Job Description Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB). Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
03/28/2024
Full time
Job Description Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB). Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Job Description Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB). Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
03/28/2024
Full time
Job Description Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB). Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Job Description Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB). Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
03/28/2024
Full time
Job Description Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB). Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Description Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Responsibilities: Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training. In cooperation with affiliate medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. Drive Medical Affairs strategies and be a key internal contact/subject matter expert. May develop of scientifically accurate marketing materials, medical education programs, advisories, and symposia. May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. May oversee the work of Assistant/Associate Scientific Directors May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Provides guidance to cross-functional team members to aid in the development of promotional materials. Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)
03/28/2024
Full time
Job Description Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Responsibilities: Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training. In cooperation with affiliate medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. Drive Medical Affairs strategies and be a key internal contact/subject matter expert. May develop of scientifically accurate marketing materials, medical education programs, advisories, and symposia. May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. May oversee the work of Assistant/Associate Scientific Directors May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Provides guidance to cross-functional team members to aid in the development of promotional materials. Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)
Job Description The Associate Director, Business Unit Communications and Public Affairs - Gastroenterology is an opportunity for an entrepreneurial-minded, media savvy, passionate communicator to lead the strategy and execution of all external communications programs that advance AbbVie's award-winning gastroenterology portfolio. The Associate Director must be a strategic thinker and execute flawlessly while managing a broad range of internal and external stakeholders across mid-to-high levels of management. The Associate Director reports to the Director, Business Unit Communications and Public Affairs, Immunology. This role collaborates with functions across the organization, including Commercial Leadership, Medical Affairs, Regulatory Affairs, Corporate Communications, Research and Development Communications, and International Public Affairs colleagues to identify and maximize opportunities. RESPONSIBILITIES Develops strategic, high-impact public affairs programs to advance business objectives with emphasis on competitive differentiation, analytics, and the external environment. Secures timely buy-in and input from functional and franchise leaders on Public Affairs programs, including securing budget to effectively execute programs. Oversees and implements tactical program elements, ensuring deliverables are met on time and on budget across paid, earned, shared, and owned channels. Serves as communications advisor to franchise, ensuring programs are creatively developed and executed with the external environment in mind. Represents Business Unit Communications and Public Affairs on Integrated Brand Teams and proactively contributes to decision making settings with cross-functional business partners. Develops and maintains relationships on behalf of AbbVie with patient advocates and advocacy organizations. Demonstrates strong understanding of U.S. media environment and has media relations experience and skills to ensure effective engagement with reporters. Manages issues that affect the business overall by proactively anticipating and mitigating reputational risk to AbbVie and immunology brands. Drives agency partner performance and ensures effective use of AbbVie resources. Ensures compliance by managing review process for external communications materials (press releases, statements, response documents, fact sheets, etc.). Keep various parties apprised of status, timelines, and directional shifts to ensure smooth review process and to meet corporate deadlines. Consistently shares best practices and offers new ideas and thoughts to raise the bar for the Business Unit Communications team.
03/28/2024
Full time
Job Description The Associate Director, Business Unit Communications and Public Affairs - Gastroenterology is an opportunity for an entrepreneurial-minded, media savvy, passionate communicator to lead the strategy and execution of all external communications programs that advance AbbVie's award-winning gastroenterology portfolio. The Associate Director must be a strategic thinker and execute flawlessly while managing a broad range of internal and external stakeholders across mid-to-high levels of management. The Associate Director reports to the Director, Business Unit Communications and Public Affairs, Immunology. This role collaborates with functions across the organization, including Commercial Leadership, Medical Affairs, Regulatory Affairs, Corporate Communications, Research and Development Communications, and International Public Affairs colleagues to identify and maximize opportunities. RESPONSIBILITIES Develops strategic, high-impact public affairs programs to advance business objectives with emphasis on competitive differentiation, analytics, and the external environment. Secures timely buy-in and input from functional and franchise leaders on Public Affairs programs, including securing budget to effectively execute programs. Oversees and implements tactical program elements, ensuring deliverables are met on time and on budget across paid, earned, shared, and owned channels. Serves as communications advisor to franchise, ensuring programs are creatively developed and executed with the external environment in mind. Represents Business Unit Communications and Public Affairs on Integrated Brand Teams and proactively contributes to decision making settings with cross-functional business partners. Develops and maintains relationships on behalf of AbbVie with patient advocates and advocacy organizations. Demonstrates strong understanding of U.S. media environment and has media relations experience and skills to ensure effective engagement with reporters. Manages issues that affect the business overall by proactively anticipating and mitigating reputational risk to AbbVie and immunology brands. Drives agency partner performance and ensures effective use of AbbVie resources. Ensures compliance by managing review process for external communications materials (press releases, statements, response documents, fact sheets, etc.). Keep various parties apprised of status, timelines, and directional shifts to ensure smooth review process and to meet corporate deadlines. Consistently shares best practices and offers new ideas and thoughts to raise the bar for the Business Unit Communications team.
