication skills with a strong attention to detail. Proven track record of managing successful campaigns with quantifiable results. Demonstrated ability to manage multiple projects and priorities in a fast-paced environment. Strong problem-solving skills and a creative approach to overcoming challenges. Why you'll love working here: Work in our beautiful Cambridge office where you'll enjoy comprehensive professional development, frequent social programming and employee-run social groups (including our "EFinity"groups: and You can expect: Eligibility for our Workplace Flexibility Program: our pilot hybrid work model with up to two days of work-from-home per week, after your initial onboarding Robust professional growth opportunities including monthly trainings, workshops, and inspiring talks with global leaders and experts Four weeks paid vacation your first year and ten paid holidays 25% company match on your 401(k) contributions Excellent medical, dental, and vision coverage, along with life and disability insurance Paid international business travel Wellness benefits and a yearly fitness reimbursement EF program discounts including travel, language schools, childcare, and more Dependent care, healthcare, and commuter flexible spending accounts (FSAs) Discounts at local venues and businesses About EF Education First: At EF we believe that the world is better when people try to understand one another. Since 1965, we have helped millions of people see new places, experience new cultures, and learn new things about the world and about themselves. Our culturally immersive education programs-focused on language, travel, cultural exchange, and academics-turn dreams into international opportunities. When you join EF, you join a multicultural and diverse community working across more than 600 schools and offices in 50 countries, all with one shared mission of opening the world through education. Whoever you are, whatever you are passionate about-we welcome you and want you to bring that to work every day. EF is proud to be an equal opportunity employer and we are committed to inclusion and belonging across race, ethnicity, gender, age, religion, identity, parental status, experience and everything else that makes you unique. Founded in Sweden in 1965, EF has schools and offices around the world, including hubs in Boston, London, Mexico City, São Paulo, Shanghai, Stockholm, Zürich, and more. Learn more at .
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: Director/Senior Director, Global Regulatory Affairs Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director/Senior Director, Global Regulatory Affairs in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director/Senior Director, Global Regulatory Affairs working on the Global Regulatory Affairs team, you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects, and a typical day will include: Objectives: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director/Sr. Director will be responsible for overseeing an assigned portfolio of projects or highly complex projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director/Sr. Director will lead all submission types. Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct reports as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. LOCATION: The role can be hybrid or at our Cambridge, MA office In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
05/27/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: Director/Senior Director, Global Regulatory Affairs Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director/Senior Director, Global Regulatory Affairs in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director/Senior Director, Global Regulatory Affairs working on the Global Regulatory Affairs team, you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects, and a typical day will include: Objectives: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director/Sr. Director will be responsible for overseeing an assigned portfolio of projects or highly complex projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director/Sr. Director will lead all submission types. Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct reports as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. LOCATION: The role can be hybrid or at our Cambridge, MA office In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: Director/Senior Director, Global Regulatory Affairs Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director/Senior Director, Global Regulatory Affairs in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director/Senior Director, Global Regulatory Affairs working on the Global Regulatory Affairs team, you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects, and a typical day will include: Objectives: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director/Sr. Director will be responsible for overseeing an assigned portfolio of projects or highly complex projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director/Sr. Director will lead all submission types. Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct reports as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. LOCATION: The role can be hybrid or at our Cambridge, MA office In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
05/27/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: Director/Senior Director, Global Regulatory Affairs Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director/Senior Director, Global Regulatory Affairs in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director/Senior Director, Global Regulatory Affairs working on the Global Regulatory Affairs team, you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects, and a typical day will include: Objectives: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director/Sr. Director will be responsible for overseeing an assigned portfolio of projects or highly complex projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director/Sr. Director will lead all submission types. Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct reports as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. LOCATION: The role can be hybrid or at our Cambridge, MA office In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
Maintenance Technician - Cambridge Commons ($3,000 Sign-on Bonus) Location: Cambridge, MD Time Type: Full time Posted Date: Posted 13 Days Ago Requisition ID: REQ2000 Enterprise is a national nonprofit that exists to make a good home possible for the millions of families without one. We support community development organizations on the ground, aggregate and invest capital for impact, advance housing policy at every level of government, and build and manage communities ourselves. Since 1982, we have invested $54 billion and created 873,000 homes across all 50 states - all to make home and community places of pride, power and belonging. Join us at enterprisecommunity.org. Working at Enterprise At Enterprise, you'll be part of a diverse, committed team making a difference every day. You will collaborate with some of the smartest minds and biggest hearts in our field. You'll be empowered to drive systems change and take bold steps to advance racial equity. And you will find a career home where you're valued and supported in your growth journey. Enterprise offers career opportunities in our offices across the country with an exceptional benefits package . Job Description Summary: Responsible for various day-to-day service needs with regards to the physical condition, appearance and operational efficiency of the property, ensuring a safe and attractive living environment for residents, exceptional quality and service, and sustained resident satisfaction. Job Responsibilities: Consistently and genuinely demonstrate the HEROES principles of HELPFUL, ENGAGED, RESPONSIVE, OUTSTANDING, EXCELLENCE and SUCCESS in all activities and interactions. Ensures timely, accurate, and high-quality completion of resident service requests. Performs a variety of routine, preventive, scheduled, and emergency maintenance repairs, as well as general upkeep tasks throughout the community and on all equipment; maintains appropriate logs and records. Contributes to marketing efforts and resident satisfaction by providing excellent customer service; communicates effectively, appropriately, and courteously with residents, associates, management and guests to ensure that all areas of concern are addressed promptly and professionally. Participates in apartment turnovers as directed. Repairs, renovates, paints, and cleans vacant apartments. Ensures that all areas are kept safe, tidy and free of trash, debris and animal waste, including the cleanliness of the dumpster areas, as well as the necessary preparation of dumpsters for trash pick-up. Continuously monitors all areas of the community and grounds to ensure they are properly and safely maintained; advises management of any areas needing attention. Maintains landscaping including watering of the flowers; performs snow removal as needed. Provides guidance, direction and training to Maintenance Apprentices & Porters. Complies with all policies and procedures and external regulatory requirements; ensures solid understanding of all operational and human resources policies and procedures. Responds timely, appropriately and courteously to emergencies. Participates in and attends all required in-service training sessions. Supports other communities as assigned by management. Other duties as assigned. Supervisory Responsibilities: This position has no supervisory responsibilities. Qualifications: High School Diploma or G.E.D. Basic skill in areas such as carpentry, plumbing, electrical, HVAC, equipment repair, and painting. EPA Section 608 Technician Certification- Type II or Universal Certification (or ability to obtain within 90 days of employment). Ability to demonstrate proficiency in the use of hand and power tools. Ability to work in a fast paced environment demonstrating strong organizational and follow up skills along with an ability to manage multiple priorities. Strong verbal and written communication skills with the ability to interact, in English, with a diverse group of associates, residents and external agencies. Ability to read, in English, at a level sufficient to understand policies and procedures, safety notices, general business correspondence and/or documentation. Excellent interpersonal skills. Positive attitude, enthusiasm and energy. Strong customer service orientation to older adults. Strong attention to detail. Proficiency with basic computer keyboarding and navigational skills. Requirements: Provide basic tool set. Possess and maintain timely and reliable transportation. When on-call, be ready, available, fit for work, and able to report to the property within 30 minutes of receiving a call. PI
05/27/2023
Full time
Maintenance Technician - Cambridge Commons ($3,000 Sign-on Bonus) Location: Cambridge, MD Time Type: Full time Posted Date: Posted 13 Days Ago Requisition ID: REQ2000 Enterprise is a national nonprofit that exists to make a good home possible for the millions of families without one. We support community development organizations on the ground, aggregate and invest capital for impact, advance housing policy at every level of government, and build and manage communities ourselves. Since 1982, we have invested $54 billion and created 873,000 homes across all 50 states - all to make home and community places of pride, power and belonging. Join us at enterprisecommunity.org. Working at Enterprise At Enterprise, you'll be part of a diverse, committed team making a difference every day. You will collaborate with some of the smartest minds and biggest hearts in our field. You'll be empowered to drive systems change and take bold steps to advance racial equity. And you will find a career home where you're valued and supported in your growth journey. Enterprise offers career opportunities in our offices across the country with an exceptional benefits package . Job Description Summary: Responsible for various day-to-day service needs with regards to the physical condition, appearance and operational efficiency of the property, ensuring a safe and attractive living environment for residents, exceptional quality and service, and sustained resident satisfaction. Job Responsibilities: Consistently and genuinely demonstrate the HEROES principles of HELPFUL, ENGAGED, RESPONSIVE, OUTSTANDING, EXCELLENCE and SUCCESS in all activities and interactions. Ensures timely, accurate, and high-quality completion of resident service requests. Performs a variety of routine, preventive, scheduled, and emergency maintenance repairs, as well as general upkeep tasks throughout the community and on all equipment; maintains appropriate logs and records. Contributes to marketing efforts and resident satisfaction by providing excellent customer service; communicates effectively, appropriately, and courteously with residents, associates, management and guests to ensure that all areas of concern are addressed promptly and professionally. Participates in apartment turnovers as directed. Repairs, renovates, paints, and cleans vacant apartments. Ensures that all areas are kept safe, tidy and free of trash, debris and animal waste, including the cleanliness of the dumpster areas, as well as the necessary preparation of dumpsters for trash pick-up. Continuously monitors all areas of the community and grounds to ensure they are properly and safely maintained; advises management of any areas needing attention. Maintains landscaping including watering of the flowers; performs snow removal as needed. Provides guidance, direction and training to Maintenance Apprentices & Porters. Complies with all policies and procedures and external regulatory requirements; ensures solid understanding of all operational and human resources policies and procedures. Responds timely, appropriately and courteously to emergencies. Participates in and attends all required in-service training sessions. Supports other communities as assigned by management. Other duties as assigned. Supervisory Responsibilities: This position has no supervisory responsibilities. Qualifications: High School Diploma or G.E.D. Basic skill in areas such as carpentry, plumbing, electrical, HVAC, equipment repair, and painting. EPA Section 608 Technician Certification- Type II or Universal Certification (or ability to obtain within 90 days of employment). Ability to demonstrate proficiency in the use of hand and power tools. Ability to work in a fast paced environment demonstrating strong organizational and follow up skills along with an ability to manage multiple priorities. Strong verbal and written communication skills with the ability to interact, in English, with a diverse group of associates, residents and external agencies. Ability to read, in English, at a level sufficient to understand policies and procedures, safety notices, general business correspondence and/or documentation. Excellent interpersonal skills. Positive attitude, enthusiasm and energy. Strong customer service orientation to older adults. Strong attention to detail. Proficiency with basic computer keyboarding and navigational skills. Requirements: Provide basic tool set. Possess and maintain timely and reliable transportation. When on-call, be ready, available, fit for work, and able to report to the property within 30 minutes of receiving a call. PI
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Director, Value & Access Marketing & Operations Company: Albireo Pharma Job Description: The Director, Value and Access, Marketing & Operations will be accountable for developing, refining and executing innovative, integrated programs across various channels at the time of launches and beyond to drive sustained brand growth. Key components of this role will include Value Proposition development, creation of Value & Access marketing materials, agency management, budget management, competitive strategy, annual business and strategic plans, message development and execution. It will require collaboration with Value & Access partners, marketing and multiple agencies to ensure strategies and tactics are well integrated across the brand campaign and meet brand priorities. The Director, V&A, Marketing & Operations reports to the Head of V&A Marketing & Strategic Operations and will support them in their role as Chief of Staff for V&A. In partnership with the V&A Leadership Team, this person helps to define objectives for the V&A organization, shape the culture, and drive effective alignment within the V&A Business Unit and across other business units and functions at Ipsen. This role requires active engagement with senior leaders, cross functional partners and the entire Value & Access team to communicate opportunities for increased efficiency and/or effectiveness and to establish and administer key business processes. Main Responsibilities: Marketing (70% of the role) Determine marketing resource needs for all V&A groups (Corporate Accounts, National and Regional Accounts, Trade, Field Reimbursement, Pricing & Contracting, and Patient Services) Develop value propositions for formulary decision makers (Payers, PBMs, GPOs, Institutions) Collaborate with Marketing to determine marketing resources needs from V&A Co-Design, with V&A Groups and considering Brand priorities, the strategic priorities for V&A resources (different pieces for V&A use and for field sales use) for each brand Represent the V&A Team in key Brand activities including: annual planning, pull-through, product launch, training, forecasting, etc Work with Marketing and Marketing vendors to review and create pieces aligned with the strategy, prioritizing strategic brands, and to streamline currently used V&A Tools Sheppard resources through the Promotional Review Committee (PRC) process Operations (30% of the role) Lead and manage critical business planning frameworks and activities, including but not limited to, budget management, business reviews, business unit executive meeting content, senior leadership briefings and presentations, and other key strategic and tactical processes. Lead "above brand" initiatives such as the Value & Access Corporate overview presentation, Value & Access Capabilities presentation, payer pull-through process, and MyIpsen Value & Access website. Serve as the BU lead for all aspects of POA meeting planning and execution of POAs including Leaders Meetings, National Business Meeting. Primary BU liaison with Sales Operations, sales training, meetings/conventions and field communications In partnership with Head of Pricing & Contracting, lead Contract administration, including contract performance reporting and administration Abilities, Education and Qualifications: BA/BS in a related field is required; advanced degree is preferred Previous experience with a focus on payer marketing preferred, 8-10 years desired Previous experience working with agencies on creation of materials Previous experience working with promotional material review committees (legal, regulatory, medical) and managing new product launch or label expansion Strong project management skills, setting and executing against deadlines and delivering on commitments Experience with both Pharmacy and Medical benefit products, with knowledge of Rare, Oncology and Neurology preferred Excellent communication and collaboration skills IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
05/26/2023
Full time
Title: Director, Value & Access Marketing & Operations Company: Albireo Pharma Job Description: The Director, Value and Access, Marketing & Operations will be accountable for developing, refining and executing innovative, integrated programs across various channels at the time of launches and beyond to drive sustained brand growth. Key components of this role will include Value Proposition development, creation of Value & Access marketing materials, agency management, budget management, competitive strategy, annual business and strategic plans, message development and execution. It will require collaboration with Value & Access partners, marketing and multiple agencies to ensure strategies and tactics are well integrated across the brand campaign and meet brand priorities. The Director, V&A, Marketing & Operations reports to the Head of V&A Marketing & Strategic Operations and will support them in their role as Chief of Staff for V&A. In partnership with the V&A Leadership Team, this person helps to define objectives for the V&A organization, shape the culture, and drive effective alignment within the V&A Business Unit and across other business units and functions at Ipsen. This role requires active engagement with senior leaders, cross functional partners and the entire Value & Access team to communicate opportunities for increased efficiency and/or effectiveness and to establish and administer key business processes. Main Responsibilities: Marketing (70% of the role) Determine marketing resource needs for all V&A groups (Corporate Accounts, National and Regional Accounts, Trade, Field Reimbursement, Pricing & Contracting, and Patient Services) Develop value propositions for formulary decision makers (Payers, PBMs, GPOs, Institutions) Collaborate with Marketing to determine marketing resources needs from V&A Co-Design, with V&A Groups and considering Brand priorities, the strategic priorities for V&A resources (different pieces for V&A use and for field sales use) for each brand Represent the V&A Team in key Brand activities including: annual planning, pull-through, product launch, training, forecasting, etc Work with Marketing and Marketing vendors to review and create pieces aligned with the strategy, prioritizing strategic brands, and to streamline currently used V&A Tools Sheppard resources through the Promotional Review Committee (PRC) process Operations (30% of the role) Lead and manage critical business planning frameworks and activities, including but not limited to, budget management, business reviews, business unit executive meeting content, senior leadership briefings and presentations, and other key strategic and tactical processes. Lead "above brand" initiatives such as the Value & Access Corporate overview presentation, Value & Access Capabilities presentation, payer pull-through process, and MyIpsen Value & Access website. Serve as the BU lead for all aspects of POA meeting planning and execution of POAs including Leaders Meetings, National Business Meeting. Primary BU liaison with Sales Operations, sales training, meetings/conventions and field communications In partnership with Head of Pricing & Contracting, lead Contract administration, including contract performance reporting and administration Abilities, Education and Qualifications: BA/BS in a related field is required; advanced degree is preferred Previous experience with a focus on payer marketing preferred, 8-10 years desired Previous experience working with agencies on creation of materials Previous experience working with promotional material review committees (legal, regulatory, medical) and managing new product launch or label expansion Strong project management skills, setting and executing against deadlines and delivering on commitments Experience with both Pharmacy and Medical benefit products, with knowledge of Rare, Oncology and Neurology preferred Excellent communication and collaboration skills IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Ipsen is seeking an Associate Director, Brand Analytics, Oncology to help drive the analytics supporting our North American Oncology business unit. The AD will be part of the Commercial Information Management & Enablement (CIME) function with a reporting line to the Director of Brand Analytics. Job Summary : The AD will drive analytics through secondary data to uncover opportunities and deeper insights across the competitive landscape. This role is responsible for driving new analytics capabilities, lead secondary analytics & insights on new launches, acquisitions, market sizing and business rules, and subsequent growth tracking of our various Oncology brands. In addition, this role supports ad hoc analyses, business KPIs, KPI definitions and insights delivery for brand teams. The successful candidate in this role is expected to have a strong understanding of the pharmaceutical business, in order to support the CIME and Oncology team in the following areas: - Performance and growth tracking - Brand metrics & KPIs - Insights Generation from Secondary data - Launch Insights & Planning - Forecasting & Segmentation Main Responsibilities & Expectations : Collaborate closely with the CIME team and cross-functional brand teams across the Ipsen North America Oncology portfolio Serve as 1st line of contact for Oncology brand teams on questions, issues and ad-hoc requests and analytics requests Support brand strategic objectives from data analytics, forecasting, and competitive and market intelligence Proactively engage Stakeholders to refine metrics, KPIs, Business Rules and explore secondary data to uncover additional insights Provide project management oversight on analytics initiatives Manage contractors & consultants, along with day-to-day task delegation Foster a culture of innovation and agile ways of working with strategic partners by taking part in the execution of proof of concepts, pilots, and projects based on cutting edge technologies Stay current on data & analytics trends, approaches, methodologies and champion internal and new analytics capabilities Deliver effective presentations of findings and recommendations to multiple levels of leadership through various communication channels Knowledge, Abilities & Experiences: BA/BS in a related field is required 5+ years of Pharma/Biotech/MedTech experience, with the last 3+ years being in a hands-on data analytics role Deep understanding of biopharma commercial and patient level data, including but not limited to: Claims, Specialty Pharmacy, Specialty Distributor, Sales, RWE, Lab, etc. Experience in designing, implementing and using advanced analytical methodologies to support brand & competitor insights Understanding of business KPIs; knowledgeable in current and possible future data, trends, and information affecting the pharma industry, business and organization Familiarity with brand / marketing analytics or a decision sciences function and experience with advanced quantitative methods is a strong plus (e.g. segmentation, forecasting, predictive modelling, etc.) Advanced analytics and data visualization skills using Excel as well as Tableau / Power BI for data analytics, visualization and modelling Strong communication skills with ability to clearly deliver and articulate key findings to business partners, effective presentations & trainings Ability to get hands on, when needed, while focusing on the bigger picture and outcomes Able to work a hybrid work arrangement including a mix of in-office and remote working (ideally prefer candidates local to the Boston/Cambridge, MA area)
05/26/2023
Full time
Ipsen is seeking an Associate Director, Brand Analytics, Oncology to help drive the analytics supporting our North American Oncology business unit. The AD will be part of the Commercial Information Management & Enablement (CIME) function with a reporting line to the Director of Brand Analytics. Job Summary : The AD will drive analytics through secondary data to uncover opportunities and deeper insights across the competitive landscape. This role is responsible for driving new analytics capabilities, lead secondary analytics & insights on new launches, acquisitions, market sizing and business rules, and subsequent growth tracking of our various Oncology brands. In addition, this role supports ad hoc analyses, business KPIs, KPI definitions and insights delivery for brand teams. The successful candidate in this role is expected to have a strong understanding of the pharmaceutical business, in order to support the CIME and Oncology team in the following areas: - Performance and growth tracking - Brand metrics & KPIs - Insights Generation from Secondary data - Launch Insights & Planning - Forecasting & Segmentation Main Responsibilities & Expectations : Collaborate closely with the CIME team and cross-functional brand teams across the Ipsen North America Oncology portfolio Serve as 1st line of contact for Oncology brand teams on questions, issues and ad-hoc requests and analytics requests Support brand strategic objectives from data analytics, forecasting, and competitive and market intelligence Proactively engage Stakeholders to refine metrics, KPIs, Business Rules and explore secondary data to uncover additional insights Provide project management oversight on analytics initiatives Manage contractors & consultants, along with day-to-day task delegation Foster a culture of innovation and agile ways of working with strategic partners by taking part in the execution of proof of concepts, pilots, and projects based on cutting edge technologies Stay current on data & analytics trends, approaches, methodologies and champion internal and new analytics capabilities Deliver effective presentations of findings and recommendations to multiple levels of leadership through various communication channels Knowledge, Abilities & Experiences: BA/BS in a related field is required 5+ years of Pharma/Biotech/MedTech experience, with the last 3+ years being in a hands-on data analytics role Deep understanding of biopharma commercial and patient level data, including but not limited to: Claims, Specialty Pharmacy, Specialty Distributor, Sales, RWE, Lab, etc. Experience in designing, implementing and using advanced analytical methodologies to support brand & competitor insights Understanding of business KPIs; knowledgeable in current and possible future data, trends, and information affecting the pharma industry, business and organization Familiarity with brand / marketing analytics or a decision sciences function and experience with advanced quantitative methods is a strong plus (e.g. segmentation, forecasting, predictive modelling, etc.) Advanced analytics and data visualization skills using Excel as well as Tableau / Power BI for data analytics, visualization and modelling Strong communication skills with ability to clearly deliver and articulate key findings to business partners, effective presentations & trainings Ability to get hands on, when needed, while focusing on the bigger picture and outcomes Able to work a hybrid work arrangement including a mix of in-office and remote working (ideally prefer candidates local to the Boston/Cambridge, MA area)
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Business Operations Specialist Company: Ipsen Biopharmaceuticals Inc. Job Description: The Business Operations Specialist will evaluate, develop, plan, organize and manage brand planning (process and templates), coordination of corporate and financial calendars (BR, F1/F2, budget, strategic planning, etc.), and support the development and execution of the overall communication and change management plan. The specialist will will partner with Communications Liaison and Leadership and partner with the Operations Team to ensure strategic alignment on call plans and incentive compensation. Job Responsibilities & Expectations Directs, implements, coordinates, plans for and evaluates the business operations for the organization, which may include reporting, decision and budget support, planning, and process improvement. Develops and ensures adherence to the departments annual budget, in accordance with IPSEN guidelines and policies. Participates in financial analysis and planning including monitoring and reporting on monthly budget variances and opportunities to improve performance Advances strategic financial plan and makes recommendations to senior management on how to best execute the departments plan. Formulates department policies and guidelines to carry out IPSEN's mission. Monitors contractual obligations and ensures consistency with departmental budget, goals, and programmatic initiatives Procurement: creation of Purchase orders and management of orders, invoices, payments, deliveries, receptions Knowledge, Abilities and Education BA/BS, ideally is a business or management related field 3-5 years of similar / relevant operations related experience, ideally within pharmaceuticals, biotech or life sciences Working knowledge of organizational strategic and organizational planning A can-do attitude, problem-solving orientation and a constant Customer Service Focus are a must for this position Strong organization, time management and project coordination skills Capacity to handle multiple tasks simultaneously - in an efficient way especially when working both on multiple instant user requests, and long-term projects Strong interpersonal communication skills with the ability to interface with individuals from a variety of roles and cultures Ability to work as part of a team in a fast-paced environment, as well as independently, and to adapt quickly to changes Proficient with Microsoft Office (Outlook, Excel, Word and PowerPoint) and various IT systems Local to Cambridge, MA with the ability to work in a hybrid/flex model including a mix of in-office, remote working and business travel when needed IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
05/25/2023
Full time
Title: Business Operations Specialist Company: Ipsen Biopharmaceuticals Inc. Job Description: The Business Operations Specialist will evaluate, develop, plan, organize and manage brand planning (process and templates), coordination of corporate and financial calendars (BR, F1/F2, budget, strategic planning, etc.), and support the development and execution of the overall communication and change management plan. The specialist will will partner with Communications Liaison and Leadership and partner with the Operations Team to ensure strategic alignment on call plans and incentive compensation. Job Responsibilities & Expectations Directs, implements, coordinates, plans for and evaluates the business operations for the organization, which may include reporting, decision and budget support, planning, and process improvement. Develops and ensures adherence to the departments annual budget, in accordance with IPSEN guidelines and policies. Participates in financial analysis and planning including monitoring and reporting on monthly budget variances and opportunities to improve performance Advances strategic financial plan and makes recommendations to senior management on how to best execute the departments plan. Formulates department policies and guidelines to carry out IPSEN's mission. Monitors contractual obligations and ensures consistency with departmental budget, goals, and programmatic initiatives Procurement: creation of Purchase orders and management of orders, invoices, payments, deliveries, receptions Knowledge, Abilities and Education BA/BS, ideally is a business or management related field 3-5 years of similar / relevant operations related experience, ideally within pharmaceuticals, biotech or life sciences Working knowledge of organizational strategic and organizational planning A can-do attitude, problem-solving orientation and a constant Customer Service Focus are a must for this position Strong organization, time management and project coordination skills Capacity to handle multiple tasks simultaneously - in an efficient way especially when working both on multiple instant user requests, and long-term projects Strong interpersonal communication skills with the ability to interface with individuals from a variety of roles and cultures Ability to work as part of a team in a fast-paced environment, as well as independently, and to adapt quickly to changes Proficient with Microsoft Office (Outlook, Excel, Word and PowerPoint) and various IT systems Local to Cambridge, MA with the ability to work in a hybrid/flex model including a mix of in-office, remote working and business travel when needed IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Digital Library Federation
Cambridge, Massachusetts
