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Senior Manager, Regulatory Affairs Advertising and Promotion
Sanofi Cambridge, Massachusetts
09/22/2023
Full time
Position Overview With minimal direction from the Sr. Director or AVP, will conduct the independent review of advertising, promotional, medical, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches. As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects. Mentor less experienced A&P reviewers to help develop talent within the team. Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters. Key Responsibilities Identifies product specific or therapeutic area A&P issues and works with other teams to propose and implement solutions. Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters. Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision. Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively. Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs. Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications. Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders. Performs other duties as assigned. Basic Qualifications Bachelor's degree in Life Sciences from an accredited four-year college or university. Work Experience Required 2-5 Years experience in the following areas: Experience within pharmaceutical or medical device Regulatory Affairs. Successful track record with ideally 2-5 years relevant regulatory advertising and promotion experience. Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc. Knowledge, Skills and Equivalent Experience Knowledge and understanding of complex medical and scientific subject matter. Ability to work well within cross-functional teams. Demonstrates solid oral communication and writing skills. Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology. Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution. Develops collaborative relationships to facilitate the accomplishment of work goals. Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities. Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans. Can build networks to obtain cooperation. Unquestionable ethics, professional integrity and personal values consistent with the Sanofi-Aventis values. Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed. Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well. Deals with people in an honest and forthright manner representing information and data accurately. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. 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.
2 Years Fixed Term Life Science Research Professional 2
Stanford University Stanford, California
09/22/2023
Full time
The Stanford Brain Organogenesis and The Department of Psychiatry and Behavioral Sciences at Stanford University School of Medicine is currently recruiting a highly motivated Research Scientist (Life Science Research Professional 2) to join Dr. Sergiu Pasca ' s research program. Our Stanford research team seeks to understand the rules that govern the molecular and cellular steps underlying the assembly of the human brain and the molecular mechanisms that lead to neurodevelopmental and neurodegenerative disorders. We are developing bottom-up approaches to generate and assemble, from multi-cellular components, human neural circuits. More specifically, we have pioneered the generation from human pluripotent stem cells of brain region-specific organoids ( Nature Methods 2015; Neuron 2017; Nature Methods 2019; Nature Neuroscience 2019) and assembloids ( Nature 2017; Nature Biotechnology 2020; Cell 2020), which we applied to gain mechanistic insights into disease ( Nature Medicine 2018; Nature Medicine 2020). Our ultimate goal is to identify novel and reliable drug targets for neuropsychiatric disorders. The candidate for this position will join an enthusiastic and multi-disciplinary team at Stanford, and should ideally have experience with human stem cells, neural differentiation, primary tissue culture or assay development and high-throughput screens. For more information on the Pasca lab and research being performed please visit their website at . Duties include: Independently conduct a portion of the research project(s) related to building brain organoid and assembloid models. Make recommendations on experimental design and/or research direction to principal investigator. Independently conduct experiments (cell culture, assay, screens) to gather data for a portion of a major research project. Interpret and analyze results, often where few guidelines exist, and make modifications to existing procedures and protocols. Participate in multidisciplinary teams across different faculties or schools. Perform ongoing literature review to remain current with new procedures and related research; apply to ongoing research and development of new protocols. Contribute substantively to the preparation of papers for publication, especially in the results section, and to publication of findings. Present ongoing work to colleagues and/or academic conferences. Oversee supply and equipment budget under supervision of principal investigator or business manager. Work with health and safety department to ensure lab complies with regulations and all required trainings. Supervise (either formally or informally) staff or students as needed, including oversight and direction on techniques, as well as consultation on project work. Serve as a technical resource for other research staff. Oversee the daily activities of the laboratory including lab maintenance; maintain lab stock, manage chemical inventory and safety records, and provide general lab support as needed. May assist with purchasing laboratory equipment. - Other duties may also be assigned DESIRED QUALIFICATIONS: Knowledge and experience with neurobiology, stem cell biology, molecular biology techniques and cellular assays EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in related scientific field and two years of relevant work experience; or Master's degree in a related scientific field. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Comprehensive understanding of scientific principles. General computer skills and ability to quickly learn and master computer programs, databases, and scientific applications. Strong analytical skills and excellent judgment. Ability to maintain detailed records of experiments and outcomes. Ability to work under deadlines with general guidance is essential. Excellent organizational skills and demonstrated ability to accurately complete detailed work. PHYSICAL REQUIREMENTS : Frequently stand, walk, twist, bend, stoop, squat, grasp lightly, use fine manipulation, grasp forcefully, perform desk-based computer tasks, use telephone, write by hand, lift, carry, push and pull objects weighing over 40 pounds. Occasionally sit, kneel, crawl, reach and work above shoulders, sort and file paperwork or parts. Rarely climb, scrub, sweep, mop, chop and mix or operate hand and foot controls. Must have correctible vision to perform duties of the job. Ability to bend, squat, kneel, stand, reach above shoulder level, and move on hard surfaces for up to eight hours. Ability to lift heavy objects weighing up to 50 pounds. Ability to work in a dusty, dirty, and odorous environment. Position may require repetitive motion. - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: May require working in close proximity to blood borne pathogens. May require work in an environment where animals are used for teaching and research. Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present. Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator. May require extended or unusual work hours based on research requirements and business needs. WORK STANDARDS: Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors bases on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, . The expected pay range for this position is $67,000 to $88,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.