Job Description Description - External Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions, delivering scientific communications and driving results. This position can be based out of Irvine, CA or Marlow, UK. What Your New Manager Wants You To Know The Associate Director / Director, Global Body Contouring, Global Aesthetics Medical Affairs (GAMA) is a key strategic leader in the GAMA organization. Working under the leadership of the Executive Medical Director, Global Body Contouring, GAMA in partnership with key medical functional teams; the Associate Director / Director will assist in the development and implementation of comprehensive medical strategies for specific medical devices / products within the Body Contouring aesthetics portfolio. The Associate Director / Director must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regional regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. YOU ARE more than just a title, YOU ARE A global strategic thinker: align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive. First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will Strategic and Tactical Planning Develop and implement GAMA Global Body Contouring strategic and tactical plans. P articipate in pre-launch, launch and post-launch strategic decisions and delivery of medical tactics alongside providing medical expertise and scientific support to cross functional stakeholders. Measure and communicate progress on medical project milestones. Ensure alignment of medical functional teams supporting the Global Body Contouring strategic and tactical plans. Provide TA specific strategic guidance to the Global Body Contouring Medical Science Liaisons (MSLs). Lead on planning for and execution of medical advisory boards to inform current and future Allergan Aesthetic / AbbVie Medical Aesthetic strategic decisions. Contribute to commercial planning by leveraging medical/scientific expertise, knowledge of scientific data and understanding of the external healthcare environment. Advice and support commercial colleagues in the development of their marketing plans and scientific materials. Medical and Scientific Data Generation and Communication Under guidance from GAMA leadership, help develop and execute data generation plans (e.g. Phase 4) to provide post marketing data that supports the Body Contouring portfolio. Collaborate with the Global Scientific Communications team to contribute to robust Body Contouring publication plans. Collaborate with GAMA team members to identify key scientific content needed for field MSL teams. Internal and External Relationships Establish and maintain internal organizational links with the broader R&D, commercial and other Allergan Aesthetics / AbbVie departments to ensure appropriate support for GAMA. Establish and maintain relationships with top tier external experts in aesthetics to establish a strong scientific presence in the clinical and academic communities. Collaborate with the MSL teams to ensure external expert development and communication is optimized. Collaborate with Health Economic and Outcomes Research (HEOR) team to establish scientific and clinical credibility for clinical outcomes focused on patient reported outcomes. Assess support of external IIS proposals and concepts related to Body Contouring to ensure alignment with IIS priorities. Deliver portfolio-related clinical presentations as needed and participate in prioritized scientific congresses. Collect HCP and MSL insights to inform Allergan Aesthetics / AbbVie strategy (e.g. via advisory boards, strategic insights, field insight discussions).