Harvard University Information Technology (HUIT) is a community of Information Technology professionalscommitted to delivering service and technological solutions in support of teaching, learning, research and administration. We are recruiting an IT workforce that has both breadth in their ability to collaborate and innovate across disciplines - and depth in specific areas of expertise. HUIT offers opportunities for IT professionals to learn and work in a unique technology landscape and service-focused environment. If you are a technically proficient, nimble, user-focused and accountable IT professional who also connects with the importance of collaborating well in a team environment, we are looking for you! This is a fully benefited, full-time Harvard University position that has been funded for two-year through 6/30/25. There is the possibility of renewal, contingent on funding, university priorities and satisfactory job performance. Position Description: The Library Technology Services (LTS) team at Harvard University is seeking an inquisitive and motivated Digital Library Data Engineer (DLDE) to join our exciting project to build the university's next generation Digital Preservation System (DPS). This role will be responsible for the design, development, and maintenance of data APIs, extract/load/transform (ETL) activities, helping to manage data migration from existing data endpoints to the new systems and defining data integration services for our application portfolio. The DLDEwill collaborate with cross-functional teams across all phases of DPS project including requirements analysis, design, development, testing, deployment, and maintenance. Principal Duties and Responsibilities (Essential Functions ) Responsible for overall data management design and construction, ensuring optimization of data access, integration, and utilization. Manage interface and connectivity between multiple data storage sources using advanced database administration expertise. Lead aspects of data management services which may include database and analytics platform researchand design, database performance and optimization, recovery/load strategy and implementation, and datamodeling Collaborate to prepare data verification and testing methods for data/applications loaded into the warehouse, or other data repositories, to ensure compatibility across different sources, and withbusiness partners to determine needs and evaluate solutions Code, develop, and document complex scripts integration mappings and workflows, and stored procedures Provide technical expertise and direction in developing and supporting system level programs, andtraining to clients and staff Troubleshoot advanced data problems and recommend appropriate action Create new or enhanced components of data architecture and interfaces May function as subject matter expert or project lead Actively contribute to formulation of plans and policies Abide by and follow the Harvard University IT technical standards, policies and Code of Conduct Basic Qualifications: Minimum of five years' post-secondary education or relevant work experience Additional Qualifications and Skills: The following Additional Qualifications are strongly preferred. If you meet some, but not all, you are still encouraged to apply; we value employees with a willingness to learn. Ability to code in Python and/or Javascript/NodeJS, and to specify and/or build data bound API services Familiarity with Oracle, Postgresql and MySQL, strong database skills in one Knowledge of information technology applications, processes, software and equipment, andAdvanced knowledge of ETL (Extraction, Transformation, and Loading), reporting and database technologies Advanced communication, technical and project management skills Demonstrated team performance skills, service mindset approach, and the ability to act as a trusted advisor. Work Format Hybrid (partially on-site, partially remote) Working Conditions: HUIT actively supports hybrid work where business needs allow. All remote work must be performed in a state in which Harvard is registered to do business (CA, CT, GA, IL, MA, MD, ME, NH, NJ, NY, RI, VA, VT, and WA). This position can be Onsite, Hybrid, or Primarily remote. Travel to campus may be necessary based on business needs and the nature of work. Examples include bi-annual or quarterly Town Halls, critical business meetings or other work events. Advance notice will be provided. Additional detail will be discussed during the interview process. Harvard University continues to place the highest priority on the health, safety and wellbeing of its faculty, staff, and students, as well as the wider community. Please note that all new employees will be required to provide confirmation of primary series COVID-19 vaccination upon hire, as detailed on our COVID-19 Vaccine Requirement Webpage . Harvard University Health Services employees and other health care individuals are also required to be up to date on vaccination as described by the CDC. Individuals may claim exemption from the vaccine requirement for medical or religious reasons. Additional information regarding this requirement, exemptions, verification of vaccination status, and other related policies and resources may be found on the University's COVID-19 Information Website . Additional Information: Please note: Harvard University requires pre-employment reference and background screening. Harvard University Information Technology is unable to provide work authorization and/or visa sponsorship. This positionhas a 180-day orientation and review period. More about HUIT: Harvard University Information Technology (HUIT) is responsible for the strategy, planning, and delivery of information technology across the University. Our mission is to assure Harvard's leadership in IT. We strive to make it easier for faculty, students, and staff to teach, research, learn and work through the effective use of information technology. HUIT's core values are: User-focused Collaborative Innovative Open IT Academy (designed for IT Staff): HUIT's IT Academy aims to enable each IT staff person to grow professionally and become a trusted partner to her or his team. The IT Academy is built on the belief that every IT staff member across the University (including technology employees at each school and campus) can grow in her or his area of expertise as well as building strong people and project management skills. Learn more here: Benefits: We invite you to visit Harvard's Total Rewards website to learn more about our outstanding benefits package, which may include: Paid Time Off:3-4 weeks of accrued vacation time per year (3 weeks for support staff and 4 weeks for administrative/professional staff), 12 accrued sick days per year, 12.5 holidays plus a Winter Recess in December/January, 3 personal days per year (prorated based on date of hire), and up to 12 weeks of paid leave for new parents who are primary care givers. Health and Welfare:Comprehensive medical, dental, and vision benefits, disability and life insurance programs, along with voluntary benefits. Most coverage begins as of your start date. Work/Life and Wellness:Child and elder/adult care resources including on campus childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation, and more. Retirement:University-funded retirement plan with contributions from 5% to 15% of eligible compensation, based on age and earnings with full vesting after 3 years of service. Tuition Assistance Program:Competitive program including $40 per class at the Harvard Extension School and reduced tuition through other participating Harvard graduate schools. Tuition Reimbursement:Program that provides 75% to 90% reimbursement up to $5,250 per calendar year for eligible courses taken at other accredited institutions. Professional Development:Programs and classes at little or no cost, including through the Harvard Center for Workplace Development and LinkedIn Learning. Commuting and Transportation:Various commuter options handled through the Parking Office, including discounted parking, half-priced public transportation passes and pre-tax transit passes, biking benefits, and more. Harvard Facilities Access, Discounts and Perks:Access to Harvard athletic and fitness facilities, libraries, campus events, credit union, and more, as well as discounts to various types of services (legal, financial, etc.) and cultural and leisure activities throughout metro-Boston. Commitment to Equity, Diversity, Inclusion, and Belonging: Harvard University views equity, diversity, inclusion, and belonging as the pathway to achieving inclusive excellence and fostering a campus culture where everyone can thrive. We strive to create a community that draws upon the widest possible pool of talent to unify excellence and diversity while fully embracing individuals from varied backgrounds, cultures, races, identities, life experiences, perspectives, beliefs . click apply for full job details
05/24/2023
Full time
Harvard University Information Technology (HUIT) is a community of Information Technology professionalscommitted to delivering service and technological solutions in support of teaching, learning, research and administration. We are recruiting an IT workforce that has both breadth in their ability to collaborate and innovate across disciplines - and depth in specific areas of expertise. HUIT offers opportunities for IT professionals to learn and work in a unique technology landscape and service-focused environment. If you are a technically proficient, nimble, user-focused and accountable IT professional who also connects with the importance of collaborating well in a team environment, we are looking for you! This is a fully benefited, full-time Harvard University position that has been funded for two-year through 6/30/25. There is the possibility of renewal, contingent on funding, university priorities and satisfactory job performance. Position Description: The Library Technology Services (LTS) team at Harvard University is seeking an inquisitive and motivated Digital Library Data Engineer (DLDE) to join our exciting project to build the university's next generation Digital Preservation System (DPS). This role will be responsible for the design, development, and maintenance of data APIs, extract/load/transform (ETL) activities, helping to manage data migration from existing data endpoints to the new systems and defining data integration services for our application portfolio. The DLDEwill collaborate with cross-functional teams across all phases of DPS project including requirements analysis, design, development, testing, deployment, and maintenance. Principal Duties and Responsibilities (Essential Functions ) Responsible for overall data management design and construction, ensuring optimization of data access, integration, and utilization. Manage interface and connectivity between multiple data storage sources using advanced database administration expertise. Lead aspects of data management services which may include database and analytics platform researchand design, database performance and optimization, recovery/load strategy and implementation, and datamodeling Collaborate to prepare data verification and testing methods for data/applications loaded into the warehouse, or other data repositories, to ensure compatibility across different sources, and withbusiness partners to determine needs and evaluate solutions Code, develop, and document complex scripts integration mappings and workflows, and stored procedures Provide technical expertise and direction in developing and supporting system level programs, andtraining to clients and staff Troubleshoot advanced data problems and recommend appropriate action Create new or enhanced components of data architecture and interfaces May function as subject matter expert or project lead Actively contribute to formulation of plans and policies Abide by and follow the Harvard University IT technical standards, policies and Code of Conduct Basic Qualifications: Minimum of five years' post-secondary education or relevant work experience Additional Qualifications and Skills: The following Additional Qualifications are strongly preferred. If you meet some, but not all, you are still encouraged to apply; we value employees with a willingness to learn. Ability to code in Python and/or Javascript/NodeJS, and to specify and/or build data bound API services Familiarity with Oracle, Postgresql and MySQL, strong database skills in one Knowledge of information technology applications, processes, software and equipment, andAdvanced knowledge of ETL (Extraction, Transformation, and Loading), reporting and database technologies Advanced communication, technical and project management skills Demonstrated team performance skills, service mindset approach, and the ability to act as a trusted advisor. Work Format Hybrid (partially on-site, partially remote) Working Conditions: HUIT actively supports hybrid work where business needs allow. All remote work must be performed in a state in which Harvard is registered to do business (CA, CT, GA, IL, MA, MD, ME, NH, NJ, NY, RI, VA, VT, and WA). This position can be Onsite, Hybrid, or Primarily remote. Travel to campus may be necessary based on business needs and the nature of work. Examples include bi-annual or quarterly Town Halls, critical business meetings or other work events. Advance notice will be provided. Additional detail will be discussed during the interview process. Harvard University continues to place the highest priority on the health, safety and wellbeing of its faculty, staff, and students, as well as the wider community. Please note that all new employees will be required to provide confirmation of primary series COVID-19 vaccination upon hire, as detailed on our COVID-19 Vaccine Requirement Webpage . Harvard University Health Services employees and other health care individuals are also required to be up to date on vaccination as described by the CDC. Individuals may claim exemption from the vaccine requirement for medical or religious reasons. Additional information regarding this requirement, exemptions, verification of vaccination status, and other related policies and resources may be found on the University's COVID-19 Information Website . Additional Information: Please note: Harvard University requires pre-employment reference and background screening. Harvard University Information Technology is unable to provide work authorization and/or visa sponsorship. This positionhas a 180-day orientation and review period. More about HUIT: Harvard University Information Technology (HUIT) is responsible for the strategy, planning, and delivery of information technology across the University. Our mission is to assure Harvard's leadership in IT. We strive to make it easier for faculty, students, and staff to teach, research, learn and work through the effective use of information technology. HUIT's core values are: User-focused Collaborative Innovative Open IT Academy (designed for IT Staff): HUIT's IT Academy aims to enable each IT staff person to grow professionally and become a trusted partner to her or his team. The IT Academy is built on the belief that every IT staff member across the University (including technology employees at each school and campus) can grow in her or his area of expertise as well as building strong people and project management skills. Learn more here: Benefits: We invite you to visit Harvard's Total Rewards website to learn more about our outstanding benefits package, which may include: Paid Time Off:3-4 weeks of accrued vacation time per year (3 weeks for support staff and 4 weeks for administrative/professional staff), 12 accrued sick days per year, 12.5 holidays plus a Winter Recess in December/January, 3 personal days per year (prorated based on date of hire), and up to 12 weeks of paid leave for new parents who are primary care givers. Health and Welfare:Comprehensive medical, dental, and vision benefits, disability and life insurance programs, along with voluntary benefits. Most coverage begins as of your start date. Work/Life and Wellness:Child and elder/adult care resources including on campus childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation, and more. Retirement:University-funded retirement plan with contributions from 5% to 15% of eligible compensation, based on age and earnings with full vesting after 3 years of service. Tuition Assistance Program:Competitive program including $40 per class at the Harvard Extension School and reduced tuition through other participating Harvard graduate schools. Tuition Reimbursement:Program that provides 75% to 90% reimbursement up to $5,250 per calendar year for eligible courses taken at other accredited institutions. Professional Development:Programs and classes at little or no cost, including through the Harvard Center for Workplace Development and LinkedIn Learning. Commuting and Transportation:Various commuter options handled through the Parking Office, including discounted parking, half-priced public transportation passes and pre-tax transit passes, biking benefits, and more. Harvard Facilities Access, Discounts and Perks:Access to Harvard athletic and fitness facilities, libraries, campus events, credit union, and more, as well as discounts to various types of services (legal, financial, etc.) and cultural and leisure activities throughout metro-Boston. Commitment to Equity, Diversity, Inclusion, and Belonging: Harvard University views equity, diversity, inclusion, and belonging as the pathway to achieving inclusive excellence and fostering a campus culture where everyone can thrive. We strive to create a community that draws upon the widest possible pool of talent to unify excellence and diversity while fully embracing individuals from varied backgrounds, cultures, races, identities, life experiences, perspectives, beliefs . click apply for full job details
Cambridge Health Alliance
Cambridge, Massachusetts
Cambridge Health Alliance (CHA) is a well-respected, nationally recognized and award-winning public healthcare system, which receives recognition for our clinical and academic innovations. Our system is comprised of three hospital campuses and an integrated network of both primary and specialty care practices in Cambridge, Somerville and Boston s Metro North Region. CHA is an academic affiliate of both Harvard Medical School (HMS) and Tufts University School of Medicine. Our practices serve an ethnically and socio-economically diverse patient population. CHA is recruiting for the Medical Director of Coding and Care Coordination. As an integral part of the Population Health Management leadership team, the Medical Director drives performance improvement as measured by completeness and accuracy of diagnosis coding across the members of all risk contract panels in addition to working clinically part-time. Work closely with primary care and specialty clinical leadership to accomplish outstanding outcomes to meet and exceed goals Designs and implements initiatives to achieve improved performance on completeness and accuracy of coding Develops strategies to succeed in risk contracts and value-based care Identifies and drives organization and cultural changes need to adapt strategically to changing market demands, technology and internal initiatives Provides guidance and interpretation on issues of medical appropriateness related to diagnosis coding and documentation Provide part time clinical care Engage and motivate clinical department leadership for performance improvement through coaching, skill building, and leadership Ideal candidates will have 5+ years of clinical experience as a licensed/ Board Certified Physician, Physician Assistant, or Nurse Practitioner with one to two years in a clinical leadership role. Candidates should possess strong diagnostic skills, a thorough understanding of all aspects of diagnosis coding, compliant documentation, HCC and HHS coding and risk adjustment models. Proven ability in medical leadership possessing clinical credibility with peers and the ability to be a team player and team builder. In keeping with federal, state and local laws, Cambridge Health Alliance (CHA) policy forbids employees and associates to discriminate against anyone based on race, religion, color, gender, age, marital status, national origin, sexual orientation, relationship identity or relationship structure, gender identity or expression, veteran status, disability or any other characteristic protected by law. We are committed to establishing and maintaining a workplace free of discrimination. We are fully committed to equal employment opportunity. We will not tolerate unlawful discrimination in the recruitment, hiring, termination, promotion, salary treatment or any other condition of employment or career development. Furthermore, we will not tolerate the use of discriminatory slurs, or other remarks, jokes or conduct, that in the judgment of CHA, encourage or permit an offensive or hostile work environment.
05/24/2023
Full time
Cambridge Health Alliance (CHA) is a well-respected, nationally recognized and award-winning public healthcare system, which receives recognition for our clinical and academic innovations. Our system is comprised of three hospital campuses and an integrated network of both primary and specialty care practices in Cambridge, Somerville and Boston s Metro North Region. CHA is an academic affiliate of both Harvard Medical School (HMS) and Tufts University School of Medicine. Our practices serve an ethnically and socio-economically diverse patient population. CHA is recruiting for the Medical Director of Coding and Care Coordination. As an integral part of the Population Health Management leadership team, the Medical Director drives performance improvement as measured by completeness and accuracy of diagnosis coding across the members of all risk contract panels in addition to working clinically part-time. Work closely with primary care and specialty clinical leadership to accomplish outstanding outcomes to meet and exceed goals Designs and implements initiatives to achieve improved performance on completeness and accuracy of coding Develops strategies to succeed in risk contracts and value-based care Identifies and drives organization and cultural changes need to adapt strategically to changing market demands, technology and internal initiatives Provides guidance and interpretation on issues of medical appropriateness related to diagnosis coding and documentation Provide part time clinical care Engage and motivate clinical department leadership for performance improvement through coaching, skill building, and leadership Ideal candidates will have 5+ years of clinical experience as a licensed/ Board Certified Physician, Physician Assistant, or Nurse Practitioner with one to two years in a clinical leadership role. Candidates should possess strong diagnostic skills, a thorough understanding of all aspects of diagnosis coding, compliant documentation, HCC and HHS coding and risk adjustment models. Proven ability in medical leadership possessing clinical credibility with peers and the ability to be a team player and team builder. In keeping with federal, state and local laws, Cambridge Health Alliance (CHA) policy forbids employees and associates to discriminate against anyone based on race, religion, color, gender, age, marital status, national origin, sexual orientation, relationship identity or relationship structure, gender identity or expression, veteran status, disability or any other characteristic protected by law. We are committed to establishing and maintaining a workplace free of discrimination. We are fully committed to equal employment opportunity. We will not tolerate unlawful discrimination in the recruitment, hiring, termination, promotion, salary treatment or any other condition of employment or career development. Furthermore, we will not tolerate the use of discriminatory slurs, or other remarks, jokes or conduct, that in the judgment of CHA, encourage or permit an offensive or hostile work environment.
About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As the Head of Tech Ops IT you will report to the VP, Head of IT and will lead the planning, design, implementation, documentation, and support of various TechOps systems. We are looking for a technical expert with in-depth knowledge, passion, and curiosity to stay up to date with relevant technologies and trends. Important and cool stuff. What you'll do Partner with Tech Ops organization (Process and analytical development, Quality Assurance, Quality Control, Manufacturing & Supply Chain) to understand and develop & execute IT roadmap Select, implement & support various business applications like ERP, MES, LIMS, OSI-PI, PLM etc. Provide IT input into Tech Ops business planning and strategic objectives Partner with internal IT teams to plan and deliver IT infrastructure, projects, and systems in support of Tech Ops operations Manage projects, design solutions & production support related to TechOps applications. Manage external vendors / service providers Work closely with Validation and Quality Assurance (QA) in deploying and supporting GMP IT systems Write SOP's, Work Instructions, and IQ/PQ Protocols Represent IT during inspections and audits Manage Budget related to TechOps systems & experienced people manager & team builder What we're looking for Minimum of 10 years in a pharmaceutical biotechnology environment, preferably in a TechOps IT role as an IT business partner Bachelor's degree in computer science or technical discipline or equivalent Experience Implementing Manufacturing / Supply Chain applications like ERP, MES, LIMS, OSI-PI, EMS, BMS etc. GMP computer systems experience required Bachelor's degree in Computer Science, Engineering or related discipline preferred Proficiency in Microsoft Office, including process mapping/project management tools such as Jira, Smartsheet's, Visio and Project Veeva, LabVantage experience is a plus Familiarity with ERP and Clinical Data Management systems a plus Understands cloud-based/SaaS systems Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company What will separate you from the crowd Experience with core IT domains like infrastructure, operations, and cybersecurity Experience working in a regulated environment Exemplifies teamwork and serves as a role model Ability to communicate effectively and professionally, both orally and in writing, while also articulating and translating technical language to non-technical customers What you should know Some travel will be required Working safely in person on a predictable and regular basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19 The base pay range for this position at commencement of employment is expected to be between $230,000 and $290,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience How we work together Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution Get to know us At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients. Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal . We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law. To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
05/24/2023
Full time
About the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As the Head of Tech Ops IT you will report to the VP, Head of IT and will lead the planning, design, implementation, documentation, and support of various TechOps systems. We are looking for a technical expert with in-depth knowledge, passion, and curiosity to stay up to date with relevant technologies and trends. Important and cool stuff. What you'll do Partner with Tech Ops organization (Process and analytical development, Quality Assurance, Quality Control, Manufacturing & Supply Chain) to understand and develop & execute IT roadmap Select, implement & support various business applications like ERP, MES, LIMS, OSI-PI, PLM etc. Provide IT input into Tech Ops business planning and strategic objectives Partner with internal IT teams to plan and deliver IT infrastructure, projects, and systems in support of Tech Ops operations Manage projects, design solutions & production support related to TechOps applications. Manage external vendors / service providers Work closely with Validation and Quality Assurance (QA) in deploying and supporting GMP IT systems Write SOP's, Work Instructions, and IQ/PQ Protocols Represent IT during inspections and audits Manage Budget related to TechOps systems & experienced people manager & team builder What we're looking for Minimum of 10 years in a pharmaceutical biotechnology environment, preferably in a TechOps IT role as an IT business partner Bachelor's degree in computer science or technical discipline or equivalent Experience Implementing Manufacturing / Supply Chain applications like ERP, MES, LIMS, OSI-PI, EMS, BMS etc. GMP computer systems experience required Bachelor's degree in Computer Science, Engineering or related discipline preferred Proficiency in Microsoft Office, including process mapping/project management tools such as Jira, Smartsheet's, Visio and Project Veeva, LabVantage experience is a plus Familiarity with ERP and Clinical Data Management systems a plus Understands cloud-based/SaaS systems Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company What will separate you from the crowd Experience with core IT domains like infrastructure, operations, and cybersecurity Experience working in a regulated environment Exemplifies teamwork and serves as a role model Ability to communicate effectively and professionally, both orally and in writing, while also articulating and translating technical language to non-technical customers What you should know Some travel will be required Working safely in person on a predictable and regular basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19 The base pay range for this position at commencement of employment is expected to be between $230,000 and $290,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience How we work together Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution Get to know us At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients. Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal . We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law. To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
Dimagi is an award-winning social enterprise and a certified B Corp and Benefit Corporation. Our primary product,CommCare , is the most widely-deployed open-source digital platform for enabling Frontline Workers. Since 2002, Governments and organizations across all sectors have built customized mobile, web, and SMS applications on CommCare to deliver services to underserved populations. Dimagi is more than a tech company. We are an impact-first team of compassionate people from all parts of the world and all walks of life, dedicated to using business as a force for good in global health and development. About The Solutions Division The Solutions Division's mission is to build and scale sustainable, high-impact digital solutions that amplify frontline workers and programs in Low and Middle Income Countries (LMICs). We offer professional services to partners to impactfully deliver Dimagi technology and / or programmatic expertise. About the Position Dimagi is hiring a Senior Partnerships Associate to join our Solutions Division. This position is open to remote employment in the United States, with a preference for a candidate based in Washington, DC or NYC. At Dimagi, we care about impact, team satisfaction, and profit (in that order). Interested in the technology-for-good space? Then consider joining us at Dimagi in this key exciting role. This highly-motivated and dynamic member of our Solutions Division Partnerships team will be a specialist in prospecting, cultivating, selling, and closing of technology products and contract deals. We are seeking someone with an understanding of international development, specifically within the global health sector. The Senior Partnerships Associate will be responsible for liaising with mid and senior level management of multiple international development associations to plan some of the world's largest and most impactful global development projects at the inception stage. You will help serve our traditional clients on short notice, provide expert advice on costs and feasibility of their projects, and serve to enable our global team to work more efficiently by bringing new perspectives to current internal business processes. You should have excellent organizational skills and be able to facilitate complex partnerships within very tight deadlines. Ideally, you'll have a familiarity with US and other major international donor assistance government contracting mechanisms (USAID, CDC, DFID, or otherwise) in the international aid sector. You should have excellent writing and research skills, good analytical reasoning, and keen attention to detail. This position is ideal for motivated professionals seeking a leadership career track with a leading ICT4D organization. Responsibilities The successful candidate will be flexible and willing to take on various types of tasks, reliable in delivering results as required, and have an extremely keen judgment to determine prioritization. You will help with various business development and partnership development tasks, including but not limited to: Business Intelligence: forecast information on upcoming RFPs and funding opportunities for all major funding agencies and all sectors pertinent to the Africa region and, if feasible, to West Africa in particular. Prospecting: Identify different leads and opportunities within new potential geographical regions, as well as identifying important conferences, workshops, or networking spaces in the region pertinent to ICT4D. Account Management: Work with select partners to create actionable partnerships and new project opportunities. Opportunity Management: Supporting different competitive RFPs and opportunities through the completion of partnership packages when needed to sell Dimagi'sprofessional services offerings directly to clients and partners. Create budgets, scopes of work and parse legal documents as necessary. Comfortable problem-solving in real-time and explaining high-level healthcare infrastructure and technologies to unfamiliar audiences. Supporting our Global Business Development teams on: Refining partnership collateral and help giving structure to country-specific information as needed. Generating analysis and reports from our Salesforce data, both one-off requests and managing recurring processes. Maintaining our Business Development Knowledge Management (wiki, website, study cases, country-specific examples) Providing support to other country office partnerships as needed and appropriate 2+ years of experience in the social and international development sector, preferably in a partnerships or proposal development role Outstanding oral and written communication skills Knowledge of budgets, proposal development, and strategic analysis Adept at negotiation A strong ability to engage and grow a network of stakeholders. Ability to be target-driven while also being a supportive member of the greater Partnerships Team Ability to travel 1-2 weeks per year for conferences and internal workshops Bonus Points Fluent in Spanish Prior experience forming and negotiating partnerships within the international development sector, particularly with governments Understand ICT4D technologies such as CommCare, OpenMRS or DHIS2 Degree in development studies or business administration Proficiency with Salesforce or equivalent CRM Benefits and Compensation We aim to make a difference, not just as a company but also as an employer. We are transparent about salaries at all levels of the organization and have a standard, global pay scale for all positions. Our salaries are cost of living adjusted and non-negotiable. The estimated salary range for this position is USD 44,555 to USD 69,173 annually. Your final salary within the range will be dependent on where you are geographically based and might fall outside of this estimated range. The benefits we offer are geared towards having a strong impact on our staff's well-being. A few of our key benefits are outlined below: 100% employer-sponsored medical insurance paired with a generous Health Reimbursement Account (HRA) fund Access to voluntary dental and vision insurance plans A 401K plan with up to a 4% employer match Employee stock option plan 30 days paid time off inclusive of holidays Unlimited sick time and excellent parental leave policy Access to a flex-time policy that allows employees to work based on a flexible work schedule Professional Development Benefit Access to an Employee Assistance Program (EAP) through Magellan Healthcare EEO Employer/Veteran/Disabled Dimagi is an Equal Opportunity Employer. We celebrate and support diversity and are committed to providing a work environment that is inclusive and free of discrimination and harassment.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are interested in applying for employment and need special assistance or a reasonable accommodation during the application or interview process for a posted position, please contact us at or send an email detailing your request.