Life Science Research Professional 2
Stanford University Stanford, California
09/21/2023
Full time
The Gibson Laboratory within the Department of Psychiatry and Behavioral Sciences at Stanford University's School of Medicine is seeking a Life Science Research Professional 2 (LSRP 2) to perform more complex functions and activities involved in defined research projects, and independently conduct a portion of the research project(s). Duties include: Independently conduct a portion of the research project(s). Make recommendations on experimental design and/or research direction to principal investigator. Independently conduct complex (lab and/or field) experiments to gather data for a portion of a major research project. Interpret and analyze results, often where few guidelines exist, and make modifications to existing procedures and protocols. Develop new research protocols where appropriate protocols are not described in the literature or where modification or adaptation of standard procedures and protocols is required. Participate in multidisciplinary teams across different faculties or schools. Perform ongoing literature review to remain current with new procedures and related research; apply to ongoing research and development of new protocols. Contribute substantively to the preparation of papers for publication, especially in the results section, and to publication of findings. Present ongoing work to colleagues and/or academic conferences. Oversee supply and equipment budget under supervision of principal investigator or business manager. Work with health and safety department to ensure lab complies with regulations and all required trainings. Supervise (either formally or informally) staff or students as needed, including oversight and direction on techniques, as well as consultation on project work. Serve as a technical resource for other research staff. Oversee the daily activities of the laboratory including lab maintenance; maintain lab stock, manage chemical inventory and safety records, and provide general lab support as needed. May assist with purchasing laboratory equipment. .- Other duties may also be assigned DESIRED QUALIFICATIONS: Degree in neuroscience, neurobiology, biology or similar field 2+ year of work experience in a basic science laboratory. Expertise in mouse EEG/EMG sleep recording. Prior experience with diverse experimental techniques including microscopy, immunohistochemistry, tissue sectioning, PCR, genotyping, maintenance of transgenic mice lines. General understanding of scientific principles. General computer skills and ability to quickly learn and master computer programs, databases, and scientific applications. Excellent interpersonal and communication abilities. Excellent organizational skills and demonstrated ability to accurately complete detailed work. Demonstrate aptitude in foresight, planning, and ability to organize as required by research. EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in related scientific field and two years of relevant work experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Comprehensive understanding of scientific principles. General computer skills and ability to quickly learn and master computer programs, databases, and scientific applications. Strong analytical skills and excellent judgment. Ability to maintain detailed records of experiments and outcomes. Ability to work under deadlines with general guidance is essential. Excellent organizational skills and demonstrated ability to accurately complete detailed work. PHYSICAL REQUIREMENTS*: Frequently stand, walk, twist, bend, stoop, squat, grasp lightly, use fine manipulation, grasp forcefully, perform desk-based computer tasks, use telephone, write by hand, lift, carry, push and pull objects weighing over 40 pounds. Occasionally sit, kneel, crawl, reach and work above shoulders, sort and file paperwork or parts. Rarely climb, scrub, sweep, mop, chop and mix or operate hand and foot controls. Must have correctible vision to perform duties of the job. Ability to bend, squat, kneel, stand, reach above shoulder level, and move on hard surfaces for up to eight hours. Ability to lift heavy objects weighing up to 50 pounds. Ability to work in a dusty, dirty, and odorous environment. Position may require repetitive motion. .- Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: May require working in close proximity to blood borne pathogens. May require work in an environment where animals are used for teaching and research. Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present. Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator. May require extended or unusual work hours based on research requirements and business needs. The expected pay range for this position is $67,000 to $88,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.