03/28/2024
Full time
Job Description Description - External Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions, delivering scientific communications and driving results. This position can be based out of Irvine, CA or Marlow, UK. What Your New Manager Wants You To Know The Associate Director / Director, Global Body Contouring, Global Aesthetics Medical Affairs (GAMA) is a key strategic leader in the GAMA organization. Working under the leadership of the Executive Medical Director, Global Body Contouring, GAMA in partnership with key medical functional teams; the Associate Director / Director will assist in the development and implementation of comprehensive medical strategies for specific medical devices / products within the Body Contouring aesthetics portfolio. The Associate Director / Director must conduct their work activities in compliance with all AbbVie internal requirements and with all applicable regional regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements, and objectives. YOU ARE more than just a title, YOU ARE A global strategic thinker: align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive. First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will Strategic and Tactical Planning Develop and implement GAMA Global Body Contouring strategic and tactical plans. P articipate in pre-launch, launch and post-launch strategic decisions and delivery of medical tactics alongside providing medical expertise and scientific support to cross functional stakeholders. Measure and communicate progress on medical project milestones. Ensure alignment of medical functional teams supporting the Global Body Contouring strategic and tactical plans. Provide TA specific strategic guidance to the Global Body Contouring Medical Science Liaisons (MSLs). Lead on planning for and execution of medical advisory boards to inform current and future Allergan Aesthetic / AbbVie Medical Aesthetic strategic decisions. Contribute to commercial planning by leveraging medical/scientific expertise, knowledge of scientific data and understanding of the external healthcare environment. Advice and support commercial colleagues in the development of their marketing plans and scientific materials. Medical and Scientific Data Generation and Communication Under guidance from GAMA leadership, help develop and execute data generation plans (e.g. Phase 4) to provide post marketing data that supports the Body Contouring portfolio. Collaborate with the Global Scientific Communications team to contribute to robust Body Contouring publication plans. Collaborate with GAMA team members to identify key scientific content needed for field MSL teams. Internal and External Relationships Establish and maintain internal organizational links with the broader R&D, commercial and other Allergan Aesthetics / AbbVie departments to ensure appropriate support for GAMA. Establish and maintain relationships with top tier external experts in aesthetics to establish a strong scientific presence in the clinical and academic communities. Collaborate with the MSL teams to ensure external expert development and communication is optimized. Collaborate with Health Economic and Outcomes Research (HEOR) team to establish scientific and clinical credibility for clinical outcomes focused on patient reported outcomes. Assess support of external IIS proposals and concepts related to Body Contouring to ensure alignment with IIS priorities. Deliver portfolio-related clinical presentations as needed and participate in prioritized scientific congresses. Collect HCP and MSL insights to inform Allergan Aesthetics / AbbVie strategy (e.g. via advisory boards, strategic insights, field insight discussions).
Job Description Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. Responsibilities: Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs. May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs). Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes to partnership with Discovery colleagues to design and implementation of translational strategies. Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
03/27/2024
Full time
Job Description Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. Responsibilities: Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff. Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs. May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs). Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes to partnership with Discovery colleagues to design and implementation of translational strategies. Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Job Description Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. May oversee the work of Associate Scientific Directors and/or of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on an Integrated Evidence Strategy Team (IEST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
03/25/2024
Full time
Job Description Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and AbbVie study staff. Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents. May oversee the work of Associate Scientific Directors and/or of Clinical Scientists working on the same or related programs. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. May serve on an Integrated Evidence Strategy Team (IEST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Job Description Reporting to the Director, Global Brand Team Lead, Oncology, this position supports the development and execution of the marketing strategies and tactics at the Global, Areas, and Country-Affiliate level. The candidate will collaborate and engage with a matrixed team, which includes (but not limited to): market access, medical affairs, finance, regulatory, legal, supply operations, health economics, clinical development, R&D, public affairs, medical and regulatory review, patient relations, business insights, OEC, and sales training. This role requires a highly motivated, team-oriented individual who seeks to make a remarkable impact for patients with oncology, the most complex treatment landscape in oncology. This is a great opportunity to: strengthen Global launch experience in a competitive market; introduce the first biomarker therapy. Contribute further growth to an existing multi-blockbuster brand; and collaborate with a stellar team! Key Responsibilities Include: • Prepare for exceptional Global brand launch that includes a Companion Diagnostic in highly competitive therapeutic area. • Collaborate and lead by example with cross functional and cross geographic teams to generate effective brand strategies and tactical plans to deliver business results. • Identify, analyze