05/24/2023
Full time
Dimagi is an award-winning social enterprise and a certified B Corp and Benefit Corporation. Our primary product,CommCare , is the most widely-deployed open-source digital platform for enabling Frontline Workers. Since 2002, Governments and organizations across all sectors have built customized mobile, web, and SMS applications on CommCare to deliver services to underserved populations. Dimagi is more than a tech company. We are an impact-first team of compassionate people from all parts of the world and all walks of life, dedicated to using business as a force for good in global health and development. About The Solutions Division The Solutions Division's mission is to build and scale sustainable, high-impact digital solutions that amplify frontline workers and programs in Low and Middle Income Countries (LMICs). We offer professional services to partners to impactfully deliver Dimagi technology and / or programmatic expertise. About the Position Dimagi is hiring a Senior Partnerships Associate to join our Solutions Division. This position is open to remote employment in the United States, with a preference for a candidate based in Washington, DC or NYC. At Dimagi, we care about impact, team satisfaction, and profit (in that order). Interested in the technology-for-good space? Then consider joining us at Dimagi in this key exciting role. This highly-motivated and dynamic member of our Solutions Division Partnerships team will be a specialist in prospecting, cultivating, selling, and closing of technology products and contract deals. We are seeking someone with an understanding of international development, specifically within the global health sector. The Senior Partnerships Associate will be responsible for liaising with mid and senior level management of multiple international development associations to plan some of the world's largest and most impactful global development projects at the inception stage. You will help serve our traditional clients on short notice, provide expert advice on costs and feasibility of their projects, and serve to enable our global team to work more efficiently by bringing new perspectives to current internal business processes. You should have excellent organizational skills and be able to facilitate complex partnerships within very tight deadlines. Ideally, you'll have a familiarity with US and other major international donor assistance government contracting mechanisms (USAID, CDC, DFID, or otherwise) in the international aid sector. You should have excellent writing and research skills, good analytical reasoning, and keen attention to detail. This position is ideal for motivated professionals seeking a leadership career track with a leading ICT4D organization. Responsibilities The successful candidate will be flexible and willing to take on various types of tasks, reliable in delivering results as required, and have an extremely keen judgment to determine prioritization. You will help with various business development and partnership development tasks, including but not limited to: Business Intelligence: forecast information on upcoming RFPs and funding opportunities for all major funding agencies and all sectors pertinent to the Africa region and, if feasible, to West Africa in particular. Prospecting: Identify different leads and opportunities within new potential geographical regions, as well as identifying important conferences, workshops, or networking spaces in the region pertinent to ICT4D. Account Management: Work with select partners to create actionable partnerships and new project opportunities. Opportunity Management: Supporting different competitive RFPs and opportunities through the completion of partnership packages when needed to sell Dimagi'sprofessional services offerings directly to clients and partners. Create budgets, scopes of work and parse legal documents as necessary. Comfortable problem-solving in real-time and explaining high-level healthcare infrastructure and technologies to unfamiliar audiences. Supporting our Global Business Development teams on: Refining partnership collateral and help giving structure to country-specific information as needed. Generating analysis and reports from our Salesforce data, both one-off requests and managing recurring processes. Maintaining our Business Development Knowledge Management (wiki, website, study cases, country-specific examples) Providing support to other country office partnerships as needed and appropriate 2+ years of experience in the social and international development sector, preferably in a partnerships or proposal development role Outstanding oral and written communication skills Knowledge of budgets, proposal development, and strategic analysis Adept at negotiation A strong ability to engage and grow a network of stakeholders. Ability to be target-driven while also being a supportive member of the greater Partnerships Team Ability to travel 1-2 weeks per year for conferences and internal workshops Bonus Points Fluent in Spanish Prior experience forming and negotiating partnerships within the international development sector, particularly with governments Understand ICT4D technologies such as CommCare, OpenMRS or DHIS2 Degree in development studies or business administration Proficiency with Salesforce or equivalent CRM Benefits and Compensation We aim to make a difference, not just as a company but also as an employer. We are transparent about salaries at all levels of the organization and have a standard, global pay scale for all positions. Our salaries are cost of living adjusted and non-negotiable. The estimated salary range for this position is USD 44,555 to USD 69,173 annually. Your final salary within the range will be dependent on where you are geographically based and might fall outside of this estimated range. The benefits we offer are geared towards having a strong impact on our staff's well-being. A few of our key benefits are outlined below: 100% employer-sponsored medical insurance paired with a generous Health Reimbursement Account (HRA) fund Access to voluntary dental and vision insurance plans A 401K plan with up to a 4% employer match Employee stock option plan 30 days paid time off inclusive of holidays Unlimited sick time and excellent parental leave policy Access to a flex-time policy that allows employees to work based on a flexible work schedule Professional Development Benefit Access to an Employee Assistance Program (EAP) through Magellan Healthcare EEO Employer/Veteran/Disabled Dimagi is an Equal Opportunity Employer. We celebrate and support diversity and are committed to providing a work environment that is inclusive and free of discrimination and harassment.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are interested in applying for employment and need special assistance or a reasonable accommodation during the application or interview process for a posted position, please contact us at or send an email detailing your request.
Omega Therapeutics is a Clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform. The OMEGA platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systemic, rational and integrative drug design, the OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers , target specific intervention points amongst the thousands of mapped and validated proprietary and novel DNA-sequence-based epigenomic loci, EpiZips to durably tune single or multiple genes to treat and cure disease through Precision Genomic Control . Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases. About the Role: Omega Therapeutics, Inc. is seeking a highly innovative and experienced Head of Drug Delivery and Formulation (VP level) to join our growing R&D team. Reporting to the Chief Scientific Officer, this role will lead the design, development and implementation of novel formulations for Omega's Epigenomic Programming platform products. They will be responsible for defining strategies, overseeing design and execution of empirical studies, and managing the technical and operational aspects of our drug formulatin and delivery team. They will be an experienced leader with a strong background in LNP formulation discovery, technical development and optimization, including design and screening of lipid nanoparticle (LNP) libraries. They will provide expertise and leadership to internal and partnered therapeutic programs, and will collaborate with interdisciplinary teams within R&D to develop and manage formulation and delivery strategy, plans, timelines, key deliverables, and reporting to achieve Omega's company-wide initiatives. Key Responsibilities: Design strategies for developing formulations and drug product, including early process development and scale-up, for preclinical, and clinical studies Responsible for developing and executing innovative (LNP and non-LNP) drug delivery strategies, approaches and technologies Author and oversee preparation of technical reports, data summaries and formulation-related Nonclinical and CMC-related regulatory submission documents and module sections Identify relevant academic and industry collaboration partners, CROs, and state-of-the-art technologies to further develop Omega's platform and pipeline Build and maintain effective partnerships with internal and external key stakeholders and CROs to ensure high quality and on-time execution Represent Drug delivery and Formulation function on multidisciplinary project teams, working collaboratively to ensure project progression Collaborate in a fast-paced, interdisciplinary team environment with all related and stakeholder functions within drug development (i.e., discovery research, nonclinical development, process and analytical development, regulatory and clinical) to ensure comprehensive assessment of product formulation properties as key aspect of compound optimization and candidate selection Work with eary research teams to develop fit-for-purpose early formulations to support in vitro and in vivo (pharmacology, DMPK) studies Manage and mentor the growing Formulation and Drug Delivery team, including resource planning, budgets, staff development, and performance management Required Skills: Demonstrated ability to lead, build and manage an innovative and collaborative team Broad experience using a wide variety of formulation concepts across multiple development programs to deliver to a project's Target Product Profile A proven track record in designing, screening, optimizing, characterizing and developing lipid nanoparticle (LNP) formulations from preclinical through late-stage clinical development Extensive hands-on experience in the development of novel formulation technologies Ability to assess the formulation and process technologies landscape to effectively identify and implement enabling formulation technologies or unique delivery systems Proficiency with Quality by Design (QbD) concepts and design of experiments (DoE) Experience as primary author of relevant sections of INDs and other regulatory documents Strong analytical, problem solving and critical thinking skills Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership Required Qualifications: Graduate degree in life sciences, chemistry, or related field with 15+ years' experience in the Biotech/pharma industry (advanced degree preferred) A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment Experienced leader and scientist with a strong background in discovery and development of novel formulations, including lipid nanoparticles (LNP) vehicles. Available to travel if/when needed
05/23/2023
Full time
Omega Therapeutics is a Clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform. The OMEGA platform harnesses the power of epigenetics, the mechanism that controls gene expression and every aspect of an organism's life from cell genesis, growth and differentiation to cell death. Using a suite of technologies, paired with Omega's process of systemic, rational and integrative drug design, the OMEGA platform enables control of fundamental epigenetic processes to correct the root cause of disease by returning aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega's engineered, modular, and programmable mRNA-encoded epigenetic medicines, Omega Epigenomic Controllers , target specific intervention points amongst the thousands of mapped and validated proprietary and novel DNA-sequence-based epigenomic loci, EpiZips to durably tune single or multiple genes to treat and cure disease through Precision Genomic Control . Omega is currently advancing a broad pipeline of development candidates spanning a range of disease areas, including oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases. About the Role: Omega Therapeutics, Inc. is seeking a highly innovative and experienced Head of Drug Delivery and Formulation (VP level) to join our growing R&D team. Reporting to the Chief Scientific Officer, this role will lead the design, development and implementation of novel formulations for Omega's Epigenomic Programming platform products. They will be responsible for defining strategies, overseeing design and execution of empirical studies, and managing the technical and operational aspects of our drug formulatin and delivery team. They will be an experienced leader with a strong background in LNP formulation discovery, technical development and optimization, including design and screening of lipid nanoparticle (LNP) libraries. They will provide expertise and leadership to internal and partnered therapeutic programs, and will collaborate with interdisciplinary teams within R&D to develop and manage formulation and delivery strategy, plans, timelines, key deliverables, and reporting to achieve Omega's company-wide initiatives. Key Responsibilities: Design strategies for developing formulations and drug product, including early process development and scale-up, for preclinical, and clinical studies Responsible for developing and executing innovative (LNP and non-LNP) drug delivery strategies, approaches and technologies Author and oversee preparation of technical reports, data summaries and formulation-related Nonclinical and CMC-related regulatory submission documents and module sections Identify relevant academic and industry collaboration partners, CROs, and state-of-the-art technologies to further develop Omega's platform and pipeline Build and maintain effective partnerships with internal and external key stakeholders and CROs to ensure high quality and on-time execution Represent Drug delivery and Formulation function on multidisciplinary project teams, working collaboratively to ensure project progression Collaborate in a fast-paced, interdisciplinary team environment with all related and stakeholder functions within drug development (i.e., discovery research, nonclinical development, process and analytical development, regulatory and clinical) to ensure comprehensive assessment of product formulation properties as key aspect of compound optimization and candidate selection Work with eary research teams to develop fit-for-purpose early formulations to support in vitro and in vivo (pharmacology, DMPK) studies Manage and mentor the growing Formulation and Drug Delivery team, including resource planning, budgets, staff development, and performance management Required Skills: Demonstrated ability to lead, build and manage an innovative and collaborative team Broad experience using a wide variety of formulation concepts across multiple development programs to deliver to a project's Target Product Profile A proven track record in designing, screening, optimizing, characterizing and developing lipid nanoparticle (LNP) formulations from preclinical through late-stage clinical development Extensive hands-on experience in the development of novel formulation technologies Ability to assess the formulation and process technologies landscape to effectively identify and implement enabling formulation technologies or unique delivery systems Proficiency with Quality by Design (QbD) concepts and design of experiments (DoE) Experience as primary author of relevant sections of INDs and other regulatory documents Strong analytical, problem solving and critical thinking skills Excellent oral and written communication skills; strong presentation and facilitation skills to effectively inform key updates and issues to executive leadership Required Qualifications: Graduate degree in life sciences, chemistry, or related field with 15+ years' experience in the Biotech/pharma industry (advanced degree preferred) A natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment Experienced leader and scientist with a strong background in discovery and development of novel formulations, including lipid nanoparticles (LNP) vehicles. Available to travel if/when needed
Our Cambridge, MA client is a biopharmaceutical company that is focused on the discovery, development and commercialization of therapeutics for genetically defined diseases. They have engaged us to find an Associate Director, R&D Communications. This person must be able to work onsite 2 days/week. They are consistently ranked a top employer around the world, including Large Employer by Boston Globe Top Places to Work, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies by Newsweek and many others! In this role, you will help shape and execute strategic communications that advance the scientific narrative, awareness, and thought leadership of the company's industry-leading platform and exciting pipeline. This role will be responsible for leading internal and external communications of the President and the R&D Leadership team. Primary Responsibilities Drive and execute communications plans and media strategies that drive understanding of the company's platform to elevate visibility. Support the R&D Leadership Team with developing content for internal channels, including town hall presentations, talking points, videos, and blogs to boost engagement. Enhance executive visibility and R&D Thought Leadership with earned media and byline opportunities. Serve as a liaison for media outlets. Write Q&As, messages, press releases, and presentations in support of pipeline milestones. Collaborate with Creative team to develop engaging content for digital and social channels. Qualifications Minimum of 8+ years of experience required from a biotech or pharmaceutical company - or an agency (comms or ad) that supports clients in the industry. Exceptional writing and editing skills; strong oral communications skills and ability to convey complex science for a variety of audiences. Ability to deliver products that engage, excite, and motivate audiences. Ability to interact with all levels of the company top to bottom, including senior management. Bachelor's degree and advanced degrees required (e.g., PharmD/PhD/MPH).
05/21/2023
Full time
Our Cambridge, MA client is a biopharmaceutical company that is focused on the discovery, development and commercialization of therapeutics for genetically defined diseases. They have engaged us to find an Associate Director, R&D Communications. This person must be able to work onsite 2 days/week. They are consistently ranked a top employer around the world, including Large Employer by Boston Globe Top Places to Work, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies by Newsweek and many others! In this role, you will help shape and execute strategic communications that advance the scientific narrative, awareness, and thought leadership of the company's industry-leading platform and exciting pipeline. This role will be responsible for leading internal and external communications of the President and the R&D Leadership team. Primary Responsibilities Drive and execute communications plans and media strategies that drive understanding of the company's platform to elevate visibility. Support the R&D Leadership Team with developing content for internal channels, including town hall presentations, talking points, videos, and blogs to boost engagement. Enhance executive visibility and R&D Thought Leadership with earned media and byline opportunities. Serve as a liaison for media outlets. Write Q&As, messages, press releases, and presentations in support of pipeline milestones. Collaborate with Creative team to develop engaging content for digital and social channels. Qualifications Minimum of 8+ years of experience required from a biotech or pharmaceutical company - or an agency (comms or ad) that supports clients in the industry. Exceptional writing and editing skills; strong oral communications skills and ability to convey complex science for a variety of audiences. Ability to deliver products that engage, excite, and motivate audiences. Ability to interact with all levels of the company top to bottom, including senior management. Bachelor's degree and advanced degrees required (e.g., PharmD/PhD/MPH).