Study Lead Statistician - Product Facing
ACtalent Thousand Oaks, California
09/21/2023
Full time
The Study Lead Statistician SLS for product facing work is responsible for leading statistical activities of clinical studies. The SLS works closely with cross-functional team members to ensure their clinical studies are appropriately planned have the required statistical power for success comply with Regulatory requirements and company standards and maintain statistical as well as operational integrity throughout the life of the study. The SLS works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy. The SLS also works closely with the Study Statistician who performs all the operational activities related to the statistics-related deliverables. The SLS is responsible for the integrity and quality of their study. The SLS also supports product level activities that could include Regulatory activities as well as publication work. Core Responsibilities: Provide statistical guidance review and contribution to protocols SAPs TFL shells DMC Charters SDF specifications SDTM and ADaM randomization specifications other key-study related documentation protocol deviations data quality review and other communications Attend and be a contributor at Clinical Study Team Meetings Attend meetings for and provide statistical input into cross-functional study start-up activities including but not limited to CRF development database specifications review database development IVRS specification review Initiate cross-functional team meetings as necessary e.g. SAP review TFL shell review TFL review Provide statistical guidance review and be responsible for statistical analysis of individual studies/projects Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints programmatically Perform data-driven modeling during clinical studies Coordinate the creation of required outputs for Dose Level Review Meetings DLRMs as well as coordinate and participate in the DLRM Review TFLs created by statistical programming for consistency and accuracy Author analysis reports such as Flash Memo and results section of the CSRs Collaborate with the study programming team for study deliverables Manage timelines for all statistics-related deliverables by working with the cross-functional team members e.g. programmers study statisticians clinical data managers medical writer. Be familiar with all Companys policies SOPs and other controlled documents related to study activities noted above Assist with study and systems audits conducted by Company GCA and external bodies Minimum Education Required: Masters degree in Statistics/Biostatistics or other subject with high statistical content with at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research or PhD degree with at least 3 years' experience Strong skill in communicating statistical information clearly and concisely written and oral Strong understanding of statistical concepts related to the design and conduct of clinical studies Strong ability to apply statistical methodologies in the analysis of clinical trials Independent leadership of the design analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry Government or Academia Previous experience in the development author and execution of protocols and SAPs as well as review of CSRs Excellent oral and written English communication skills Strong SAS and/or R programming skills in conducting simulations and applying statistical concepts and methods based on complex study designs Preferred Qualifications: Masters degree in Statistics/Biostatistics or other subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics or other subject with high statistical content and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research Designing analyzing and reporting of clinical trials within Pharmaceutical/Biotechnology/Public Health setting in Industry Government or Academia Demonstrated ability in presenting results and defending statistical findings study design and analysis to internal audiences study/product team AND at external meetings such as investigator meetings steering committee meetings ad board meetings or regulatory meetings Leadership of at least 3 clinical studies/projects end-to-end with minimal oversight Life Cycle Drug Development Experience Pre-clinical Development Clinical Development and Post-marketing Demonstrated ability to work in cross-functional teams ideally including projects focused on delivering business solutions working with clinical development colleagues in study management programming and IS Demonstrated ability to influence decision making Experience in adaptive clinical trials and innovative study designs Experience in the utilization of Bayesian statistics in clinical trials Proficient R programming skills conducting simulations and applying statistical concepts and methods based on complex study designs Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Regulatory Affairs Manager
ACtalent Chicago, Illinois
09/20/2023
Full time
Description: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes. This person is instrumental in the design, development, and maintenance of global regulatory processes and business solutions. This is a meaningful individual contributor who will partner with key business, functional and business partners to ensure commercial objectives are achieved. Job Duties: Accountable for all operational aspects including owning, creating and/or maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes that support therapeutic and combination products. Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled process and systems workflows; lead reviews and manage the documents through approvals and governance by cross-functional executive and subject matter authority leadership. Make decisions regarding patient safety signals, indications, risk and other sophisticated change or regulated content creation/modification triggers. Support global implementation of CCDS/CCSI/RSI into country-specific labeling by developing and approving implementation of complex global and local labeling and other regulated solutions in accordance with the end-to-end regulated content, labeling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals. Participate in the execution of regulatory labeling and content strategies for new products and ongoing compliance for products already on the market, including monitoring, evaluating, and internally communicating new and existing applicable regulatory requirements. Lead or support global technology, process, and solution initiatives to standardize, and enable standard process in labeling and content management, including requirements, use cases and translations. Deliver responses, solutions, and find opportunities to improve based upon quality initiatives, including audits and risk mitigation. Perform gap analysis on regulated content management processes; design, develop, assess, improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions. Additional Skills & Qualifications: Bachelors degree in pharmacy, biochemistry or similar science related field preferred. Experience writing and managing Company Core Data Sheets Minimum 5 years of pharmaceutical regulatory or regulated content management (e.g., labeling, or Company Core Data Sheets) experience. Ability to run sophisticated projects and timelines in a matrix team environment. Strong project management and organizational skills. Ability to independently identify compliance risks and raise when necessary. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.