Start your career with Premium. Merchandising Lead and Trainer General Information Location: CAMBRIDGE, Massachusetts, 02140 Ref #: 35657 Function: Merchandising Employment Duration: Part-time Description and Requirements As one of Premium's vital merchandising lead and trainers, you'll ensure success of Premium's field team by connecting merchandisers to our culture and providing the necessary resources to achieve client objectives in retail stores. Your efforts training merchandisers and executing merchandising activities in your area will ensure merchandising excellence for Premium clients. What's in it for you? Flexibility in scheduling your work hours. Ability to influence field team success through training. Opportunity to take the lead on projects and directly impact client success. A clear-cut path for advancing your career within Premium. Quarterly bonus opportunity. Health plan options including no-copay telemedicine, regardless of hours worked. What will you do? Ensure execution of key merchandising objectives for Premium clients by effectively training, mentoring and providing feedback to merchandisers in your assigned market. Assist merchandising team members in your market in order to work through challenges and obstacles. Provide project leadership and merchandising coverage across retail stores to ensure we get the job done for clients. Complete specialized training and certifications. Partner directly with store management and associates to ensure they understand and are aware of the activities merchandisers are performing in their location. Lead by example when reporting work to demonstrate success and provide visibility of our efforts to the Premium clients. How will you succeed? Sharing your expertise and being passionate about training other and ensuring merchandisers understand how to succeed. Looking for creative ways to solve problems. Dedicating yourself to continually improving your stores and the success of other merchandisers. Using your awesome communication skills and staying organized. Building strong relationships with field team members, Premium management and retail partners within your assigned area(s). So, are _you_ Premium's next Merchandising Lead and Trainer _?_ For more information about our merchandising team, visit Equal Opportunity Employer (Disabled, Veteran) Under applicable requirements, such as the San Francisco FCO and the Los Angeles FCHIO, we consider for employment qualified applicants with arrest and conviction records or criminal histories E-Verify Employer
05/21/2023
Full time
Start your career with Premium. Merchandising Lead and Trainer General Information Location: CAMBRIDGE, Massachusetts, 02140 Ref #: 35657 Function: Merchandising Employment Duration: Part-time Description and Requirements As one of Premium's vital merchandising lead and trainers, you'll ensure success of Premium's field team by connecting merchandisers to our culture and providing the necessary resources to achieve client objectives in retail stores. Your efforts training merchandisers and executing merchandising activities in your area will ensure merchandising excellence for Premium clients. What's in it for you? Flexibility in scheduling your work hours. Ability to influence field team success through training. Opportunity to take the lead on projects and directly impact client success. A clear-cut path for advancing your career within Premium. Quarterly bonus opportunity. Health plan options including no-copay telemedicine, regardless of hours worked. What will you do? Ensure execution of key merchandising objectives for Premium clients by effectively training, mentoring and providing feedback to merchandisers in your assigned market. Assist merchandising team members in your market in order to work through challenges and obstacles. Provide project leadership and merchandising coverage across retail stores to ensure we get the job done for clients. Complete specialized training and certifications. Partner directly with store management and associates to ensure they understand and are aware of the activities merchandisers are performing in their location. Lead by example when reporting work to demonstrate success and provide visibility of our efforts to the Premium clients. How will you succeed? Sharing your expertise and being passionate about training other and ensuring merchandisers understand how to succeed. Looking for creative ways to solve problems. Dedicating yourself to continually improving your stores and the success of other merchandisers. Using your awesome communication skills and staying organized. Building strong relationships with field team members, Premium management and retail partners within your assigned area(s). So, are _you_ Premium's next Merchandising Lead and Trainer _?_ For more information about our merchandising team, visit Equal Opportunity Employer (Disabled, Veteran) Under applicable requirements, such as the San Francisco FCO and the Los Angeles FCHIO, we consider for employment qualified applicants with arrest and conviction records or criminal histories E-Verify Employer
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Description: The Takeda Enterprise Cloud platform is also a complex product line, offering enabling and self-service capabilities to its consumers. Product Line Management is the function responsible for defining the desirable, viable, feasible, and sustainable solutions to meet platform consumer needs while supporting ongoing development across the product life cycle. This role has primary accountability for leading demand-based platform roadmap development including product line strategy and planning - as well as working with a team to orchestrate the development, testing, and release of new, enhanced, and changed products within the "Product Line" to meet demand. Product line management for the platform operates a quarterly planning cycle based on the principles of the Scaled Agile Framework. Key Responsibilities: Understand DD&T business goals and strategies, existing Cloud Platform capabilities, enterprise DD&T strategy, and available DD&T products and/or services. Understand platform end-user needs and behaviors. Understand, anticipate, and influence demand for DD&T products and services. Key interactions: Align on Outcomes: Work directly with business owners and platform customers to define outcomes and prioritize based on value, cost of delay, and other factors. Evolve the solution: Work directly with product owners and the development teams to orchestrate delivery of the right value to the business in quarterly planning increments Steer the Agile Release Train (ART): work with the RTE's and System Architects to orchestrate delivery and make appropriate tradeoff decisions during PI execution Inspect and Adapt: Continuously improve the planning and development process in concert with the overall team Product Line Strategy & Planning: Lead generation, capture, and screening of Cloud Platform innovation ideas. Guide product line development teams on definition of what Cloud Platform enhancements, or new products, to offer customers based on their goals, needs, and strategies. Coach product teams and customers through analysis and prioritization of innovation ideas, new product concepts/pilots, product changes/enhancements (e.g., Investment Portfolios, Product Roadmaps). Product Line Architecture: Work closely with the Platform Architecture & Engineering leader and with Demand Management to: Ensure Platform Managers/Product Owners understand DD&T goals, strategies, and value streams Make sure Platform Consumers understand existing and future Cloud Platform products and services capabilities, and prioritize use of existing or planned capabilities over unplanned capabilities Ensure platform architecture and engineering teams design and/or assemble the right or most valuable features and functions in quarterly Program Increments to meet customer needs when defining product architectures. Product Line Leadership: Manage relationship between platform team, and BU/BF consumers along with Demand Managers Work with a group of Release Train Engineers and Scrum Masters to orchestrate and monitor the delivery of committed quarterly value across one or more Agile Release Trains (ARTs) Make sure product teams use approved GDT tools and methods to plan and coordinate technical product and/or service design, development, testing, deployments, and releases for all Cloud Platform products Confirm product teams consider and improve, the customer/user experience when designing and releasing new, enhance, or changed products in the cloud product line Along with Platform Architecture & Engineering, plan and oversee testing, prototyping, and/or incubation of advanced technologies within the Cloud Product Line Ensure teams plan and manage releases of new, enhanced, or changed products and/or services that meet customer and end-user needs Ensure appropriate feedback loops, customer satisfaction surveys, and service awareness / adoption strategies are in place Critical Knowledge and Skills: Customer Relationship Management General knowledge of GDT Shared Platforms and Standards Excellent presentation and communication skills Scaled Agile Framework 5/6 certification (PO/PM) Cloud (AWS) certification demonstrating technical domain knowledge in relevant IaaS and PaaS services Strong demonstrated ability to leverage Jira, Confluence and similar tools in product line planning as well as quarterly execution Ability to guide demand intake to outcomes-based discussions Capability to lead quarterly PI Planning Ability to manage a team of RTEs and Scrum Masters through influence as well as positional authority Developing & Implementing Strategies Directing & Influencing Others Agile SDLC, preferably the Takeda Agile SDLC, and DevSecOps Tools & Methodologies such as CI/CD EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Cambridge, MA CHE - Switzerland Remote Worker Type Employee Worker Sub-Type Regular Time Type Full time
05/20/2023
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Description: The Takeda Enterprise Cloud platform is also a complex product line, offering enabling and self-service capabilities to its consumers. Product Line Management is the function responsible for defining the desirable, viable, feasible, and sustainable solutions to meet platform consumer needs while supporting ongoing development across the product life cycle. This role has primary accountability for leading demand-based platform roadmap development including product line strategy and planning - as well as working with a team to orchestrate the development, testing, and release of new, enhanced, and changed products within the "Product Line" to meet demand. Product line management for the platform operates a quarterly planning cycle based on the principles of the Scaled Agile Framework. Key Responsibilities: Understand DD&T business goals and strategies, existing Cloud Platform capabilities, enterprise DD&T strategy, and available DD&T products and/or services. Understand platform end-user needs and behaviors. Understand, anticipate, and influence demand for DD&T products and services. Key interactions: Align on Outcomes: Work directly with business owners and platform customers to define outcomes and prioritize based on value, cost of delay, and other factors. Evolve the solution: Work directly with product owners and the development teams to orchestrate delivery of the right value to the business in quarterly planning increments Steer the Agile Release Train (ART): work with the RTE's and System Architects to orchestrate delivery and make appropriate tradeoff decisions during PI execution Inspect and Adapt: Continuously improve the planning and development process in concert with the overall team Product Line Strategy & Planning: Lead generation, capture, and screening of Cloud Platform innovation ideas. Guide product line development teams on definition of what Cloud Platform enhancements, or new products, to offer customers based on their goals, needs, and strategies. Coach product teams and customers through analysis and prioritization of innovation ideas, new product concepts/pilots, product changes/enhancements (e.g., Investment Portfolios, Product Roadmaps). Product Line Architecture: Work closely with the Platform Architecture & Engineering leader and with Demand Management to: Ensure Platform Managers/Product Owners understand DD&T goals, strategies, and value streams Make sure Platform Consumers understand existing and future Cloud Platform products and services capabilities, and prioritize use of existing or planned capabilities over unplanned capabilities Ensure platform architecture and engineering teams design and/or assemble the right or most valuable features and functions in quarterly Program Increments to meet customer needs when defining product architectures. Product Line Leadership: Manage relationship between platform team, and BU/BF consumers along with Demand Managers Work with a group of Release Train Engineers and Scrum Masters to orchestrate and monitor the delivery of committed quarterly value across one or more Agile Release Trains (ARTs) Make sure product teams use approved GDT tools and methods to plan and coordinate technical product and/or service design, development, testing, deployments, and releases for all Cloud Platform products Confirm product teams consider and improve, the customer/user experience when designing and releasing new, enhance, or changed products in the cloud product line Along with Platform Architecture & Engineering, plan and oversee testing, prototyping, and/or incubation of advanced technologies within the Cloud Product Line Ensure teams plan and manage releases of new, enhanced, or changed products and/or services that meet customer and end-user needs Ensure appropriate feedback loops, customer satisfaction surveys, and service awareness / adoption strategies are in place Critical Knowledge and Skills: Customer Relationship Management General knowledge of GDT Shared Platforms and Standards Excellent presentation and communication skills Scaled Agile Framework 5/6 certification (PO/PM) Cloud (AWS) certification demonstrating technical domain knowledge in relevant IaaS and PaaS services Strong demonstrated ability to leverage Jira, Confluence and similar tools in product line planning as well as quarterly execution Ability to guide demand intake to outcomes-based discussions Capability to lead quarterly PI Planning Ability to manage a team of RTEs and Scrum Masters through influence as well as positional authority Developing & Implementing Strategies Directing & Influencing Others Agile SDLC, preferably the Takeda Agile SDLC, and DevSecOps Tools & Methodologies such as CI/CD EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Cambridge, MA CHE - Switzerland Remote Worker Type Employee Worker Sub-Type Regular Time Type Full time
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Director Medical Affairs Oncology, Solid Tumors Company: Ipsen Biopharmaceuticals Inc. Job Description: Director Medical Affairs Oncology, Solid Tumors Company Profile Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs. We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our Cambridge, MA, Basking Ridge, NJ and Toronto, Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations. Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve. Position Summary The Director, Medical Affairs, Oncology Solid Tumors will oversee all US medical affairs activities related to metastatic pancreatic cancer. The Medical Director is responsible for driving the medical strategies for the overall US Medical Affairs plan, including cross collaboration with key internal partners as well as managing relationships with key opinion leaders. This role works closely with the therapeutic area lead/head and indication leads to provide strategic medical insight and operational input into core medical affairs activities. Responsibilities Drives the strategy from an Oncology brand medical perspective across the solid tumor area, shaping tumor level strategy and priorities Will work across solid tumor areas at a brand/asset level to ensure tumor and brand strategies align to ensure the maximum medical impact Leads the development and execution of the asset specific medical tactical plan aligned to strategy including evidence generation, scientific communications, interactions with external experts, and patient centric activities Accountable for implementing external scientific collaboration strategies to address education gaps and establish confidence in our brands and their impact on patients Works with the therapeutic area lead, engaging and influencing in market medical teams and prioritized launch market teams to ensure that relevant market insights are used to inform product development, brand strategies and launch plans Engage with multiple senior stakeholders to provide insights, data, launch plans and recommendations that will influence brand decisions Represent Ipsen at key external events, congresses, scientific symposia's etc. and will liaise with external stakeholders to enhance the scientific and clinical understanding of brand/asset in relation to the tumor/tumor type and clinical landscape Partners closely with colleagues in the Markets, Medical (Publications, Medical Information, RWE, Medical Excellence), Marketing, Regulatory Affairs, Payer, Health Outcomes and other key functions, and helps build alignment on key initiatives including optimal approach to data generation, communication and supporting access Ensures that all Medical and business activities are carried out in compliance with Ipsen standards, standard operating procedures and external regulations Essential requirements Minimum doctorate degree in a scientific discipline or equivalent medical/scientific qualifications and/or significant industry and/or therapeutic experience (MD, PhD, or PharmD preferred) Minimum 5 years leadership/specialized experience within pharma/life sciences (e.g., significant clinical/academic/medical affairs agency roles/organizations) Able to evaluate, interpret and present highly complex data for a series of studies Ability to lead cross functional working groups and teams with a complex matrix organization Experience with financial and resource planning and management is essential Ability to influence strategically and persuade tactfully, to obtain desired outcomes while maintaining effective, positive organizational relationships Excellent presentation and communication skills with the ability to meet the needs of scientific, commercial needs Experience in product launch and life cycle management in oncology Oncology Solid Tumor experience, GI focus Product launch experience IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
05/20/2023
Full time
Title: Director Medical Affairs Oncology, Solid Tumors Company: Ipsen Biopharmaceuticals Inc. Job Description: Director Medical Affairs Oncology, Solid Tumors Company Profile Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs. We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our Cambridge, MA, Basking Ridge, NJ and Toronto, Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations. Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve. Position Summary The Director, Medical Affairs, Oncology Solid Tumors will oversee all US medical affairs activities related to metastatic pancreatic cancer. The Medical Director is responsible for driving the medical strategies for the overall US Medical Affairs plan, including cross collaboration with key internal partners as well as managing relationships with key opinion leaders. This role works closely with the therapeutic area lead/head and indication leads to provide strategic medical insight and operational input into core medical affairs activities. Responsibilities Drives the strategy from an Oncology brand medical perspective across the solid tumor area, shaping tumor level strategy and priorities Will work across solid tumor areas at a brand/asset level to ensure tumor and brand strategies align to ensure the maximum medical impact Leads the development and execution of the asset specific medical tactical plan aligned to strategy including evidence generation, scientific communications, interactions with external experts, and patient centric activities Accountable for implementing external scientific collaboration strategies to address education gaps and establish confidence in our brands and their impact on patients Works with the therapeutic area lead, engaging and influencing in market medical teams and prioritized launch market teams to ensure that relevant market insights are used to inform product development, brand strategies and launch plans Engage with multiple senior stakeholders to provide insights, data, launch plans and recommendations that will influence brand decisions Represent Ipsen at key external events, congresses, scientific symposia's etc. and will liaise with external stakeholders to enhance the scientific and clinical understanding of brand/asset in relation to the tumor/tumor type and clinical landscape Partners closely with colleagues in the Markets, Medical (Publications, Medical Information, RWE, Medical Excellence), Marketing, Regulatory Affairs, Payer, Health Outcomes and other key functions, and helps build alignment on key initiatives including optimal approach to data generation, communication and supporting access Ensures that all Medical and business activities are carried out in compliance with Ipsen standards, standard operating procedures and external regulations Essential requirements Minimum doctorate degree in a scientific discipline or equivalent medical/scientific qualifications and/or significant industry and/or therapeutic experience (MD, PhD, or PharmD preferred) Minimum 5 years leadership/specialized experience within pharma/life sciences (e.g., significant clinical/academic/medical affairs agency roles/organizations) Able to evaluate, interpret and present highly complex data for a series of studies Ability to lead cross functional working groups and teams with a complex matrix organization Experience with financial and resource planning and management is essential Ability to influence strategically and persuade tactfully, to obtain desired outcomes while maintaining effective, positive organizational relationships Excellent presentation and communication skills with the ability to meet the needs of scientific, commercial needs Experience in product launch and life cycle management in oncology Oncology Solid Tumor experience, GI focus Product launch experience IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Scope of Work: Ongoing locum opening Hospital based setting 100% CRNA Supervision Monday thru Friday plus share in call Travel & Lodging Compensation Paid Weekly A rated Malpractice Expedited Credentialing Assistance Dates: New contract! Starting July 1 Ongoing About the Job: (3 hospitals) 6 MDs & 6-7 CRNAs 1:3 supervision EPIC EMR G/I and General 1300 OB No hearts, no trauma No OB Endo Scheduling: M- F plus share in call 1:3 AN in-house weekend call (Fri- 3p-7a, $4k, Sat 7a-7a,$6k, Sun 7a-3p $2k) AN Sunday night beeper call- 3p-7a AN- weeknight beeper call- 7p-7a Rates: $350/hour plus $25/hour bonus $370/hour over 40 or any call back hours plus $25/hour bonus $370 beeper fee from 7p-7a AN in-house weekend call (Fri- 3p-7a, $4k, Sat 7a-7a,$6k, Sun 7a-3p $2k) 40 hour weekly guarantee Plus airfare, rental car or mileage & hotel. No guaranteed hours on holiday weeks or if provider requests off. Other Info:
05/20/2023
Full time
Scope of Work: Ongoing locum opening Hospital based setting 100% CRNA Supervision Monday thru Friday plus share in call Travel & Lodging Compensation Paid Weekly A rated Malpractice Expedited Credentialing Assistance Dates: New contract! Starting July 1 Ongoing About the Job: (3 hospitals) 6 MDs & 6-7 CRNAs 1:3 supervision EPIC EMR G/I and General 1300 OB No hearts, no trauma No OB Endo Scheduling: M- F plus share in call 1:3 AN in-house weekend call (Fri- 3p-7a, $4k, Sat 7a-7a,$6k, Sun 7a-3p $2k) AN Sunday night beeper call- 3p-7a AN- weeknight beeper call- 7p-7a Rates: $350/hour plus $25/hour bonus $370/hour over 40 or any call back hours plus $25/hour bonus $370 beeper fee from 7p-7a AN in-house weekend call (Fri- 3p-7a, $4k, Sat 7a-7a,$6k, Sun 7a-3p $2k) 40 hour weekly guarantee Plus airfare, rental car or mileage & hotel. No guaranteed hours on holiday weeks or if provider requests off. Other Info:
MI/ Panjiva is a data-driven technology company that uses machine learning to extract insights from global trade data. This unstructured data describes the behavior of the many real-world entities such as companies, products, and ports that make up international trade . Panjiva's data help s power the decisions of our thousands of clients, including Fortune 500 companies, hedge funds, and logistics providers, in additio n to universities, government agencies, and NGO s . The Data Science team creates state of the art model s that enable the P anjiva platform . We work with h ighly complex , often unstructured, data f rom disparate sources , in many different languages. We use a wide variety of ML and AI tech niques but have a special focus on NLP and Time S eries. Our work is core to the value Panjiva provides our customers. As an example, we built a custom text classification model that handles rare terms ( e.g. Aluminum zirconium tetrachlorohydre x gl y ), multiple languages, and misspellings that traditional language embedding techniques struggle with. This model allows our customers to search our data by industry standard product categories, rather than relying on text-based searches. We are seeking talented data scientist s to join our team. Strong candidates are able to leverage a wide array of machine learning and statistical techniques and to dig deep into our data with an eye for detail. You wi ll collaborate with a variety of teams across the company (analy tics , engineering, product, and commercial) in unlocking value from our data. Responsibilities: Large-scale clustering entity resolution and fuzzy text matching Document classification via natural language processing Anomaly detection, trend prediction, and modeling on the global supply chain network Identification and evaluation of novel, complementary data s ets Extracting insights from messy, usually un-labeled, data cross multiple languages Work and speak with customers to build solutions catered to their needs What We're Looking For: Qualifications: 3-4+ years of relevant Data Science or Machine Learning Engineer experience Thorough understanding of statistical, analytical, and traditional machine-learning techniques Thorough understanding of NLP techniques including deep learning Track record of providing valuable insights into large, multidimensional datasets Strong coding skills in Python or another scientific language. Experience performing data analysis, modeling, and generating visualizations Comfort working with relational databases and SQL Strong ability to communicate and visualize findings Advanced degree in a quantitative field, or equivalent experience Nice-to-Haves: Background in time series or forecasting. Background in information retrieval . Comfort with software development standard practices, including version control, unit testing, and code review Experience deploying and maintaining models in a production environment Some exposure to Ruby Domain knowledge on international economics and trade S&P Global states that the anticipated base salary range for this position is $70,000 to $139,000. Base salary ranges may vary by geographic location. In addition to base compensation, this role is eligible for an annual incentive plan. This role is eligible to receive additional S&P Global benefits. For more information on the benefits we provide to our employees, visit S&P Benefits . At S&P Global Market Intelligence, we know that not all information is important-some of it is vital. Accurate, deep and insightful. We integrate financial and industry data, research and news into tools that help track performance, generate alpha, identify investment ideas, understand competitive and industry dynamics, perform valuation and assess credit risk. Investment professionals, government agencies, corporations and universities globally can gain the intelligence essential to making business and financial decisions with conviction. S&P Global Market Intelligence is a division of S&P Global (NYSE: SPGI), which provides essential intelligence for individuals, companies and governments to make decisions with confidence. For more information, visit . - Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to: and your request will be forwarded to the appropriate person. US Candidates Only: The EEO is the Law Poster describes discrimination protections under federal law. - 20 - Professional (EEO-2 Job Categories-United States of America), IFTECH202.2 - Middle Professional Tier II (EEO Job Group), SWP Priority - Ratings - (Strategic Workforce Planning) Job ID: 275628 Posted On: 2023-05-18 Location: Cambridge, Massachusetts, United States
05/20/2023
Full time
MI/ Panjiva is a data-driven technology company that uses machine learning to extract insights from global trade data. This unstructured data describes the behavior of the many real-world entities such as companies, products, and ports that make up international trade . Panjiva's data help s power the decisions of our thousands of clients, including Fortune 500 companies, hedge funds, and logistics providers, in additio n to universities, government agencies, and NGO s . The Data Science team creates state of the art model s that enable the P anjiva platform . We work with h ighly complex , often unstructured, data f rom disparate sources , in many different languages. We use a wide variety of ML and AI tech niques but have a special focus on NLP and Time S eries. Our work is core to the value Panjiva provides our customers. As an example, we built a custom text classification model that handles rare terms ( e.g. Aluminum zirconium tetrachlorohydre x gl y ), multiple languages, and misspellings that traditional language embedding techniques struggle with. This model allows our customers to search our data by industry standard product categories, rather than relying on text-based searches. We are seeking talented data scientist s to join our team. Strong candidates are able to leverage a wide array of machine learning and statistical techniques and to dig deep into our data with an eye for detail. You wi ll collaborate with a variety of teams across the company (analy tics , engineering, product, and commercial) in unlocking value from our data. Responsibilities: Large-scale clustering entity resolution and fuzzy text matching Document classification via natural language processing Anomaly detection, trend prediction, and modeling on the global supply chain network Identification and evaluation of novel, complementary data s ets Extracting insights from messy, usually un-labeled, data cross multiple languages Work and speak with customers to build solutions catered to their needs What We're Looking For: Qualifications: 3-4+ years of relevant Data Science or Machine Learning Engineer experience Thorough understanding of statistical, analytical, and traditional machine-learning techniques Thorough understanding of NLP techniques including deep learning Track record of providing valuable insights into large, multidimensional datasets Strong coding skills in Python or another scientific language. Experience performing data analysis, modeling, and generating visualizations Comfort working with relational databases and SQL Strong ability to communicate and visualize findings Advanced degree in a quantitative field, or equivalent experience Nice-to-Haves: Background in time series or forecasting. Background in information retrieval . Comfort with software development standard practices, including version control, unit testing, and code review Experience deploying and maintaining models in a production environment Some exposure to Ruby Domain knowledge on international economics and trade S&P Global states that the anticipated base salary range for this position is $70,000 to $139,000. Base salary ranges may vary by geographic location. In addition to base compensation, this role is eligible for an annual incentive plan. This role is eligible to receive additional S&P Global benefits. For more information on the benefits we provide to our employees, visit S&P Benefits . At S&P Global Market Intelligence, we know that not all information is important-some of it is vital. Accurate, deep and insightful. We integrate financial and industry data, research and news into tools that help track performance, generate alpha, identify investment ideas, understand competitive and industry dynamics, perform valuation and assess credit risk. Investment professionals, government agencies, corporations and universities globally can gain the intelligence essential to making business and financial decisions with conviction. S&P Global Market Intelligence is a division of S&P Global (NYSE: SPGI), which provides essential intelligence for individuals, companies and governments to make decisions with confidence. For more information, visit . - Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to: and your request will be forwarded to the appropriate person. US Candidates Only: The EEO is the Law Poster describes discrimination protections under federal law. - 20 - Professional (EEO-2 Job Categories-United States of America), IFTECH202.2 - Middle Professional Tier II (EEO Job Group), SWP Priority - Ratings - (Strategic Workforce Planning) Job ID: 275628 Posted On: 2023-05-18 Location: Cambridge, Massachusetts, United States
Communications Manager Paving the future of cancer research requires creative and driven individuals who think differently about solutions to fundamental challenges blocking progress for cancer patients. Break Through Cancer is a new type of research foundation whose mission is to promote and support inter-institutional, collaborative cancer research in order to better understand and treat the most intractable forms of cancer. By aligning research teams across five leading cancer institutions, Break Through Cancer is creating frameworks to make inter-institutional cancer research frictionless and impactful. Break Through Cancer funded TeamLabs in glioblastoma, acute myelogenous leukemia, ovarian, and pancreas cancers are creating new approaches to revolutionize cancer interception, accelerate the pace of drug approval by bringing the worlds of preclinical and clinical science together to support learning in patients, incentivize radical collaboration between academic institutions and between academia and industry, and invest in software and technologies that will enhance user experiences. Break Through Cancer seeks a highly motivated, experienced Communications Manager with a scientific writing background to join our dynamic team. The successful candidate will be responsible for developing and implementing comprehensive communication strategies to advance our mission to intercept and cure the deadliest cancers. The Communications Manager will report to the Chief Communications Officer. The position is located in Cambridge, MA, and employees are expected to be onsite a minimum of 3-4 days per week. Primary Responsibilities Develop and execute comprehensive communication strategies to promote Break Through Cancer's research initiatives, programs, and the scientists who work in our funded TeamLabs; Write and edit scientific content for various publications, including scientific journals, annual reports, and newsletters, as well as development and collateral material Develop and implement digital and social media campaigns to promote Break Through Cancer's initiatives and engage with key stakeholders Develop and manage relationships with key stakeholders, including scientists, clinicians, and staff; Manage project timelines, budgets, and deliverables to ensure timely completion of communications projects; Collaborate with other Break Through Cancer teams, including philanthropy and events, to ensure a cohesive, integrated approach to communications; Ensure all communications materials are accurate, clear, and consistent with Break Through Cancer's brand and messaging; and Keep up-to-date with the latest developments in cancer research and communicate findings to relevant stakeholders. Support the Chief Communications Officer and other leadership on projects important to the mission of Break Through Cancer Qualifications Scientific writing background required Bachelor's degree 8+ years of experience in communications or marketing in a scientific or healthcare-related field Strong project management skills, with the ability to manage multiple projects simultaneously Flexible work style, with the ability to work independently and collaboratively in a fast-paced environment Attention to detail and ability to work within tight timelines Strong writing, editing, and interpersonal skills Knowledge of cancer research and the scientific community is a plus To apply for the Break Through Cancer Communications Manager position, please submit a cover letter and CV to . Break Through Cancer is committed to providing equal opportunities in employment and prohibits discrimination and harassment of any kind. We treat our colleagues and applicants fairly and respectfully. We seek to employ people with skill and integrity, and provide them with the means to develop professionally. We hire without regard to race, color, religion, creed, citizenship, national origin, age, sex, gender, pregnancy, gender identity/expression, sexual orientation, marital status, disability (including neurodiversity), genetic information, veteran status, and any other legally protected group, in accordance with applicable federal, state, or local law.
05/20/2023
Full time
Communications Manager Paving the future of cancer research requires creative and driven individuals who think differently about solutions to fundamental challenges blocking progress for cancer patients. Break Through Cancer is a new type of research foundation whose mission is to promote and support inter-institutional, collaborative cancer research in order to better understand and treat the most intractable forms of cancer. By aligning research teams across five leading cancer institutions, Break Through Cancer is creating frameworks to make inter-institutional cancer research frictionless and impactful. Break Through Cancer funded TeamLabs in glioblastoma, acute myelogenous leukemia, ovarian, and pancreas cancers are creating new approaches to revolutionize cancer interception, accelerate the pace of drug approval by bringing the worlds of preclinical and clinical science together to support learning in patients, incentivize radical collaboration between academic institutions and between academia and industry, and invest in software and technologies that will enhance user experiences. Break Through Cancer seeks a highly motivated, experienced Communications Manager with a scientific writing background to join our dynamic team. The successful candidate will be responsible for developing and implementing comprehensive communication strategies to advance our mission to intercept and cure the deadliest cancers. The Communications Manager will report to the Chief Communications Officer. The position is located in Cambridge, MA, and employees are expected to be onsite a minimum of 3-4 days per week. Primary Responsibilities Develop and execute comprehensive communication strategies to promote Break Through Cancer's research initiatives, programs, and the scientists who work in our funded TeamLabs; Write and edit scientific content for various publications, including scientific journals, annual reports, and newsletters, as well as development and collateral material Develop and implement digital and social media campaigns to promote Break Through Cancer's initiatives and engage with key stakeholders Develop and manage relationships with key stakeholders, including scientists, clinicians, and staff; Manage project timelines, budgets, and deliverables to ensure timely completion of communications projects; Collaborate with other Break Through Cancer teams, including philanthropy and events, to ensure a cohesive, integrated approach to communications; Ensure all communications materials are accurate, clear, and consistent with Break Through Cancer's brand and messaging; and Keep up-to-date with the latest developments in cancer research and communicate findings to relevant stakeholders. Support the Chief Communications Officer and other leadership on projects important to the mission of Break Through Cancer Qualifications Scientific writing background required Bachelor's degree 8+ years of experience in communications or marketing in a scientific or healthcare-related field Strong project management skills, with the ability to manage multiple projects simultaneously Flexible work style, with the ability to work independently and collaboratively in a fast-paced environment Attention to detail and ability to work within tight timelines Strong writing, editing, and interpersonal skills Knowledge of cancer research and the scientific community is a plus To apply for the Break Through Cancer Communications Manager position, please submit a cover letter and CV to . Break Through Cancer is committed to providing equal opportunities in employment and prohibits discrimination and harassment of any kind. We treat our colleagues and applicants fairly and respectfully. We seek to employ people with skill and integrity, and provide them with the means to develop professionally. We hire without regard to race, color, religion, creed, citizenship, national origin, age, sex, gender, pregnancy, gender identity/expression, sexual orientation, marital status, disability (including neurodiversity), genetic information, veteran status, and any other legally protected group, in accordance with applicable federal, state, or local law.
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: Associate Director, Global Regulatory Affairs, Neuroscience Company: Ipsen Bioscience, Inc. Job Description: The Associate Director, Global Regulatory Affairs, Neuroscience is accountable for the development, flawless execution and implementation of regulatory strategies and activities for the Neuroscience portfolio. The AD, GRA, Neuroscience will work cross functionally with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of our Neuroscience products. Main Responsibilities Accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components for assigned region or worldwide. Provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects. Act as the interface between the R&D/Franchise/Operations and GRA on all regulatory issues relevant to Development and Product Maintenance activities within the Neuroscience portfolio Ensure the development and flawless execution of regulatory strategies for the Neuroscience portfolio and all of its components (both development and marketed products) globally Responsible for Regulatory Intelligence and to identify and then communicate the implication of upcoming trends that may impact the business. Responsible for having a broad perspective on external influencing issues as he/she may participate in external influencing activities with health authorities or trade associations, particularly those that would benefit from a broad perspective on Ipsen regulatory policy. Lead operational excellence initiatives within Global Regulatory Affairs Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. Ensure timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.). Education, Experience and Qualifications BA/BS or equivalent in a scientific or related discipline is required; advanced degree is a plus Significant experience in the pharmaceutical industry, including at least 7+ years within Regulatory Affairs. Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies. Track record of building excellent relationships with the FDA Knowledge of EU and Asia Pacific (mainly China and Japan) regulatory environment would be a strong plus. Knowledge of medical device / drug device combination regulations would be a plus. Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of agencies and ensuring compliance with regulations in all regions Ability to distil key information from complex and extensive sources and present the information in a constructive way. Solid project management skills with proven ability to develop and implement longer term plans or delivery of large-scale projects. Consistent ability to foster strong matrix working with a proven track record of facilitating groups of individuals to work together on innovative regulatory solutions. Strong interpersonal and negotiation skills with a proven ability to build strong networks, both internally and externally Proven capability to influence decision makers both internally and externally Proven ability to lead change and communicate difficult messages effectively Excellent written and oral communication skills and delivers all communication with clarity and impact. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
05/20/2023
Full time
Title: Associate Director, Global Regulatory Affairs, Neuroscience Company: Ipsen Bioscience, Inc. Job Description: The Associate Director, Global Regulatory Affairs, Neuroscience is accountable for the development, flawless execution and implementation of regulatory strategies and activities for the Neuroscience portfolio. The AD, GRA, Neuroscience will work cross functionally with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of our Neuroscience products. Main Responsibilities Accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components for assigned region or worldwide. Provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects. Act as the interface between the R&D/Franchise/Operations and GRA on all regulatory issues relevant to Development and Product Maintenance activities within the Neuroscience portfolio Ensure the development and flawless execution of regulatory strategies for the Neuroscience portfolio and all of its components (both development and marketed products) globally Responsible for Regulatory Intelligence and to identify and then communicate the implication of upcoming trends that may impact the business. Responsible for having a broad perspective on external influencing issues as he/she may participate in external influencing activities with health authorities or trade associations, particularly those that would benefit from a broad perspective on Ipsen regulatory policy. Lead operational excellence initiatives within Global Regulatory Affairs Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas. Ensure timely and accurate information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.). Education, Experience and Qualifications BA/BS or equivalent in a scientific or related discipline is required; advanced degree is a plus Significant experience in the pharmaceutical industry, including at least 7+ years within Regulatory Affairs. Proven experience of drug development and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies. Track record of building excellent relationships with the FDA Knowledge of EU and Asia Pacific (mainly China and Japan) regulatory environment would be a strong plus. Knowledge of medical device / drug device combination regulations would be a plus. Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of agencies and ensuring compliance with regulations in all regions Ability to distil key information from complex and extensive sources and present the information in a constructive way. Solid project management skills with proven ability to develop and implement longer term plans or delivery of large-scale projects. Consistent ability to foster strong matrix working with a proven track record of facilitating groups of individuals to work together on innovative regulatory solutions. Strong interpersonal and negotiation skills with a proven ability to build strong networks, both internally and externally Proven capability to influence decision makers both internally and externally Proven ability to lead change and communicate difficult messages effectively Excellent written and oral communication skills and delivers all communication with clarity and impact. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
General Scope and Summary SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for broad executive and departmental administrative support. We are actively seeking a dynamic, proactive Executive Assistant Consultant. In this position, you will be an integral contributor to Digital & Enterprise Capabilities (DEC), acting as the organizational and communication hub for the department and working collaboratively with other departments. This role is ideal for a self-starter that will be able to anticipate the needs of the department and will be successfully working autonomously. Roles and Responsibilities Coordinate internal and external calendar, meetings, schedule, travel arrangements, and expense reports and prepare necessary materials. Consult with leaders and team members as needed to solicit information, provide critical updates, and coordinate information and priorities. Exercise tact, diplomacy, and discretion in written and verbal communications. Plan, organize, and compile data. Analyze needs and problems, research facts, determine approach, and organize and coordinate information retrieval and documentation procedures. Exercise creativity, initiative, and an understanding of departmental objectives. May independently prepare communications, budgets, or data. Independently perform special projects that require a combined knowledge of administrative needs and technical operations. Select appropriate resources and analyzes data as required, i.e., budget projects, event planning, etc. Develop recommendations for executive approval and may assist with the implementation of contractual agreements or compliance activities. Respond to a wide variety of requests for information, policies and procedures, and executive action. Analyze needs and problems and determine approach and priority. Exercise tact, discretion, and an understanding of technical and organizational materials, issues, and impact. Take initiative to research technical or outside of policy questions. Evaluate and refer matters for appropriate handling, and coordinate, compile, and document relevant data and background information to support executive decision making or problem resolution. Work with highly sensitive, time sensitive, and confidential information. Provide back-up administrative support to other departments as necessary and other duties as required. Experience, Education and Specialized Knowledge and Skills Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Basic Qualifications AS degree. 5-7 years of prior administrative experience. Preferred Qualifications Strong computer skills, in particular Microsoft Outlook, Word, Excel, and PowerPoint. Prior executive assistant experience working in a busy, high-growth, and fast-paced environment. Administrative competence (typing, scheduling, e-mailing, coordinating calendars, and copying). Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes. Strong team player that has a customer service approach and is solution-oriented. Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Possesses strong written and verbal communication skills. Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways. Excitement about the vision and mission of Sage.
05/19/2023
Full time
General Scope and Summary SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for broad executive and departmental administrative support. We are actively seeking a dynamic, proactive Executive Assistant Consultant. In this position, you will be an integral contributor to Digital & Enterprise Capabilities (DEC), acting as the organizational and communication hub for the department and working collaboratively with other departments. This role is ideal for a self-starter that will be able to anticipate the needs of the department and will be successfully working autonomously. Roles and Responsibilities Coordinate internal and external calendar, meetings, schedule, travel arrangements, and expense reports and prepare necessary materials. Consult with leaders and team members as needed to solicit information, provide critical updates, and coordinate information and priorities. Exercise tact, diplomacy, and discretion in written and verbal communications. Plan, organize, and compile data. Analyze needs and problems, research facts, determine approach, and organize and coordinate information retrieval and documentation procedures. Exercise creativity, initiative, and an understanding of departmental objectives. May independently prepare communications, budgets, or data. Independently perform special projects that require a combined knowledge of administrative needs and technical operations. Select appropriate resources and analyzes data as required, i.e., budget projects, event planning, etc. Develop recommendations for executive approval and may assist with the implementation of contractual agreements or compliance activities. Respond to a wide variety of requests for information, policies and procedures, and executive action. Analyze needs and problems and determine approach and priority. Exercise tact, discretion, and an understanding of technical and organizational materials, issues, and impact. Take initiative to research technical or outside of policy questions. Evaluate and refer matters for appropriate handling, and coordinate, compile, and document relevant data and background information to support executive decision making or problem resolution. Work with highly sensitive, time sensitive, and confidential information. Provide back-up administrative support to other departments as necessary and other duties as required. Experience, Education and Specialized Knowledge and Skills Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Basic Qualifications AS degree. 5-7 years of prior administrative experience. Preferred Qualifications Strong computer skills, in particular Microsoft Outlook, Word, Excel, and PowerPoint. Prior executive assistant experience working in a busy, high-growth, and fast-paced environment. Administrative competence (typing, scheduling, e-mailing, coordinating calendars, and copying). Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes. Strong team player that has a customer service approach and is solution-oriented. Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Possesses strong written and verbal communication skills. Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways. Excitement about the vision and mission of Sage.
Description Wanted: Top notch, quality obsessed, team-oriented, and compassionate nurse leader! The Director of Nursing, officially referred to as Director of Professional Services (DPS). is responsible for the overall clinical operation of the Hospice agency. This role oversees the dynamic interdisciplinary team and works closely with the Administrator to ensure compliance and excellent patient care. Key responsibilities involve budgetary, management, leading the activities of the nursing team, providing clinical direction, and ensuring compliant growth and profitability of the agency. This individual drives team work, leads by example, and has a focus on quality care. We are the third largest hospice provider in the nation operating over 100 offices in 24 states. Heartland is a part of ProMedica Senior Care and one of the largest not-for-profit senior living organization for skilled nursing, assisted living and hospice care. Be a part of the team leading the nation in health care! 4756 - ProMedica Hospice Care - Des Moines - Serving Central Iowa Location 4756 - ProMedica Hospice Care - Des Moines - Serving Central Iowa Educational Requirements Currently licensed as a Registered Nurse (RN) in good standing with the State Board in which he/she practices.Bachelor of Science Degree in Nursing preferred. Position Requirements Minimum of one year experience in providing medical, oncology, home health care, or hospice nursing preferred. (This may be higher by state specific regulation.) Previous management or supervisory experience preferred.
05/19/2023
Full time
Description Wanted: Top notch, quality obsessed, team-oriented, and compassionate nurse leader! The Director of Nursing, officially referred to as Director of Professional Services (DPS). is responsible for the overall clinical operation of the Hospice agency. This role oversees the dynamic interdisciplinary team and works closely with the Administrator to ensure compliance and excellent patient care. Key responsibilities involve budgetary, management, leading the activities of the nursing team, providing clinical direction, and ensuring compliant growth and profitability of the agency. This individual drives team work, leads by example, and has a focus on quality care. We are the third largest hospice provider in the nation operating over 100 offices in 24 states. Heartland is a part of ProMedica Senior Care and one of the largest not-for-profit senior living organization for skilled nursing, assisted living and hospice care. Be a part of the team leading the nation in health care! 4756 - ProMedica Hospice Care - Des Moines - Serving Central Iowa Location 4756 - ProMedica Hospice Care - Des Moines - Serving Central Iowa Educational Requirements Currently licensed as a Registered Nurse (RN) in good standing with the State Board in which he/she practices.Bachelor of Science Degree in Nursing preferred. Position Requirements Minimum of one year experience in providing medical, oncology, home health care, or hospice nursing preferred. (This may be higher by state specific regulation.) Previous management or supervisory experience preferred.
Lesley seeks a Director of Counseling Services, who will serve to re-imagine and implement the next generation of counseling services aimed at meeting the psychological and developmental needs of the University student community. The selected individual, reporting to the Dean of Students, will be charged with developing a business plan to shape the delivery of innovative, high quality, student-centric counseling services, incorporating holistic practices which are central to Lesley's mission; possessing an interest, openness and experience with expressive therapies, mindfulness, and other alternative modalities; building a strategic plan to meet the objectives identified; providing overall operational, clinical, and inspirational leadership of the Counseling Center; providing direct short-term individual, group and teletherapy psychological counseling and crisis intervention services to a diverse and neurodiverse population of undergraduate and graduate students; providing referral services to outside resources when a higher level of care is needed; maintaining an active and current resource and referral network; providing consultation and support for students, faculty and staff during crisis situations; providing consultation and education to faculty and staff regarding student behavioral and emotional issues, classroom concerns and current behavioral health issues; directing the graduate internship training program; building effective, diverse, and connected teams; maintaining and promoting the highest ethical and professional standards; and working collaboratively with departments across campus to address coordinated student support. Requirements: The successful candidate will have at least five years' leadership experience in higher education with related experience operating a free-standing counseling center or other independent business; a minimum of eight years' experience as a licensed clinician; experience with best practice treatment protocols and innovative treatments in expressive therapies (art, music, dance, drama, etc.), meditation and mindfulness; experience serving BIPOC, LBGTQIA+ and neurodiverse communities; excellent communication (verbal, written and presentation) skills; business acumen including financial, leadership, planning, organization, problem-solving, and decision-making skills; interpersonal, and group facilitation skills; understanding of confidential and ethical matters within the professional of mental health and in a higher education setting; and have at least a Master's degree in Psychology, Counseling, or Social work. Ph.D. preferred. Must be currently licensed in Massachusetts. PM22
05/19/2023
Full time
Lesley seeks a Director of Counseling Services, who will serve to re-imagine and implement the next generation of counseling services aimed at meeting the psychological and developmental needs of the University student community. The selected individual, reporting to the Dean of Students, will be charged with developing a business plan to shape the delivery of innovative, high quality, student-centric counseling services, incorporating holistic practices which are central to Lesley's mission; possessing an interest, openness and experience with expressive therapies, mindfulness, and other alternative modalities; building a strategic plan to meet the objectives identified; providing overall operational, clinical, and inspirational leadership of the Counseling Center; providing direct short-term individual, group and teletherapy psychological counseling and crisis intervention services to a diverse and neurodiverse population of undergraduate and graduate students; providing referral services to outside resources when a higher level of care is needed; maintaining an active and current resource and referral network; providing consultation and support for students, faculty and staff during crisis situations; providing consultation and education to faculty and staff regarding student behavioral and emotional issues, classroom concerns and current behavioral health issues; directing the graduate internship training program; building effective, diverse, and connected teams; maintaining and promoting the highest ethical and professional standards; and working collaboratively with departments across campus to address coordinated student support. Requirements: The successful candidate will have at least five years' leadership experience in higher education with related experience operating a free-standing counseling center or other independent business; a minimum of eight years' experience as a licensed clinician; experience with best practice treatment protocols and innovative treatments in expressive therapies (art, music, dance, drama, etc.), meditation and mindfulness; experience serving BIPOC, LBGTQIA+ and neurodiverse communities; excellent communication (verbal, written and presentation) skills; business acumen including financial, leadership, planning, organization, problem-solving, and decision-making skills; interpersonal, and group facilitation skills; understanding of confidential and ethical matters within the professional of mental health and in a higher education setting; and have at least a Master's degree in Psychology, Counseling, or Social work. Ph.D. preferred. Must be currently licensed in Massachusetts. PM22
Senior Process Engineer European Recruitment are working closely with a fast growing battery tech company, based in Cambridge, who are looking for a talented Senior Process Engineer to join their team. In this role you will be a key member of a high performing team focused on developing the next generation high volume manufacturing processes that will connect the client's revolutionary product to the high growth energy storage market. You will focus on defining process needs for critical production steps and collaborate with internal and external machine design experts to identify, screen and develop process concepts that meet these specs. Responsibilities as Senior Process Engineer : Develop novel manufacturing processes that contribute to the establishment of our high volume production system, specifically for the electrode casting & converting process area. Characterize and develop deep understanding of critical material performance in the processes through experimentation and analysis. Leverage this insight in process development Perform equipment and process capability studies and make improvements based on those data driven results Design and run simple feasibility studies to find direction on novel processes Work closely with equipment design engineers and outside partners to successfully complete proof of concept Integrate process control parameters into manufacturing Requirements: At least 4-6 years of experience in a wide range of manufacturing processes Knowledge of coating technologies. Knowledge of various laminating technologies, including, heat sealing, adhesive sealing, etc. Experience with slitting, die cutting, roll-to-roll processes, intermittent motion processes, and vacuum lamination. Experience with in-line continuous vision system inspection systems. Demonstrated ability and passion to understand processes and the interaction between the material, equipment and the associated impact to product performance. Demonstrated ability to design, optimize and qualify processes with data driven decisions. Ability to create methods to generate data where none exist and to turn art into science by getting the numbers. Desirable experience: Lithium ion battery industry experience. Broad experience which also includes other processes such as mixing, extrusion, formation, etc. Experience with beta gage inspection systems. Experience in taking a process from lab scale, to pilot scale, and to high volume manufacturing. If this role is of any interest please apply directly on LinkedIn or send a copy of your CV to . By applying to this role you understand that we may collect your personal data and store and process it on our systems. For more information please see our Privacy Notice ()
05/19/2023
Full time
Senior Process Engineer European Recruitment are working closely with a fast growing battery tech company, based in Cambridge, who are looking for a talented Senior Process Engineer to join their team. In this role you will be a key member of a high performing team focused on developing the next generation high volume manufacturing processes that will connect the client's revolutionary product to the high growth energy storage market. You will focus on defining process needs for critical production steps and collaborate with internal and external machine design experts to identify, screen and develop process concepts that meet these specs. Responsibilities as Senior Process Engineer : Develop novel manufacturing processes that contribute to the establishment of our high volume production system, specifically for the electrode casting & converting process area. Characterize and develop deep understanding of critical material performance in the processes through experimentation and analysis. Leverage this insight in process development Perform equipment and process capability studies and make improvements based on those data driven results Design and run simple feasibility studies to find direction on novel processes Work closely with equipment design engineers and outside partners to successfully complete proof of concept Integrate process control parameters into manufacturing Requirements: At least 4-6 years of experience in a wide range of manufacturing processes Knowledge of coating technologies. Knowledge of various laminating technologies, including, heat sealing, adhesive sealing, etc. Experience with slitting, die cutting, roll-to-roll processes, intermittent motion processes, and vacuum lamination. Experience with in-line continuous vision system inspection systems. Demonstrated ability and passion to understand processes and the interaction between the material, equipment and the associated impact to product performance. Demonstrated ability to design, optimize and qualify processes with data driven decisions. Ability to create methods to generate data where none exist and to turn art into science by getting the numbers. Desirable experience: Lithium ion battery industry experience. Broad experience which also includes other processes such as mixing, extrusion, formation, etc. Experience with beta gage inspection systems. Experience in taking a process from lab scale, to pilot scale, and to high volume manufacturing. If this role is of any interest please apply directly on LinkedIn or send a copy of your CV to . By applying to this role you understand that we may collect your personal data and store and process it on our systems. For more information please see our Privacy Notice ()
Cambridge Health Alliance
Cambridge, Massachusetts
Location: CHA Cambridge Hospital Work Days: Mon-Fri 3p-8p Category: Clerical and Administrative Support Department: Psych CH 7 West Adult Nursing Job Type: PT20Plus HPW Work Shift: Evening Hours/Week: 25.00 Union: Yes Union Name: CH Laborers 380 7 West is an adult Psychiatric locked unit. There are 9 beds available on this inpatient unit of which we see various types of psychiatric illnesses such as Schizophrenia bi-polar and affective disorders, Personality disorders, Duel Diagnosis, Adjustment disorder, Psychosis, and use DBT/CBT Group Therapy. According to DMH we have a lower than average restraint rate, use a sensory approach to de-escalating patients, and all staff are educated in trauma-informed care which provides each patient with individualized care. Summary: Within the established hospital and departmental policies and procedures, perform various clerical and administrative support duties in Nursing Service Units. Essential job functions are focused on customer satisfaction, management of patient data, teamwork, and coordinating unit activities. Responsibilities: • Answers telephones in a timely and professional fashion • Schedules patient appointments • Greets and interacts with patients and visitors in a friendly and courteous manner. • Complies with HIPAA policies and procedures Management of Patient Data: • Accurately transcribes and processes orders per established procedures • Takes accurate messages and refers to appropriate person • Records vital signs in appropriate clinical sheets • Takes discharge charts apart, assembles new charts, and maintains chart with appropriate records and forms • Assembles and updates patient roster, daily worksheets and dietary charge sheets. Changes CSS cards every other day. Provides name identification on patient doors and medication drawers. • Prepares necessary requisitions for diagnostic tests and delivers requisitions to appropriate areas. • Processes charts for patients, checks for completeness (notes, signatures, etc.), reports incomplete charts to charge nurse. • Processes unit based charges per established procedure • Communicates with Admitting in a timely fashion to keep patient information as accurate as possible. Teamwork: • Assists in transporting of supplies, non-narcotics, and lab specimens as needed. • Follows abuse policy. • Communicates effectively with all members of the healthcare team. • Coordinates Unit Activities • Checks refrigerator temperature and eye wash station • Orders required stock and supplies. • Maintains work area in a clean and orderly condition. MINIMUM QUALIFICATIONS: Education/Training: High School/GED required Work Experience: One year hospital experience preferred. Working knowledge of word processing and use of e-mail preferred. In keeping with federal, state and local laws, Cambridge Health Alliance (CHA) policy forbids employees and associates to discriminate against anyone based on race, religion, color, gender, age, marital status, national origin, sexual orientation, gender identity, veteran status, disability or any other characteristic protected by law. We are committed to establishing and maintaining a workplace free of discrimination. We are fully committed to equal employment opportunity. We will not tolerate unlawful discrimination in the recruitment, hiring, termination, promotion, salary treatment or any other condition of employment or career development. Furthermore, we will not tolerate the use of discriminatory slurs, or other remarks, jokes or conduct, that in the judgment of CHA, encourage or permit an offensive or hostile work environment. Cambridge Health Alliance brings Care to the People - including your neighbors, friends and family. Our local hospitals and care centers serve our vibrant, diverse communities, and play an integral role in improving health. As passionate advocates for the underserved, we actively partner with our communities to take on challenging public health issues, and conduct important research to help reduce barriers to care. We believe that everyone deserves access to high quality, convenient health care. This is why our employees believe in where they work and why many build long, rewarding careers at CHA. Healthcare is changing rapidly. CHA has a strategic plan that charts a proactive course for our future. It is built on a vision of equity and excellence for everyone, every time. It also recognizes that our workforce is our most valuable asset and prioritizes competitive salaries, benefits and professional development opportunities for employees. The strategic plan is changing the way we provide care and improving the health and experience of our patients; we are looking for smart, committed, compassionate people who want to be part of making our vision of better health and equity a reality. At CHA, you can believe in where you work and go home every day knowing you made a difference. Join our team and help us bring Care to the People.
05/18/2023
Full time
Location: CHA Cambridge Hospital Work Days: Mon-Fri 3p-8p Category: Clerical and Administrative Support Department: Psych CH 7 West Adult Nursing Job Type: PT20Plus HPW Work Shift: Evening Hours/Week: 25.00 Union: Yes Union Name: CH Laborers 380 7 West is an adult Psychiatric locked unit. There are 9 beds available on this inpatient unit of which we see various types of psychiatric illnesses such as Schizophrenia bi-polar and affective disorders, Personality disorders, Duel Diagnosis, Adjustment disorder, Psychosis, and use DBT/CBT Group Therapy. According to DMH we have a lower than average restraint rate, use a sensory approach to de-escalating patients, and all staff are educated in trauma-informed care which provides each patient with individualized care. Summary: Within the established hospital and departmental policies and procedures, perform various clerical and administrative support duties in Nursing Service Units. Essential job functions are focused on customer satisfaction, management of patient data, teamwork, and coordinating unit activities. Responsibilities: • Answers telephones in a timely and professional fashion • Schedules patient appointments • Greets and interacts with patients and visitors in a friendly and courteous manner. • Complies with HIPAA policies and procedures Management of Patient Data: • Accurately transcribes and processes orders per established procedures • Takes accurate messages and refers to appropriate person • Records vital signs in appropriate clinical sheets • Takes discharge charts apart, assembles new charts, and maintains chart with appropriate records and forms • Assembles and updates patient roster, daily worksheets and dietary charge sheets. Changes CSS cards every other day. Provides name identification on patient doors and medication drawers. • Prepares necessary requisitions for diagnostic tests and delivers requisitions to appropriate areas. • Processes charts for patients, checks for completeness (notes, signatures, etc.), reports incomplete charts to charge nurse. • Processes unit based charges per established procedure • Communicates with Admitting in a timely fashion to keep patient information as accurate as possible. Teamwork: • Assists in transporting of supplies, non-narcotics, and lab specimens as needed. • Follows abuse policy. • Communicates effectively with all members of the healthcare team. • Coordinates Unit Activities • Checks refrigerator temperature and eye wash station • Orders required stock and supplies. • Maintains work area in a clean and orderly condition. MINIMUM QUALIFICATIONS: Education/Training: High School/GED required Work Experience: One year hospital experience preferred. Working knowledge of word processing and use of e-mail preferred. In keeping with federal, state and local laws, Cambridge Health Alliance (CHA) policy forbids employees and associates to discriminate against anyone based on race, religion, color, gender, age, marital status, national origin, sexual orientation, gender identity, veteran status, disability or any other characteristic protected by law. We are committed to establishing and maintaining a workplace free of discrimination. We are fully committed to equal employment opportunity. We will not tolerate unlawful discrimination in the recruitment, hiring, termination, promotion, salary treatment or any other condition of employment or career development. Furthermore, we will not tolerate the use of discriminatory slurs, or other remarks, jokes or conduct, that in the judgment of CHA, encourage or permit an offensive or hostile work environment. Cambridge Health Alliance brings Care to the People - including your neighbors, friends and family. Our local hospitals and care centers serve our vibrant, diverse communities, and play an integral role in improving health. As passionate advocates for the underserved, we actively partner with our communities to take on challenging public health issues, and conduct important research to help reduce barriers to care. We believe that everyone deserves access to high quality, convenient health care. This is why our employees believe in where they work and why many build long, rewarding careers at CHA. Healthcare is changing rapidly. CHA has a strategic plan that charts a proactive course for our future. It is built on a vision of equity and excellence for everyone, every time. It also recognizes that our workforce is our most valuable asset and prioritizes competitive salaries, benefits and professional development opportunities for employees. The strategic plan is changing the way we provide care and improving the health and experience of our patients; we are looking for smart, committed, compassionate people who want to be part of making our vision of better health and equity a reality. At CHA, you can believe in where you work and go home every day knowing you made a difference. Join our team and help us bring Care to the People.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. Lilly is passionate about the discovery, development and commercialization of potential new medicines that will impact and improve the lives of patients. Our Lilly Genetic Medicine (LGM) team is an innovation-focused group working to identify, develop and apply cutting-edge technologies to deliver maximum benefit to our patients. Our agile and diverse team strives to operate as an autonomous 'biotech-like' company within the walls of Lilly. We are looking for a highly motivated and experienced candidate for the role to lead our hepatic DNA editing delivery; process, analytics, and scale-up of non-viral nanomedicines ( e.g. , LNPs, PNPs) efforts. The candidate will have experience in hepatic non-viral delivery and scale-up, process development, tech transfer to CMC, etc. of non-viral nanoparticles. In addition, the candidate will have functional knowledge of in vitro biology, in vivo biology, DNA editing, and demonstrated experience managing cross-collaborative projects. Do you have an aptitude for innovative approaches focused on identifying impactful therapies for the patient? We want you on our team! Key responsibilities Manage the scientific functions and lead the activities of a research group, and may be required to coordinate multiple teams to achieve project goals The role's responsibilities include the maintenance of organizational balance across teams, as well as setting the scientific directions for personnel Optimize iinterdisciplinary understanding and synergy within the team and integrates activities with those of other Departments and Project Teams, to help shape cohesive Research plans Manages activities of the research group across project boundaries Mentors on scientific and ethical development, motivates personnel and resolves conflicts Ensures personnel goal setting is effectively linked to corporate and department goals Manages the activities of staff and provides them insightful guidance to succeed and grow Oversees activities of staff and adapts personnel deployment to changing priorities, to ensure key goals of all projects are met on time Helps define scientific and strategic directions and develops champions of technological innovation for the research group Directs effective, timely and ethical publication and patenting activities for the group Leads effective management of CRO contracts and/or external scientific collaborations Maintains the excellence of standards for structure and interpretation of all laboratory records, electronic database entries, internal reports, patents and external communications from the group Communicates company objectives to the group and availability of group resources and methods to Project Team(s), in a clear and timely manner, and develops abilities of others in this role Leads preparation of lucid scientific reports for all other branches and levels of the organization and its collaborators, presents expertly when called upon to various stakeholders and senior leadership Responsible for developing and cultivating and high achieving organization Basic Qualifications: M.S. and 15+ years of experience or PhD and 7-10+ years of experience in Pharmaceutical Sciences, Process Sciences, Chemistry, Chemical Engineering, or other relevant scientific discipline. Additional Skills/Preferences: Advanced expertise in state-of-the-art non-viral (e.g., LNP, PNP) delivery technologies for therapeutic applications with a focus on the discovery, development, and implementation of strategies for tissue-specific delivery Demonstrated scientific productivity as evidenced by a strong publication record in top tier journals or equivalent industry accomplishment Highly developed scientific leadership qualities and established prowess integrating the activities of distinct functional groups across multiple projects Greater aptitude for identifying productive new research initiatives/directions Experienced mentor who effectively infuses confidence and team commitment Exhibits a record of excellent operational and ethical standards, and team-improvement Scientifically diverse and effective communicator Possesses greater knowledge of the drug development process and a keener awareness of issues therein Demonstrated success in resolving important organizational problems and/or infusing innovation Strong track record of developing non-viral delivery technologies for therapeutic applications Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
05/16/2023
Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges. Lilly is passionate about the discovery, development and commercialization of potential new medicines that will impact and improve the lives of patients. Our Lilly Genetic Medicine (LGM) team is an innovation-focused group working to identify, develop and apply cutting-edge technologies to deliver maximum benefit to our patients. Our agile and diverse team strives to operate as an autonomous 'biotech-like' company within the walls of Lilly. We are looking for a highly motivated and experienced candidate for the role to lead our hepatic DNA editing delivery; process, analytics, and scale-up of non-viral nanomedicines ( e.g. , LNPs, PNPs) efforts. The candidate will have experience in hepatic non-viral delivery and scale-up, process development, tech transfer to CMC, etc. of non-viral nanoparticles. In addition, the candidate will have functional knowledge of in vitro biology, in vivo biology, DNA editing, and demonstrated experience managing cross-collaborative projects. Do you have an aptitude for innovative approaches focused on identifying impactful therapies for the patient? We want you on our team! Key responsibilities Manage the scientific functions and lead the activities of a research group, and may be required to coordinate multiple teams to achieve project goals The role's responsibilities include the maintenance of organizational balance across teams, as well as setting the scientific directions for personnel Optimize iinterdisciplinary understanding and synergy within the team and integrates activities with those of other Departments and Project Teams, to help shape cohesive Research plans Manages activities of the research group across project boundaries Mentors on scientific and ethical development, motivates personnel and resolves conflicts Ensures personnel goal setting is effectively linked to corporate and department goals Manages the activities of staff and provides them insightful guidance to succeed and grow Oversees activities of staff and adapts personnel deployment to changing priorities, to ensure key goals of all projects are met on time Helps define scientific and strategic directions and develops champions of technological innovation for the research group Directs effective, timely and ethical publication and patenting activities for the group Leads effective management of CRO contracts and/or external scientific collaborations Maintains the excellence of standards for structure and interpretation of all laboratory records, electronic database entries, internal reports, patents and external communications from the group Communicates company objectives to the group and availability of group resources and methods to Project Team(s), in a clear and timely manner, and develops abilities of others in this role Leads preparation of lucid scientific reports for all other branches and levels of the organization and its collaborators, presents expertly when called upon to various stakeholders and senior leadership Responsible for developing and cultivating and high achieving organization Basic Qualifications: M.S. and 15+ years of experience or PhD and 7-10+ years of experience in Pharmaceutical Sciences, Process Sciences, Chemistry, Chemical Engineering, or other relevant scientific discipline. Additional Skills/Preferences: Advanced expertise in state-of-the-art non-viral (e.g., LNP, PNP) delivery technologies for therapeutic applications with a focus on the discovery, development, and implementation of strategies for tissue-specific delivery Demonstrated scientific productivity as evidenced by a strong publication record in top tier journals or equivalent industry accomplishment Highly developed scientific leadership qualities and established prowess integrating the activities of distinct functional groups across multiple projects Greater aptitude for identifying productive new research initiatives/directions Experienced mentor who effectively infuses confidence and team commitment Exhibits a record of excellent operational and ethical standards, and team-improvement Scientifically diverse and effective communicator Possesses greater knowledge of the drug development process and a keener awareness of issues therein Demonstrated success in resolving important organizational problems and/or infusing innovation Strong track record of developing non-viral delivery technologies for therapeutic applications Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Who is BlueRock? BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives. The Manufacturing GMP Support Sr Specialist provides investigation and other quality system continuous improvement to the GMP teams at BlueRock by performing complex root cause analysis, working with stakeholders to identify corrective and preventative actions, ensure the Manufacturing team is audit ready, facilitate reviews, and investigate product complaints and adverse events (within CMC). The Mfg GMP Support Sr Spec will report to the Director, GMP Support. Responsibilities:This position performs related tasks associated with the deviation and change management processes (deviations, investigations, change controls, corrective and preventative actions, and document workflows) to ensure the written investigation report contains the technical merit and completeness according to phase appropriate regulatory expectations.This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory deviations. This position will lead root cause analysis sessions with site SME's and determine the associated corrective action to prevent the deviation from recurring. This person will be a key player in the GMP team and a champion for quality priority principles and compliance within the Manufacturing organization.Independently prepares quality system and regulatory documentation required to implement corrective actions and changes to various GMP processes, SOPs and other documents and in accordance with phase appropriate cGMP standards and written procedures.Follow up to determine if corrective actions adequately addressed root cause of NC event.Independently monitoring and proactively progressing multiple projects concurrently; identifying, addressing, and/or raising potential obstacles in a timely manner.Collaborates with other leaders across the organization and assists in the continuous improvement and life cycle management of implemented GMP policies and quality management systems with phase appropriate risk-based approach.Develops a comprehensive understanding of the manufacturing processes.Provides consistent direction and ensures timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone through close collaboration with Manufacturing and Quality teams. Use Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste.Foster a culture of continuous improvement through employee training and mentoring while focusing on operational efficiency and the elimination of "non-value added" activities.Following lean manufacturing practices, track deviations, events and provide reports or presentations to management on investigation findings, trending and status as requested. Recognize and act on potential compliance issues and opportunities for process changes/improvement. Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA). Ensuring safe and compliant cGMP operations and maintains permanent inspection readiness; Actively supports regulatory inspections.Staying current with industry trends and standards and participating in best practice forums consistent with function responsibilities. Coaching and mentoring of colleagues on Investigation Program fundamentals and best practices, human performance HP improvement.30-40% travel to multiple sites (Cambridge and Toronto)Requirements:Bachelor's Degree in Sciences, Engineering, Pharmaceutical Technology or equivalent scientific degree Eight years total experience with a minimum of 3+ years of experience in a cGMP regulated clinical or commercial manufacturing cell therapy/biotech environment, preferred and additional 3+ years of technical writing experience, with deviations, CAPAs and other technical reports in the cell+gene therapy/biotech industry.Excel in a risk-based, phase appropriate quality focused organization. Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills. Have an attention to detail. Have strong technical writing and interpersonal communication skills. Can learn and apply computerized systems for the performance of daily tasks. Have experience navigating a controlled quality system. Significant experience with deviation or investigation management processes, reports and systems. Ability to author and review standard operating procedures, on-the-job-trainings, and other controlled documents.Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report.Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment using: 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, Human Error Reduction. Competencies • Action Oriented • Collaborates • Communicates Effectively • Decision Quality • Drives Results • Balances Stakeholders • Instills Trust • Organizational SavvyProficient in cGMP's and multi-national biopharmaceutical/cell therapy regulationsExcellent verbal/written communication skills and ability to influence at all levels Ability to think strategically, and to translate strategy into action Ability to prioritize and provide clear direction to team members in a highly dynamic environment BlueRock Therapeutics Company Culture HighlightsWinner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably. Check us out on Comparably: Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
05/16/2023
Full time
Who is BlueRock? BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology. What Are We Doing? Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit. We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options. We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients' lives. The Manufacturing GMP Support Sr Specialist provides investigation and other quality system continuous improvement to the GMP teams at BlueRock by performing complex root cause analysis, working with stakeholders to identify corrective and preventative actions, ensure the Manufacturing team is audit ready, facilitate reviews, and investigate product complaints and adverse events (within CMC). The Mfg GMP Support Sr Spec will report to the Director, GMP Support. Responsibilities:This position performs related tasks associated with the deviation and change management processes (deviations, investigations, change controls, corrective and preventative actions, and document workflows) to ensure the written investigation report contains the technical merit and completeness according to phase appropriate regulatory expectations.This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory deviations. This position will lead root cause analysis sessions with site SME's and determine the associated corrective action to prevent the deviation from recurring. This person will be a key player in the GMP team and a champion for quality priority principles and compliance within the Manufacturing organization.Independently prepares quality system and regulatory documentation required to implement corrective actions and changes to various GMP processes, SOPs and other documents and in accordance with phase appropriate cGMP standards and written procedures.Follow up to determine if corrective actions adequately addressed root cause of NC event.Independently monitoring and proactively progressing multiple projects concurrently; identifying, addressing, and/or raising potential obstacles in a timely manner.Collaborates with other leaders across the organization and assists in the continuous improvement and life cycle management of implemented GMP policies and quality management systems with phase appropriate risk-based approach.Develops a comprehensive understanding of the manufacturing processes.Provides consistent direction and ensures timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone through close collaboration with Manufacturing and Quality teams. Use Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste.Foster a culture of continuous improvement through employee training and mentoring while focusing on operational efficiency and the elimination of "non-value added" activities.Following lean manufacturing practices, track deviations, events and provide reports or presentations to management on investigation findings, trending and status as requested. Recognize and act on potential compliance issues and opportunities for process changes/improvement. Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA). Ensuring safe and compliant cGMP operations and maintains permanent inspection readiness; Actively supports regulatory inspections.Staying current with industry trends and standards and participating in best practice forums consistent with function responsibilities. Coaching and mentoring of colleagues on Investigation Program fundamentals and best practices, human performance HP improvement.30-40% travel to multiple sites (Cambridge and Toronto)Requirements:Bachelor's Degree in Sciences, Engineering, Pharmaceutical Technology or equivalent scientific degree Eight years total experience with a minimum of 3+ years of experience in a cGMP regulated clinical or commercial manufacturing cell therapy/biotech environment, preferred and additional 3+ years of technical writing experience, with deviations, CAPAs and other technical reports in the cell+gene therapy/biotech industry.Excel in a risk-based, phase appropriate quality focused organization. Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills. Have an attention to detail. Have strong technical writing and interpersonal communication skills. Can learn and apply computerized systems for the performance of daily tasks. Have experience navigating a controlled quality system. Significant experience with deviation or investigation management processes, reports and systems. Ability to author and review standard operating procedures, on-the-job-trainings, and other controlled documents.Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report.Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment using: 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, Human Error Reduction. Competencies • Action Oriented • Collaborates • Communicates Effectively • Decision Quality • Drives Results • Balances Stakeholders • Instills Trust • Organizational SavvyProficient in cGMP's and multi-national biopharmaceutical/cell therapy regulationsExcellent verbal/written communication skills and ability to influence at all levels Ability to think strategically, and to translate strategy into action Ability to prioritize and provide clear direction to team members in a highly dynamic environment BlueRock Therapeutics Company Culture HighlightsWinner of Comparably's Award for Best Company for Diversity 2022Winner of Comparably's Award for Best Company for Women 2022Winner of Comparably's Award for Best CEO 2022BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably. Check us out on Comparably: Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
Job Description & Requirements Certified Registered Nurse Anesthetist (CRNA) - StartDate: ASAP Available Shifts: Call This facility is seeking a Certified Registered Nurse Anesthetist (CRNA) for locum tenens support as they look to fill a current need. Details & requirements for this opportunity: Schedule: In-house weekend beeper call Job Setting: 5000 cases per year Types of Cases: No hearts, no trauma Credentialing Timeframe: 90 days Electronic Medical Record (EMR): EPIC Board Certified Facility Location Opposite the Charles River from Boston, Cambridge is just a hop away from Massachusetts' most exciting metropolitan area. Cambridge is the home of two of America's most prestigious and famous universities, Harvard and MIT. While residents find themselves in prime position to take advantage of all the cultural and entertainment options in Boston, Cambridge proper offers a wealth of leisure activities, sights and sounds. Culture seekers and history buffs will be delighted by Harvard Art Museum and the Harvard Museum of Natural History, not to mention the many historic buildings that adorn the city's storied streets. Fans of the performing arts can take in a show at one of several theaters in the area, including the Brattle Theatre and The Lily Pad. Outdoors types can visit the city's parks for canoeing, hiking and cycling. Job Benefits AMN Healthcare typically arranges medical or dental malpractice insurance for the contractor providers we match to client opportunities. In addition, our locum tenens can receive highly competitive pay and a dedicated team that handles all travel, lodging, rentals and transportation needs. Additionally, our Physician Mobility initiative decreases the amount of time you must wait to work at a facility where you are presented or have worked from 24 months to 6 months. About the Company Staff Care, an AMN Healthcare company, is the nation's leader in locum tenens staffing. We provide flexible, temporary employment options for physicians, clinicians, and other allied health professionals in all specialties with a variety of healthcare organizations, typically with interim contracts lasting from one week to one year. AMN Healthcare is an EEO/AA/Disability/Protected Veteran Employer. We encourage minority and female applicants to apply. Nurse Anesthetist, Certified Registered, Healthcare, Health Care, Patient Care, Hospital, CRNA
05/16/2023
Full time
Job Description & Requirements Certified Registered Nurse Anesthetist (CRNA) - StartDate: ASAP Available Shifts: Call This facility is seeking a Certified Registered Nurse Anesthetist (CRNA) for locum tenens support as they look to fill a current need. Details & requirements for this opportunity: Schedule: In-house weekend beeper call Job Setting: 5000 cases per year Types of Cases: No hearts, no trauma Credentialing Timeframe: 90 days Electronic Medical Record (EMR): EPIC Board Certified Facility Location Opposite the Charles River from Boston, Cambridge is just a hop away from Massachusetts' most exciting metropolitan area. Cambridge is the home of two of America's most prestigious and famous universities, Harvard and MIT. While residents find themselves in prime position to take advantage of all the cultural and entertainment options in Boston, Cambridge proper offers a wealth of leisure activities, sights and sounds. Culture seekers and history buffs will be delighted by Harvard Art Museum and the Harvard Museum of Natural History, not to mention the many historic buildings that adorn the city's storied streets. Fans of the performing arts can take in a show at one of several theaters in the area, including the Brattle Theatre and The Lily Pad. Outdoors types can visit the city's parks for canoeing, hiking and cycling. Job Benefits AMN Healthcare typically arranges medical or dental malpractice insurance for the contractor providers we match to client opportunities. In addition, our locum tenens can receive highly competitive pay and a dedicated team that handles all travel, lodging, rentals and transportation needs. Additionally, our Physician Mobility initiative decreases the amount of time you must wait to work at a facility where you are presented or have worked from 24 months to 6 months. About the Company Staff Care, an AMN Healthcare company, is the nation's leader in locum tenens staffing. We provide flexible, temporary employment options for physicians, clinicians, and other allied health professionals in all specialties with a variety of healthcare organizations, typically with interim contracts lasting from one week to one year. AMN Healthcare is an EEO/AA/Disability/Protected Veteran Employer. We encourage minority and female applicants to apply. Nurse Anesthetist, Certified Registered, Healthcare, Health Care, Patient Care, Hospital, CRNA
Description and Requirements As one of Premium's vital merchandising lead and trainers, you'll ensure success of Premium's field team by connecting merchandisers to our culture and providing the necessary resources to achieve client objectives in retail stores. Your efforts training merchandisers and executing merchandising activities in your area will ensure merchandising excellence for Premium clients. What's in it for you? Flexibility in scheduling your work hours. Ability to influence field team success through training. Opportunity to take the lead on projects and directly impact client success. A clear-cut path for advancing your career within Premium. Quarterly bonus opportunity. Health plan options including no-copay telemedicine, regardless of hours worked. What will you do? Ensure execution of key merchandising objectives for Premium clients by effectively training, mentoring and providing feedback to merchandisers in your assigned market. Assist merchandising team members in your market in order to work through challenges and obstacles. Provide project leadership and merchandising coverage across retail stores to ensure we get the job done for clients. Complete specialized training and certifications. Partner directly with store management and associates to ensure they understand and are aware of the activities merchandisers are performing in their location. Lead by example when reporting work to demonstrate success and provide visibility of our efforts to the Premium clients. How will you succeed? Sharing your expertise and being passionate about training other and ensuring merchandisers understand how to succeed. Looking for creative ways to solve problems. Dedicating yourself to continually improving your stores and the success of other merchandisers. Using your awesome communication skills and staying organized. Building strong relationships with field team members, Premium management and retail partners within your assigned area(s). So, are you Premium's next Merchandising Lead and Trainer? For more information about our merchandising team, visit Equal Opportunity Employer (Disabled, Veteran) Under applicable requirements, such as the San Francisco FCO and the Los Angeles FCHIO, we consider for employment qualified applicants with arrest and conviction records or criminal histories E-Verify Employer
05/16/2023
Full time
Description and Requirements As one of Premium's vital merchandising lead and trainers, you'll ensure success of Premium's field team by connecting merchandisers to our culture and providing the necessary resources to achieve client objectives in retail stores. Your efforts training merchandisers and executing merchandising activities in your area will ensure merchandising excellence for Premium clients. What's in it for you? Flexibility in scheduling your work hours. Ability to influence field team success through training. Opportunity to take the lead on projects and directly impact client success. A clear-cut path for advancing your career within Premium. Quarterly bonus opportunity. Health plan options including no-copay telemedicine, regardless of hours worked. What will you do? Ensure execution of key merchandising objectives for Premium clients by effectively training, mentoring and providing feedback to merchandisers in your assigned market. Assist merchandising team members in your market in order to work through challenges and obstacles. Provide project leadership and merchandising coverage across retail stores to ensure we get the job done for clients. Complete specialized training and certifications. Partner directly with store management and associates to ensure they understand and are aware of the activities merchandisers are performing in their location. Lead by example when reporting work to demonstrate success and provide visibility of our efforts to the Premium clients. How will you succeed? Sharing your expertise and being passionate about training other and ensuring merchandisers understand how to succeed. Looking for creative ways to solve problems. Dedicating yourself to continually improving your stores and the success of other merchandisers. Using your awesome communication skills and staying organized. Building strong relationships with field team members, Premium management and retail partners within your assigned area(s). So, are you Premium's next Merchandising Lead and Trainer? For more information about our merchandising team, visit Equal Opportunity Employer (Disabled, Veteran) Under applicable requirements, such as the San Francisco FCO and the Los Angeles FCHIO, we consider for employment qualified applicants with arrest and conviction records or criminal histories E-Verify Employer
Director Tissue-Enhanced Delivery Technologies at Biogen, Cambridge, MA Created: 06 October 2021 About This Role The mission of Biogen's Biologics Drug Discovery group is to design, optimize, and develop high-quality differentiated protein therapeutics that become transformative medicines. This group is a part of the BTMS (Biotherapeutics and Medicinal Sciences) organization, Biogen's modality unit. Using new technologies, cutting-edge science, and strong internal and external partnerships, we are leveraging our expertise in antibody discovery, protein and cell engineering, and biochemistry to transform the field of neuroscience. Biogen is looking for an innovative and dedicated scientist to become the Director/Head of the Tissue-Enhanced Delivery Technologies group, who will lead direct reports as well as a cross-functional effort to identify and validate novel methods for enhancing delivery of biologics, oligonucleotides (including ASOs), and gene therapy modalities to tissues including muscle and brain. More information is available in the full advertisement here .
05/16/2023
Full time
Director Tissue-Enhanced Delivery Technologies at Biogen, Cambridge, MA Created: 06 October 2021 About This Role The mission of Biogen's Biologics Drug Discovery group is to design, optimize, and develop high-quality differentiated protein therapeutics that become transformative medicines. This group is a part of the BTMS (Biotherapeutics and Medicinal Sciences) organization, Biogen's modality unit. Using new technologies, cutting-edge science, and strong internal and external partnerships, we are leveraging our expertise in antibody discovery, protein and cell engineering, and biochemistry to transform the field of neuroscience. Biogen is looking for an innovative and dedicated scientist to become the Director/Head of the Tissue-Enhanced Delivery Technologies group, who will lead direct reports as well as a cross-functional effort to identify and validate novel methods for enhancing delivery of biologics, oligonucleotides (including ASOs), and gene therapy modalities to tissues including muscle and brain. More information is available in the full advertisement here .
Lahey Hospital & Medical Center
Cambridge, Massachusetts
Mount Auburn Hospital is currently recruiting a full time Chief for our rapidly growing Urology Division. The incoming Chief will have both clinical and administrative responsibilities and will oversee a multidisciplinary team of committed and talented staff. The Chief will develop a strategic plan for continued growth, oversee and develop outstanding professional staff and identify quality improvement initiatives. This is an exciting opportunity for personal growth and we are confident this role will provide an exceptional opportunity to further develop as a Clinician educator within our organization. Academic appointment at Harvard Medical School available commensurate with medical school criteria. Fully integrated EMR (Epic) utilized throughout our ambulatory and inpatient sites. Tertiary hospital affiliation with Beth Israel Deaconess Medical Center. A Urology Division that is equipped with updated technologies Organizational commitment and focus on patient safety and quality outcomes. Collegial colleagues similarly committed to provide care to a diverse and growing patient population. Exceptional compensation and benefits package. Ideal candidate will have: 3+ years of progressive leadership experience. 5+ years of clinical experience. History of successful program development is preferred. Strong commitment to quality, demonstrated ability to build effective teams and interest in process improvement. Excellent communication and clinical skills. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law. We strongly encourage both women and minorities to apply
05/16/2023
Full time
Mount Auburn Hospital is currently recruiting a full time Chief for our rapidly growing Urology Division. The incoming Chief will have both clinical and administrative responsibilities and will oversee a multidisciplinary team of committed and talented staff. The Chief will develop a strategic plan for continued growth, oversee and develop outstanding professional staff and identify quality improvement initiatives. This is an exciting opportunity for personal growth and we are confident this role will provide an exceptional opportunity to further develop as a Clinician educator within our organization. Academic appointment at Harvard Medical School available commensurate with medical school criteria. Fully integrated EMR (Epic) utilized throughout our ambulatory and inpatient sites. Tertiary hospital affiliation with Beth Israel Deaconess Medical Center. A Urology Division that is equipped with updated technologies Organizational commitment and focus on patient safety and quality outcomes. Collegial colleagues similarly committed to provide care to a diverse and growing patient population. Exceptional compensation and benefits package. Ideal candidate will have: 3+ years of progressive leadership experience. 5+ years of clinical experience. History of successful program development is preferred. Strong commitment to quality, demonstrated ability to build effective teams and interest in process improvement. Excellent communication and clinical skills. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law. We strongly encourage both women and minorities to apply
Job description: This is a HYBRID role We are seeking a talented senior engineer to join the digital design. The successful candidate will contribute to FPGA development with an emphasis on validation and test/support. Candidate must have experience using high level design, simulation and verification tools and be familiar with process flows supporting design and verification for digital FPGA efforts. Preference will be given to candidates with an understanding of sensor control, filter design and algorithm implementation in hardware. Direct experience with embedded FPGA design is required. Required Qualifications: BSEE with 6 years relevant experience Fluent in SystemVerilog/VHDL Experience with Xiliinx Vivado design tools Implementation of fixed-point arithmetic, filter design, algorithm design and other DSP functions Ability to debug designs simulated in a UVM environment Experience with git and other version control systems Experience with design closure including timing, power and area for SWaP constrained designs Strong lab-debugging experience, including use of Xilinx integrated logic analyzers (ILAs) and experience with common test equipment such as oscilloscopes, digital multi-meters and logic analyzers. Strong analysis and problem solving skills Required to be on-site at least 4 days/week initially Preferred Qualifications: MSEE with 6 years relevant experience Experience with Linux and scripting languages Experience integrating FPGAs with sensors in-the-loop Experience with control theory and/or design and implementation of control loops Experience with bug tracking and continuous integration / continuous development (CI/CD) UVM skills (Test and/or Test Bench development) Experience with Matlab/Simulink Experience working with PCB designers Active US secret/TS clearance strongly preferred Security Requirement: Applicants selected for this position will be required to obtain and maintain a government security clearance. Current in scope Secret or Top Secret strongly preferred. Qualifications: Required Qualifications: BSEE with 6 years relevant experience Fluent in SystemVerilog/VHDL Experience with Xiliinx Vivado design tools Implementation of fixed-point arithmetic, filter design, algorithm design and other DSP functions Ability to debug designs simulated in a UVM environment Experience with git and other version control systems Experience with design closure including timing, power and area for SWaP constrained designs Strong lab-debugging experience, including use of Xilinx integrated logic analyzers (ILAs) and experience with common test equipment such as oscilloscopes, digital multi-meters and logic analyzers. Strong analysis and problem solving skills Required to be on-site at least 4 days/week initially Preferred Qualifications: MSEE with 6 years relevant experience Experience with Linux and scripting languages Experience integrating FPGAs with sensors in-the-loop Experience with control theory and/or design and implementation of control loops Experience with bug tracking and continuous integration / continuous development (CI/CD) UVM skills (Test and/or Test Bench development) Experience with Matlab/Simulink Experience working with PCB designers Active US secret/TS clearance strongly preferred Security Requirement: Applicants selected for this position will be required to obtain and maintain a government security clearance. Current in scope Secret or Top Secret strongly preferred. Why is This a Great Opportunity: We are seeking a talented senior engineer to join the digital design. The successful candidate will contribute to FPGA development with an emphasis on validation and test/support. Salary Type : Annual Salary Salary Min : 150000 Salary Max : 165000 Currency Type : US Dollars
05/16/2023
Full time
Job description: This is a HYBRID role We are seeking a talented senior engineer to join the digital design. The successful candidate will contribute to FPGA development with an emphasis on validation and test/support. Candidate must have experience using high level design, simulation and verification tools and be familiar with process flows supporting design and verification for digital FPGA efforts. Preference will be given to candidates with an understanding of sensor control, filter design and algorithm implementation in hardware. Direct experience with embedded FPGA design is required. Required Qualifications: BSEE with 6 years relevant experience Fluent in SystemVerilog/VHDL Experience with Xiliinx Vivado design tools Implementation of fixed-point arithmetic, filter design, algorithm design and other DSP functions Ability to debug designs simulated in a UVM environment Experience with git and other version control systems Experience with design closure including timing, power and area for SWaP constrained designs Strong lab-debugging experience, including use of Xilinx integrated logic analyzers (ILAs) and experience with common test equipment such as oscilloscopes, digital multi-meters and logic analyzers. Strong analysis and problem solving skills Required to be on-site at least 4 days/week initially Preferred Qualifications: MSEE with 6 years relevant experience Experience with Linux and scripting languages Experience integrating FPGAs with sensors in-the-loop Experience with control theory and/or design and implementation of control loops Experience with bug tracking and continuous integration / continuous development (CI/CD) UVM skills (Test and/or Test Bench development) Experience with Matlab/Simulink Experience working with PCB designers Active US secret/TS clearance strongly preferred Security Requirement: Applicants selected for this position will be required to obtain and maintain a government security clearance. Current in scope Secret or Top Secret strongly preferred. Qualifications: Required Qualifications: BSEE with 6 years relevant experience Fluent in SystemVerilog/VHDL Experience with Xiliinx Vivado design tools Implementation of fixed-point arithmetic, filter design, algorithm design and other DSP functions Ability to debug designs simulated in a UVM environment Experience with git and other version control systems Experience with design closure including timing, power and area for SWaP constrained designs Strong lab-debugging experience, including use of Xilinx integrated logic analyzers (ILAs) and experience with common test equipment such as oscilloscopes, digital multi-meters and logic analyzers. Strong analysis and problem solving skills Required to be on-site at least 4 days/week initially Preferred Qualifications: MSEE with 6 years relevant experience Experience with Linux and scripting languages Experience integrating FPGAs with sensors in-the-loop Experience with control theory and/or design and implementation of control loops Experience with bug tracking and continuous integration / continuous development (CI/CD) UVM skills (Test and/or Test Bench development) Experience with Matlab/Simulink Experience working with PCB designers Active US secret/TS clearance strongly preferred Security Requirement: Applicants selected for this position will be required to obtain and maintain a government security clearance. Current in scope Secret or Top Secret strongly preferred. Why is This a Great Opportunity: We are seeking a talented senior engineer to join the digital design. The successful candidate will contribute to FPGA development with an emphasis on validation and test/support. Salary Type : Annual Salary Salary Min : 150000 Salary Max : 165000 Currency Type : US Dollars
Ipsen Biopharmaceuticals, Inc.
Cambridge, Massachusetts
Title: QA Manager Company: Ipsen Bioscience, Inc. Job Description: Summary The QA Manager oversees Operational Quality Systems while working with Global Quality to implement and maintain these systems. You will provide quality leadership and support for manufacturing and testing at the facility while also providing technical quality expertise and guidance to internal cross-functional teams. Job Responsibilities Ensure that an effective QA service is established and maintained for all operations at the site/entity so that product quality and customer needs are met in an efficient manner. Quality review and approval on GMP documentation and records. Regulatory filing support. Establish and maintain systems that ensure the highest standards of Quality Assurance across the site/entity are met. Ensure that all critical deviations and complaints are investigated with timely CAPA (Corrective Action Preventative Action) and reviews effectiveness of CAPA. Provide effective GxP training for relevant personnel involved in GxP activities on site where applicable. Manage metric process with the team and prepare data for Quality management reviews. Manage Annual Product Quality Review process. Accountable for vendor management and process shared with Signes. Quality disposition of materials and drug product. Drive continuous improvement initiatives within function. Constantly scan the market for best practices and innovative changes to mitigate risk or stay ahead of the curve. Knowledge, Abilities and Experience Bachelor's / Master's degree in science related discipline. Minimum of 8 years of experience within the GMP quality function of the pharmaceutical/biotech industry. Significant experience in Quality role with FDA / IMB regulated company. Experienced in leading QA activities and participating multiple regulatory inspections. Demonstrated ability to work in a team environment as well as manage projects independently. Must have a thorough understanding of FDA and ICH quality regulations. Experience in Quality Systems Management is required. Excellent written and oral communication with exceptional organization and multitasking ability. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
05/15/2023
Full time
Title: QA Manager Company: Ipsen Bioscience, Inc. Job Description: Summary The QA Manager oversees Operational Quality Systems while working with Global Quality to implement and maintain these systems. You will provide quality leadership and support for manufacturing and testing at the facility while also providing technical quality expertise and guidance to internal cross-functional teams. Job Responsibilities Ensure that an effective QA service is established and maintained for all operations at the site/entity so that product quality and customer needs are met in an efficient manner. Quality review and approval on GMP documentation and records. Regulatory filing support. Establish and maintain systems that ensure the highest standards of Quality Assurance across the site/entity are met. Ensure that all critical deviations and complaints are investigated with timely CAPA (Corrective Action Preventative Action) and reviews effectiveness of CAPA. Provide effective GxP training for relevant personnel involved in GxP activities on site where applicable. Manage metric process with the team and prepare data for Quality management reviews. Manage Annual Product Quality Review process. Accountable for vendor management and process shared with Signes. Quality disposition of materials and drug product. Drive continuous improvement initiatives within function. Constantly scan the market for best practices and innovative changes to mitigate risk or stay ahead of the curve. Knowledge, Abilities and Experience Bachelor's / Master's degree in science related discipline. Minimum of 8 years of experience within the GMP quality function of the pharmaceutical/biotech industry. Significant experience in Quality role with FDA / IMB regulated company. Experienced in leading QA activities and participating multiple regulatory inspections. Demonstrated ability to work in a team environment as well as manage projects independently. Must have a thorough understanding of FDA and ICH quality regulations. Experience in Quality Systems Management is required. Excellent written and oral communication with exceptional organization and multitasking ability. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Provides overall leadership to the Specialty team. Responsible for all aspects of daily operations including profitability, expense control, buying, merchandising, labor, regulatory compliance, and special projects as assigned. Leads and develops Associate Team Leaders and Team Members. Accountable for Team Member hiring, development, corrective actions and separations. All Whole Foods Market Retail jobs require ensuring a positive company image by providing courteous, friendly, and efficient service to customers and Team Members at all times. All positions must be performed in accordance with team and store Standard Operating Procedures. Further, Team Members must be prepared and able to perform the duties inherent in other Team Member job descriptions. All positions must strive to support WFM core values and goals, promote national, regional, and store programs and initiatives, and ensure adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department. Job Responsibilities Holds ATLs, supervisors, and Team Members accountable for delivering outstanding customer service. Defines and develops clear expectations to achieve the highest standards of retail execution. Effectively delegates to and empowers ATLs and Team Members. Accountable for monitoring and achieving sales, margin, expense, and labor targets. Maintains proper product assortment, merchandising, and inventory control. Ensures products are cross-merchandised in accordance with regional and global guidelines. Ensures adherence to category management schedule and planograms. Ensures nutritional aspects are displayed correctly. Establishes and maintains collaborative and productive working relationship with departmental and store leadership. Maintains comprehensive knowledge of and ensures compliance with relevant regulatory rules and standards. Sets and achieves the highest standards of retail execution. Fosters and encourages a positive environment of outstanding teamwork, mutual respect, and exceptional morale. Maintains awareness of customer flows and needs and directs Team Members as necessary to satisfy and delight customers; responds promptly to customer needs and questions. Selects, trains, develops, mentors, motivates, and counsels Team Members in a manner that sustains a high-performance team and minimizes turnover. Communicates and maintains Team Member safety and security standards. Provides timely, thorough, and thoughtful performance evaluations. Consistently communicates and models WFM vision and goals. Job Skills Sustains exceptional level of knowledge and awareness of relevant competitors and industry trends. Advanced knowledge of products, buying, pricing, merchandising, and inventory management. Food safety certification. If not currently certified, will commit to completing certification within 6 months. Excellent interpersonal, motivational, team building, and customer relationship skills. Capable of teaching others in a positive and constructive manner. Thorough p roduct knowledge. Advanced knowledge of regulatory and safety policies and procedures. Proficient mathematical skills for assessing financial performance, monitoring profitability, and managing inventory. Demonstrated decision-making ability, leadership skills, and ability to prioritize and delegate. Proficiency with email, Microsoft Office, and operations-related applications. Experience 24+ months retail experience including 12+ months of team leadership experience. Physical Requirements / Working Conditions Must be able to lift 5 0 pounds. In an 8-hour work day: standing/walking 6-8 hours. Hand use: single grasping, fine manipulation, pushing and pulling. Work requires the following motions: bending, twisting, squatting and reaching. Exposure to FDA approved cleaning chemicals. Exposure to temperatures: 90 degrees Fahrenheit. Ability to work in a wet and cold environment . Ability to work a flexible schedule including nights, weekends, and holidays as needed . Ability to use tools and equipment, including box cutters, electric pallet jacks, and other heavy machinery . Where applicable, TIPS (Training for Intervention Procedures by Servers of Alcohol) course completion required and must be age 18 years of age or older to serve alcohol. Note : The purpose of this document is to provide a general summary of essential responsibilities for the position and is not meant as an exhaustive list. This document does not reflect all job duties or requirements for every position. Requirements build as one progresses through the job levels, so any job duties required at a lower level may be required at the higher level in addition to the duties listed for that higher level. Duties, assignments, and other responsibilities may differ for similar positions based on business conditions, departmental or geographic location, and/or needs for the particular position. An individual must demonstrate successful performance in their current position before being considered for promotion. In addition, in order to promote into a higher-level position, a business need for the promotion must exist and the candidate must be considered the most qualified person for the new position. Completion of certain milestones such as obtaining an advanced degree or certification, time in current position, or developing skills to perform at the higher-level role do not guarantee a promotion. At Whole Foods Market, we provide a fair and equal employment opportunity for all Team Members and candidates regardless of race, color, religion, national origin, gender, pregnancy, sexual orientation, gender identity/expression, age, marital status, disability, or any other legally protected characteristic. Whole Foods Market hires and promotes individuals solely based on qualifications for the position to be filled and business needs. Whole Foods Market works with job sites like Indeed, LinkedIn, and ZipRecruiter to promote opportunities at our company. Please be aware that other career sites may not be accurate or up to date and may even be fraudulent. We encourage and recommend all candidates to apply via our site.
05/15/2023
Full time
Provides overall leadership to the Specialty team. Responsible for all aspects of daily operations including profitability, expense control, buying, merchandising, labor, regulatory compliance, and special projects as assigned. Leads and develops Associate Team Leaders and Team Members. Accountable for Team Member hiring, development, corrective actions and separations. All Whole Foods Market Retail jobs require ensuring a positive company image by providing courteous, friendly, and efficient service to customers and Team Members at all times. All positions must be performed in accordance with team and store Standard Operating Procedures. Further, Team Members must be prepared and able to perform the duties inherent in other Team Member job descriptions. All positions must strive to support WFM core values and goals, promote national, regional, and store programs and initiatives, and ensure adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department. Job Responsibilities Holds ATLs, supervisors, and Team Members accountable for delivering outstanding customer service. Defines and develops clear expectations to achieve the highest standards of retail execution. Effectively delegates to and empowers ATLs and Team Members. Accountable for monitoring and achieving sales, margin, expense, and labor targets. Maintains proper product assortment, merchandising, and inventory control. Ensures products are cross-merchandised in accordance with regional and global guidelines. Ensures adherence to category management schedule and planograms. Ensures nutritional aspects are displayed correctly. Establishes and maintains collaborative and productive working relationship with departmental and store leadership. Maintains comprehensive knowledge of and ensures compliance with relevant regulatory rules and standards. Sets and achieves the highest standards of retail execution. Fosters and encourages a positive environment of outstanding teamwork, mutual respect, and exceptional morale. Maintains awareness of customer flows and needs and directs Team Members as necessary to satisfy and delight customers; responds promptly to customer needs and questions. Selects, trains, develops, mentors, motivates, and counsels Team Members in a manner that sustains a high-performance team and minimizes turnover. Communicates and maintains Team Member safety and security standards. Provides timely, thorough, and thoughtful performance evaluations. Consistently communicates and models WFM vision and goals. Job Skills Sustains exceptional level of knowledge and awareness of relevant competitors and industry trends. Advanced knowledge of products, buying, pricing, merchandising, and inventory management. Food safety certification. If not currently certified, will commit to completing certification within 6 months. Excellent interpersonal, motivational, team building, and customer relationship skills. Capable of teaching others in a positive and constructive manner. Thorough p roduct knowledge. Advanced knowledge of regulatory and safety policies and procedures. Proficient mathematical skills for assessing financial performance, monitoring profitability, and managing inventory. Demonstrated decision-making ability, leadership skills, and ability to prioritize and delegate. Proficiency with email, Microsoft Office, and operations-related applications. Experience 24+ months retail experience including 12+ months of team leadership experience. Physical Requirements / Working Conditions Must be able to lift 5 0 pounds. In an 8-hour work day: standing/walking 6-8 hours. Hand use: single grasping, fine manipulation, pushing and pulling. Work requires the following motions: bending, twisting, squatting and reaching. Exposure to FDA approved cleaning chemicals. Exposure to temperatures: 90 degrees Fahrenheit. Ability to work in a wet and cold environment . Ability to work a flexible schedule including nights, weekends, and holidays as needed . Ability to use tools and equipment, including box cutters, electric pallet jacks, and other heavy machinery . Where applicable, TIPS (Training for Intervention Procedures by Servers of Alcohol) course completion required and must be age 18 years of age or older to serve alcohol. Note : The purpose of this document is to provide a general summary of essential responsibilities for the position and is not meant as an exhaustive list. This document does not reflect all job duties or requirements for every position. Requirements build as one progresses through the job levels, so any job duties required at a lower level may be required at the higher level in addition to the duties listed for that higher level. Duties, assignments, and other responsibilities may differ for similar positions based on business conditions, departmental or geographic location, and/or needs for the particular position. An individual must demonstrate successful performance in their current position before being considered for promotion. In addition, in order to promote into a higher-level position, a business need for the promotion must exist and the candidate must be considered the most qualified person for the new position. Completion of certain milestones such as obtaining an advanced degree or certification, time in current position, or developing skills to perform at the higher-level role do not guarantee a promotion. At Whole Foods Market, we provide a fair and equal employment opportunity for all Team Members and candidates regardless of race, color, religion, national origin, gender, pregnancy, sexual orientation, gender identity/expression, age, marital status, disability, or any other legally protected characteristic. Whole Foods Market hires and promotes individuals solely based on qualifications for the position to be filled and business needs. Whole Foods Market works with job sites like Indeed, LinkedIn, and ZipRecruiter to promote opportunities at our company. Please be aware that other career sites may not be accurate or up to date and may even be fraudulent. We encourage and recommend all candidates to apply via our site.
Life Science People has partnered with a cutting edge Biotech who is focused on developing the next-generation of mRNA therapies. They are have recently received a large round of funding and for this reason, they are looking to scale their teams! Job Summary: We are seeking a highly motivated and experienced Senior Research Associate to join our team and lead the development of LNP (Lipid Nanoparticle) formulation for Insert product . The ideal candidate will have a strong background in pharmaceutical research and development with a focus on LNP formulation. Responsibilities: Lead the development of LNP formulation for Insert product with a focus on optimization of stability, drug loading, and release properties Design and execute in vitro and in vivo studies to evaluate the efficacy and safety of LNP formulations Collaborate with cross-functional teams, including Process Development, Analytical Development, and Manufacturing to bring LNP formulations from bench to clinical trials Write and review technical reports, protocols, and regulatory submissions Mentor and supervise junior researchers as needed Requirements: PhD in Pharmaceutical Sciences, Chemical Engineering, Materials Science or a related field with a focus on LNP formulation At least 5 years of industry experience in pharmaceutical research and development, with a focus on LNP formulation Strong understanding of the principles of LNP formulation, lipid nanoparticle engineering, and drug delivery Experience in designing and executing in vitro and in vivo studies Excellent written and verbal communication skills, as well as the ability to work in a cross-functional team Ability to lead and mentor junior researchers If you are passionate about cutting-edge research and development and have a strong background in LNP formulation, we would love to hear from you!
05/14/2023
Full time
Life Science People has partnered with a cutting edge Biotech who is focused on developing the next-generation of mRNA therapies. They are have recently received a large round of funding and for this reason, they are looking to scale their teams! Job Summary: We are seeking a highly motivated and experienced Senior Research Associate to join our team and lead the development of LNP (Lipid Nanoparticle) formulation for Insert product . The ideal candidate will have a strong background in pharmaceutical research and development with a focus on LNP formulation. Responsibilities: Lead the development of LNP formulation for Insert product with a focus on optimization of stability, drug loading, and release properties Design and execute in vitro and in vivo studies to evaluate the efficacy and safety of LNP formulations Collaborate with cross-functional teams, including Process Development, Analytical Development, and Manufacturing to bring LNP formulations from bench to clinical trials Write and review technical reports, protocols, and regulatory submissions Mentor and supervise junior researchers as needed Requirements: PhD in Pharmaceutical Sciences, Chemical Engineering, Materials Science or a related field with a focus on LNP formulation At least 5 years of industry experience in pharmaceutical research and development, with a focus on LNP formulation Strong understanding of the principles of LNP formulation, lipid nanoparticle engineering, and drug delivery Experience in designing and executing in vitro and in vivo studies Excellent written and verbal communication skills, as well as the ability to work in a cross-functional team Ability to lead and mentor junior researchers If you are passionate about cutting-edge research and development and have a strong background in LNP formulation, we would love to hear from you!
61644BRAuto req ID:61644BRJob Code:302058 Development Manager Department Office Location:USA - MA - Cambridge Business Title:Associate Director of Annual Giving & EngagementSub-Unit: Salary Grade ( ) :058Time Status:Full-time Union:00 - Non Union, Exempt or Temporary Basic Qualifications: + Bachelor's degree + Minimum of four years progressively responsible experience in fundraising and administration or related transferable experience. This experience must include: + strong project management experience involving managing multiple projects and priorities to meet aggressive timelines and challenging deadlines, + executing multi-channel annual giving efforts + leveraging strong data analysis to drive future strategies Additional Qualifications and Skills: + Experience in higher education or non-profit setting preferred + Superior interpersonal skills with proven ability to successfully interact and collaborate with varied constituencies in a professional manner, exhibiting excellent written and oral communication skills. + Proven track record of working in a dynamic, evolving, and highly energetic fundraising environment. + Ability to function at a high level within a complex organization. + Ability to apply good judgment and discretion when dealing with highly confidential alumni, family, donor, and prospect information + Experience working prospect tracking systems (BSR Advance) with Constituent Record Management (CRM) systems (SalesForce), email marketing systems, and social media platforms preferred. Additional Information: This position requires a six-month orientation and review period. Cover Letter: Please note that cover letters are required for every application for a position at the Radcliffe Institute. Please combine your cover letter and resume into a single document that is uploaded when you are instructed by HARVARD CAREERS, Harvard's online application program, to "Upload my resume/CV from my computer". COVID-19 Vaccination: Harvard requires COVID vaccination for all Harvard community members.Individuals may claim exemption from the vaccine requirement for medical or religious reasons. More information regarding the University's COVID vaccination requirement, exemptions, and verification of vaccination status may be found at the University's "COVID-19 Vaccine Information" webpage: . Interviews: We will be conducting interviews virtually for selected candidates until further notice and appreciate your understanding and flexibility with our interview process. About the Harvard Radcliffe Institute: The Harvard Radcliffe Institute is dedicated to creating and sharing transformative ideas across the arts, humanities, sciences, and social sciences. The Fellowship Program ( ) annually supports the work of 50 leading artists and scholars. Academic Ventures ( ) fosters collaborative research projects and sponsors lectures and conferences that engage scholars with the public. The Schlesinger Library ( ) documents the lives of American women of the past and present for the future, furthering the Institute's commitment to women, gender and society. We are proud to be an Affirmative Action/Equal Opportunity Employer and are committed to achieving our goals through the efforts of a highly skilled, diverse workforce. With outstanding benefits ( ) , competitive pay ( ) , extensive learning opportunities , ( ) and a stimulating and attractive work environment, the Radcliffe Institute for Advanced Study at Harvard University may be exactly the employer you have been looking for. Department:External RelationsPre-Employment Screening:Education, Employment, IdentityJob Function:Alumni Affairs and Development Position Description: + Directs oversight of the Institute's annual fund and direct marketing program, including setting and meeting annual Radcliffe Fund targets, using a data-driven approach to advance donor acquisition and retention to expand Radcliffe's donor base within target affiliate groups, and developing a long-term strategy for broad affiliate engagement to drive increased philanthropy to Radcliffe. + Drives all facets of direct marketing oversight and execution including content development, calendar management, budget oversight, appeal execution, department and vendor relationships, data analysis and acknowledgements. Partners closely with key stakeholders within the External Relations team as well as the Institute's Communications team and AA&D UBS colleagues. + Project manages all logistical elements toward appeal execution including data segmentation, data requests, ask amount strategy, A/B testing efforts, and tracking and managing membership in giving societies as well as direct marketing responses. + Monitors direct marketing outcomes (participation rates, response rate, cost-per-piece, appeal effectiveness, click- through, average gift, email metrics) to inform measures of success as well as opportunities for strategic improvement. Provides regular reporting and updates to department and Institute leadership. + Leverages strong communications skills to inform and draft content as well as to edit and proofread a variety of digital and print copy for annual giving and engagement pieces. + Develops innovative annual strategies for appeal letters, e-appeals, marketing, and outreach, including on-point messaging on Radcliffe's priorities. Works in strategic partnership with departmental colleague to create compelling messages and incorporate best practices in appeal writing. + In concert with the Director of Donor Engagement, formulates and executes strategic plans for Radcliffe's Giving Societies including Leadership Society, Associates and Ann Radcliffe Society. + Develops corresponding marketing materials. Monitors, analyzes, and reports monthly progress for the department and, as necessary, Institute and volunteer leadership. Works closely with the Senior Director, Major Gifts, to build processes and mechanisms to ensure current and potential Leadership Society ($5K+) donors are solicited, and overall participation continues to grow. + Proposes and advances creative fundraising initiatives, advancing Radcliffe's participation in the digital space and commitment to multimedia communication. + Manages the day-to-day business relationship with AA&D UBS, which provides contractual operational support for the department, to ensure effective execution and deployment of appeals, timely reporting, and opportunities for improvement. + Embodies the ideal of working in a university by supporting a culture of learning and growth. Seeks opportunities to learn and build skills as well as opportunities to help others to develop and grow. + Supports a culture of inclusion and diversity. Supervisory Responsibilities: + Supervises assigned staff. + Carries out supervisory responsibilities according to the Institute's / University's management policies, procedures, and applicable laws. + Responsibilities may include hiring and training, planning, and assigning work, conducting performance appraisals, addressing performance issues, and resolving problems. School/Unit:Harvard Radcliffe Institute EEO Statement:We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.Physical Requirements: The demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Employee must have the ability to sit at a desk for a minimum of seven hours a day and complete tasks requiring repetitive use of hands. + Occasional travel may be required. + This role is offered as a hybrid (some combination of onsite and remote) where the incumbent is required to be onsite at our Cambridge, MA location. Specific days and schedule will be determined between the incumbent and manager. + Must be able to travel frequently to meet with prospects and donors. + Able to work some nights and weekends as required Job Summary: The Harvard Radcliffe Institute ( ) (HRI) seeks a strategic, creative, and collaborative Associate Director of Annual Giving and Engagement to oversee annual fund and direct marketing strategy for the Radcliffe Fund. Reporting to the Director of Donor Engagement and working closely with the Associate Director of Donor Relations and Communications and the Donor Engagement Officer, the successful candidate will set the Institute's direct marketing and annual fund strategy to drive a continued expansion of donor participation and current-use leadership giving. Key to this work will be advancing the Institute's annual fund engagement strategy in alignment with the objectives set forth through the Institute's strategic plan Radcliffe Engaged. . click apply for full job details
05/14/2023
Full time
61644BRAuto req ID:61644BRJob Code:302058 Development Manager Department Office Location:USA - MA - Cambridge Business Title:Associate Director of Annual Giving & EngagementSub-Unit: Salary Grade ( ) :058Time Status:Full-time Union:00 - Non Union, Exempt or Temporary Basic Qualifications: + Bachelor's degree + Minimum of four years progressively responsible experience in fundraising and administration or related transferable experience. This experience must include: + strong project management experience involving managing multiple projects and priorities to meet aggressive timelines and challenging deadlines, + executing multi-channel annual giving efforts + leveraging strong data analysis to drive future strategies Additional Qualifications and Skills: + Experience in higher education or non-profit setting preferred + Superior interpersonal skills with proven ability to successfully interact and collaborate with varied constituencies in a professional manner, exhibiting excellent written and oral communication skills. + Proven track record of working in a dynamic, evolving, and highly energetic fundraising environment. + Ability to function at a high level within a complex organization. + Ability to apply good judgment and discretion when dealing with highly confidential alumni, family, donor, and prospect information + Experience working prospect tracking systems (BSR Advance) with Constituent Record Management (CRM) systems (SalesForce), email marketing systems, and social media platforms preferred. Additional Information: This position requires a six-month orientation and review period. Cover Letter: Please note that cover letters are required for every application for a position at the Radcliffe Institute. Please combine your cover letter and resume into a single document that is uploaded when you are instructed by HARVARD CAREERS, Harvard's online application program, to "Upload my resume/CV from my computer". COVID-19 Vaccination: Harvard requires COVID vaccination for all Harvard community members.Individuals may claim exemption from the vaccine requirement for medical or religious reasons. More information regarding the University's COVID vaccination requirement, exemptions, and verification of vaccination status may be found at the University's "COVID-19 Vaccine Information" webpage: . Interviews: We will be conducting interviews virtually for selected candidates until further notice and appreciate your understanding and flexibility with our interview process. About the Harvard Radcliffe Institute: The Harvard Radcliffe Institute is dedicated to creating and sharing transformative ideas across the arts, humanities, sciences, and social sciences. The Fellowship Program ( ) annually supports the work of 50 leading artists and scholars. Academic Ventures ( ) fosters collaborative research projects and sponsors lectures and conferences that engage scholars with the public. The Schlesinger Library ( ) documents the lives of American women of the past and present for the future, furthering the Institute's commitment to women, gender and society. We are proud to be an Affirmative Action/Equal Opportunity Employer and are committed to achieving our goals through the efforts of a highly skilled, diverse workforce. With outstanding benefits ( ) , competitive pay ( ) , extensive learning opportunities , ( ) and a stimulating and attractive work environment, the Radcliffe Institute for Advanced Study at Harvard University may be exactly the employer you have been looking for. Department:External RelationsPre-Employment Screening:Education, Employment, IdentityJob Function:Alumni Affairs and Development Position Description: + Directs oversight of the Institute's annual fund and direct marketing program, including setting and meeting annual Radcliffe Fund targets, using a data-driven approach to advance donor acquisition and retention to expand Radcliffe's donor base within target affiliate groups, and developing a long-term strategy for broad affiliate engagement to drive increased philanthropy to Radcliffe. + Drives all facets of direct marketing oversight and execution including content development, calendar management, budget oversight, appeal execution, department and vendor relationships, data analysis and acknowledgements. Partners closely with key stakeholders within the External Relations team as well as the Institute's Communications team and AA&D UBS colleagues. + Project manages all logistical elements toward appeal execution including data segmentation, data requests, ask amount strategy, A/B testing efforts, and tracking and managing membership in giving societies as well as direct marketing responses. + Monitors direct marketing outcomes (participation rates, response rate, cost-per-piece, appeal effectiveness, click- through, average gift, email metrics) to inform measures of success as well as opportunities for strategic improvement. Provides regular reporting and updates to department and Institute leadership. + Leverages strong communications skills to inform and draft content as well as to edit and proofread a variety of digital and print copy for annual giving and engagement pieces. + Develops innovative annual strategies for appeal letters, e-appeals, marketing, and outreach, including on-point messaging on Radcliffe's priorities. Works in strategic partnership with departmental colleague to create compelling messages and incorporate best practices in appeal writing. + In concert with the Director of Donor Engagement, formulates and executes strategic plans for Radcliffe's Giving Societies including Leadership Society, Associates and Ann Radcliffe Society. + Develops corresponding marketing materials. Monitors, analyzes, and reports monthly progress for the department and, as necessary, Institute and volunteer leadership. Works closely with the Senior Director, Major Gifts, to build processes and mechanisms to ensure current and potential Leadership Society ($5K+) donors are solicited, and overall participation continues to grow. + Proposes and advances creative fundraising initiatives, advancing Radcliffe's participation in the digital space and commitment to multimedia communication. + Manages the day-to-day business relationship with AA&D UBS, which provides contractual operational support for the department, to ensure effective execution and deployment of appeals, timely reporting, and opportunities for improvement. + Embodies the ideal of working in a university by supporting a culture of learning and growth. Seeks opportunities to learn and build skills as well as opportunities to help others to develop and grow. + Supports a culture of inclusion and diversity. Supervisory Responsibilities: + Supervises assigned staff. + Carries out supervisory responsibilities according to the Institute's / University's management policies, procedures, and applicable laws. + Responsibilities may include hiring and training, planning, and assigning work, conducting performance appraisals, addressing performance issues, and resolving problems. School/Unit:Harvard Radcliffe Institute EEO Statement:We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.Physical Requirements: The demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Employee must have the ability to sit at a desk for a minimum of seven hours a day and complete tasks requiring repetitive use of hands. + Occasional travel may be required. + This role is offered as a hybrid (some combination of onsite and remote) where the incumbent is required to be onsite at our Cambridge, MA location. Specific days and schedule will be determined between the incumbent and manager. + Must be able to travel frequently to meet with prospects and donors. + Able to work some nights and weekends as required Job Summary: The Harvard Radcliffe Institute ( ) (HRI) seeks a strategic, creative, and collaborative Associate Director of Annual Giving and Engagement to oversee annual fund and direct marketing strategy for the Radcliffe Fund. Reporting to the Director of Donor Engagement and working closely with the Associate Director of Donor Relations and Communications and the Donor Engagement Officer, the successful candidate will set the Institute's direct marketing and annual fund strategy to drive a continued expansion of donor participation and current-use leadership giving. Key to this work will be advancing the Institute's annual fund engagement strategy in alignment with the objectives set forth through the Institute's strategic plan Radcliffe Engaged. . click apply for full job details
The role: You will be working within a multidisciplinary team, supporting the next generation in sustainable and delicious food production. You'll help design the systems that enable our fermentation processes and aid in the scaling of our technology. This position is based in Cambridge, MA and offers a competitive salary, healthcare, and benefits. Your day-to-day will be to: Maintain a high standard of safety culture and design for safe operations, including designing for hydrogen safety. Design first-of-a-kind fermentation equipment and upgrade custom designs for further process improvements. Identify, specify, and procure the required equipment for optimization of fermentation and downstream processing. Manage the installation and commissioning of novel systems, including our next scale-up system. Aid in the design of commercial scale facilities and modeling for techno-economic analysis. You ideally have many of the following: Education in bioprocess engineering, process engineering, chemical engineering, mechanical engineering, fermentation, or adjacent fields. 6+ years of experience with equipment design, ideally with a focus on fermentation and sanitary design. Hands-on experience operating and working with industrial equipment and instrumentation. Experience troubleshooting complex problems or failures, such as equipment failures or control systems optimization. Comfortable with working with changing priorities as technical developments progress. About Circe: Deliciousness comes from fats. Chances your favorite foods derive their deliciousness in large part from fat. Whether they're making donuts fluffy, chocolate melt in your mouth, nuts and fruits healthy, or bacon crispy; fats are ubiquitous and vital to flavor, texture, and nutrition. But, we have a problem. Our environmental emergency is exacerbated by the current way we source and manufacture our favorite foods. Part of the problem is we don't want to give up the foods we love and have minimal adequate alternatives-either we eat the unsustainable foods we love, or we eat foods that are sustainable but lacking on the enjoyment. Using recent breakthroughs in biotechnology, we can change that. Circe is a food company founded on the belief that fats are magical, the future of food is fermentation, and that not only can delicious food be sustainable, it should be! Using proprietary technology invented at Harvard, Circe makes deliciousness sustainable by genetically engineering microbes to make fats from carbon dioxide. A few notes on what we value: While technology plays a significant role in Circe's mission, the larger project is one that involves purpose, accountability, and intentionality. The people we bring on are more valuable than the technologies we will build together. We want to inspire the ingenious, empower the thoughtful, and engage the hopeful. We believe that a clear-eyed, piercing look at what we face is the only way forward. And plan to do just that. Urgency with Care: We are in a race against time on multiple fronts, but we cannot let the urgency of the situation override care for each other, intention, and thoughtfulness. Mastery with Creativity : We are a team of scientists, engineers, and operators that value doing things right, well, and with rigor. We are also artists, athletes, and chefs and know that we can't stop there. It is after technical proficiency that the addition of creative and unorthodox thinking opens the doors of possibility. Conviction with Inclusion: We are building Circe because we have an unwavering conviction that what we're doing is important and can make a difference. However, our conviction must remain flexible and open to new information and ideas.
05/14/2023
Full time
The role: You will be working within a multidisciplinary team, supporting the next generation in sustainable and delicious food production. You'll help design the systems that enable our fermentation processes and aid in the scaling of our technology. This position is based in Cambridge, MA and offers a competitive salary, healthcare, and benefits. Your day-to-day will be to: Maintain a high standard of safety culture and design for safe operations, including designing for hydrogen safety. Design first-of-a-kind fermentation equipment and upgrade custom designs for further process improvements. Identify, specify, and procure the required equipment for optimization of fermentation and downstream processing. Manage the installation and commissioning of novel systems, including our next scale-up system. Aid in the design of commercial scale facilities and modeling for techno-economic analysis. You ideally have many of the following: Education in bioprocess engineering, process engineering, chemical engineering, mechanical engineering, fermentation, or adjacent fields. 6+ years of experience with equipment design, ideally with a focus on fermentation and sanitary design. Hands-on experience operating and working with industrial equipment and instrumentation. Experience troubleshooting complex problems or failures, such as equipment failures or control systems optimization. Comfortable with working with changing priorities as technical developments progress. About Circe: Deliciousness comes from fats. Chances your favorite foods derive their deliciousness in large part from fat. Whether they're making donuts fluffy, chocolate melt in your mouth, nuts and fruits healthy, or bacon crispy; fats are ubiquitous and vital to flavor, texture, and nutrition. But, we have a problem. Our environmental emergency is exacerbated by the current way we source and manufacture our favorite foods. Part of the problem is we don't want to give up the foods we love and have minimal adequate alternatives-either we eat the unsustainable foods we love, or we eat foods that are sustainable but lacking on the enjoyment. Using recent breakthroughs in biotechnology, we can change that. Circe is a food company founded on the belief that fats are magical, the future of food is fermentation, and that not only can delicious food be sustainable, it should be! Using proprietary technology invented at Harvard, Circe makes deliciousness sustainable by genetically engineering microbes to make fats from carbon dioxide. A few notes on what we value: While technology plays a significant role in Circe's mission, the larger project is one that involves purpose, accountability, and intentionality. The people we bring on are more valuable than the technologies we will build together. We want to inspire the ingenious, empower the thoughtful, and engage the hopeful. We believe that a clear-eyed, piercing look at what we face is the only way forward. And plan to do just that. Urgency with Care: We are in a race against time on multiple fronts, but we cannot let the urgency of the situation override care for each other, intention, and thoughtfulness. Mastery with Creativity : We are a team of scientists, engineers, and operators that value doing things right, well, and with rigor. We are also artists, athletes, and chefs and know that we can't stop there. It is after technical proficiency that the addition of creative and unorthodox thinking opens the doors of possibility. Conviction with Inclusion: We are building Circe because we have an unwavering conviction that what we're doing is important and can make a difference. However, our conviction must remain flexible and open to new information and ideas.
Summary The Education Specialist will provide a broad range of educational, research, content development and digital-media production support to the Science Education Department (SED) of the Smithsonian Astrophysical Observatory, which is dedicated to improving STEM education and to increasing public interest in and understanding of core science concepts related to astronomical research. Responsibilities The primary responsibility of the education specialist will include supporting SED's research and development of programs for youth, educators, and public audiences that engage learners in using SAO's MicroObservatory online telescopes. Additional responsibilities include contributing to research and evaluation data collection and analysis activities for SED education projects. Duties: Provide educational and content support to the SAO's informal and formal education projects, including web, library, and image research on topics related to observational astronomy and astrophysics, and the preparation of interpretive and informational materials to be used in both digital and print media for diverse public and K-12 audiences, and communication, outreach, and dissemination of the projects. Inform and implement social media efforts on our web-based projects, including regular updates on Facebook, Twitter, etc., with the potential to guide these efforts. Create and coordinate written and digital media astronomy and science education materials, including web content and features, flyers, educational briefs, video tutorials, and newsletters. Contributes to the writing, editing, and design processes of educational media, publications, and other interpretive materials. Research, develop, and produce media, content briefs and draft interpretive text to give instructions, provide context, and explain the scientific subject matter to diverse public and classroom audiences. Conduct simple audio and video planning and production, editing, post-production, and media management tasks. Guide logistics and assist with the development and implementation of educational programs and products for both adult and youth audiences (in both online and face-to-face settings). Apply knowledge of the science education needs of diverse audiences to make appropriate content and programming decisions. Coordinate the review of draft and final products with the subject matter and education specialists and clients. Assist with the development and dissemination of educational activities, such as hands-on and online telescope investigations and interactive or online computer activities, through research, logistical support, evaluation data collection, and other assistance. Proofread and edit curriculum and online content with an eye for detail. Assist with evaluation and documentation of SED projects, including assistance with the analysis of participant data and coordination of text and media-based materials for written, online, and video-based case studies of the projects. Conduct image and copyright research and materials/artifact acquisition for SED projects. Monitor and document appropriate copyright status and credit assignments for all materials and maintain databases of images and artifacts. Use image processing software to prepare images for the best scientific and educational effectiveness. Contact and communicate with scientists to coordinate their participation in education and outreach programs and identify resources for educational projects. Establish and maintain active communication with educators, scientists, contractors, and media personnel within and outside of SAO to share information about the status of the SED projects. Some travel for conferences, meetings with project partners, and potential museum venues may be required. Performs other duties as required. Requirements Conditions of Employment Travel may be required. May be required to serve a one-year probationary period. Pre- and post-appointment background investigation. For the latest information on the COVID-19 vaccination requirements and its impact on your application, click on Smithsonian Institution's Frequently Asked Questions. Qualifications All applicants must meet these Basic Education Requirements: A. Degree: that included or was supplemented by major study in science education or in a subject-matter field appropriate to the position. OR Combination of education and experience courses equivalent to a major in education, or in a subject-matter field appropriate to the position, plus appropriate experience or additional course work that provided knowledge comparable to that normally acquired through the successful completion of the 4-year course of study described in A above. In addition to meeting the basic education requirements, applicants must meet the following criteria to qualify for the grade level specified. Experience: One year of full-time experience at the GS-07 level that is close or similar to the work of this job. The experience includes activities such as implementing science learning programs for classroom or out of school audiences. Education: Two full years of progressively higher level graduate education leading to a master's or equivalent degree in education or a field related to the position may be substituted for the required experience. Part-time and/or unpaid experience related to this position will be considered to determine the total number of years and months of experience. Be sure to note the number of paid or unpaid hours worked each week. Education Additional Information For information on qualification requirements, see Qualification Standards Handbook for General Schedule Positions viewable on the web at
05/13/2023
Full time
Summary The Education Specialist will provide a broad range of educational, research, content development and digital-media production support to the Science Education Department (SED) of the Smithsonian Astrophysical Observatory, which is dedicated to improving STEM education and to increasing public interest in and understanding of core science concepts related to astronomical research. Responsibilities The primary responsibility of the education specialist will include supporting SED's research and development of programs for youth, educators, and public audiences that engage learners in using SAO's MicroObservatory online telescopes. Additional responsibilities include contributing to research and evaluation data collection and analysis activities for SED education projects. Duties: Provide educational and content support to the SAO's informal and formal education projects, including web, library, and image research on topics related to observational astronomy and astrophysics, and the preparation of interpretive and informational materials to be used in both digital and print media for diverse public and K-12 audiences, and communication, outreach, and dissemination of the projects. Inform and implement social media efforts on our web-based projects, including regular updates on Facebook, Twitter, etc., with the potential to guide these efforts. Create and coordinate written and digital media astronomy and science education materials, including web content and features, flyers, educational briefs, video tutorials, and newsletters. Contributes to the writing, editing, and design processes of educational media, publications, and other interpretive materials. Research, develop, and produce media, content briefs and draft interpretive text to give instructions, provide context, and explain the scientific subject matter to diverse public and classroom audiences. Conduct simple audio and video planning and production, editing, post-production, and media management tasks. Guide logistics and assist with the development and implementation of educational programs and products for both adult and youth audiences (in both online and face-to-face settings). Apply knowledge of the science education needs of diverse audiences to make appropriate content and programming decisions. Coordinate the review of draft and final products with the subject matter and education specialists and clients. Assist with the development and dissemination of educational activities, such as hands-on and online telescope investigations and interactive or online computer activities, through research, logistical support, evaluation data collection, and other assistance. Proofread and edit curriculum and online content with an eye for detail. Assist with evaluation and documentation of SED projects, including assistance with the analysis of participant data and coordination of text and media-based materials for written, online, and video-based case studies of the projects. Conduct image and copyright research and materials/artifact acquisition for SED projects. Monitor and document appropriate copyright status and credit assignments for all materials and maintain databases of images and artifacts. Use image processing software to prepare images for the best scientific and educational effectiveness. Contact and communicate with scientists to coordinate their participation in education and outreach programs and identify resources for educational projects. Establish and maintain active communication with educators, scientists, contractors, and media personnel within and outside of SAO to share information about the status of the SED projects. Some travel for conferences, meetings with project partners, and potential museum venues may be required. Performs other duties as required. Requirements Conditions of Employment Travel may be required. May be required to serve a one-year probationary period. Pre- and post-appointment background investigation. For the latest information on the COVID-19 vaccination requirements and its impact on your application, click on Smithsonian Institution's Frequently Asked Questions. Qualifications All applicants must meet these Basic Education Requirements: A. Degree: that included or was supplemented by major study in science education or in a subject-matter field appropriate to the position. OR Combination of education and experience courses equivalent to a major in education, or in a subject-matter field appropriate to the position, plus appropriate experience or additional course work that provided knowledge comparable to that normally acquired through the successful completion of the 4-year course of study described in A above. In addition to meeting the basic education requirements, applicants must meet the following criteria to qualify for the grade level specified. Experience: One year of full-time experience at the GS-07 level that is close or similar to the work of this job. The experience includes activities such as implementing science learning programs for classroom or out of school audiences. Education: Two full years of progressively higher level graduate education leading to a master's or equivalent degree in education or a field related to the position may be substituted for the required experience. Part-time and/or unpaid experience related to this position will be considered to determine the total number of years and months of experience. Be sure to note the number of paid or unpaid hours worked each week. Education Additional Information For information on qualification requirements, see Qualification Standards Handbook for General Schedule Positions viewable on the web at