and translate product, brand, customer, patient, and relevant information to frame and solve business problems and build effective marketing plans. • Effectively direct research team efforts in primary research projects and understand the healthcare business environment including familiarity with global markets and payers, distribution channels, and pricing strategies. • Develop and articulate effective marketing strategies and tactics that provide impact, are executable, easily communicated, and clinically/financially supported for areas of responsibility (product/indication/channel). • Demonstrate ability to segment a market, select optimal target audiences and position effectively for the target segment. • Continually evaluate and apply knowledge of the effectiveness (share impact/ROI) and efficiency (expense control) of promotional tactics. • Effectively lead projects to deliver high-quality work product in a timely fashion to meet deadlines and commitments. • Ensure that regulatory and compliance guidelines are followed. • All these responsibilities will strongly contribute to a successful worldwide Launch. Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
03/19/2024
Full time
Job Description Reporting to the Director, Global Brand Team Lead, Oncology, this position supports the development and execution of the marketing strategies and tactics at the Global, Areas, and Country-Affiliate level. The candidate will collaborate and engage with a matrixed team, which includes (but not limited to): market access, medical affairs, finance, regulatory, legal, supply operations, health economics, clinical development, R&D, public affairs, medical and regulatory review, patient relations, business insights, OEC, and sales training. This role requires a highly motivated, team-oriented individual who seeks to make a remarkable impact for patients with oncology, the most complex treatment landscape in oncology. This is a great opportunity to: strengthen Global launch experience in a competitive market; introduce the first biomarker therapy. Contribute further growth to an existing multi-blockbuster brand; and collaborate with a stellar team! Key Responsibilities Include: • Prepare for exceptional Global brand launch that includes a Companion Diagnostic in highly competitive therapeutic area. • Collaborate and lead by example with cross functional and cross geographic teams to generate effective brand strategies and tactical plans to deliver business results. • Identify, analyze and translate product, brand, customer, patient, and relevant information to frame and solve business problems and build effective marketing plans. • Effectively direct research team efforts in primary research projects and understand the healthcare business environment including familiarity with global markets and payers, distribution channels, and pricing strategies. • Develop and articulate effective marketing strategies and tactics that provide impact, are executable, easily communicated, and clinically/financially supported for areas of responsibility (product/indication/channel). • Demonstrate ability to segment a market, select optimal target audiences and position effectively for the target segment. • Continually evaluate and apply knowledge of the effectiveness (share impact/ROI) and efficiency (expense control) of promotional tactics. • Effectively lead projects to deliver high-quality work product in a timely fashion to meet deadlines and commitments. • Ensure that regulatory and compliance guidelines are followed. • All these responsibilities will strongly contribute to a successful worldwide Launch. Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Guilford Technical Community College
Jamestown, North Carolina
#RPM Teaching faculty at Guilford Technical Community College are responsible for supporting student success by creating an optimum learning environment, responding to student needs, managing effective instructional activities, developing Emergency Medical Science (EMS) courses, modeling employability skills, demonstrating professionalism, developing cooperative work relationships with other faculty and staff, supporting college administrative requirements, and maintaining competency in their instructional field. He/she will be responsible for quality instruction and for effective participation and interest in the total affairs of the college. The EMS OE Instructor will prepare and teach the non-credit In-Service Training, pre-service EMT training as well as American Heart Association courses and the training in accordance with the requirements of the North Carolina Office of Emergency Medical Science (NCOEMS). This position will support program functions by providing customer service, data support and documentation services. It will also work to maintain program compliance with accreditation standards according to Guilford Technical Community College (GTCC), American Heart Association (AHA), Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions (CoAEMSP), Commission on Accreditation of Allied Health Education Programs (CAHEEP) and Commission on Accreditation for Pre-Hospital Continuing Education (CAPSE). This position reports directly to the Program Director of EMS, with oversight by the Dean of Human Services and Public Safety. Duties/Functions Teaching Prepare & teach departmental courses to include: developing learner centered lesson plans employing teaching strategies & instructional materials for different learning styles incorporating, as pedagogically appropriate, current technology in classroom, distance learning and laboratory environments creating and modeling a quality learning environment that supports a diverse student population preparing, distributing and utilizing instructional support materials, including course syllabi, supplementary materials, instructional media and other devices as appropriate updating and revising curriculum to maintain currency developing new courses as needed to support the instructional mission participating in the development and review of course and program/general education outcomes as appropriate developing, conducting and documenting appropriate assessment of student learning in outcomes courses and programs/general education as appropriate Professional Development Maintain a professional status that supports the instructional mission by: participating in professional development activities to maintain currency in field; maintaining current credentials or licensures as required by program or accreditation participating in professional development opportunities to advance teaching skills and strategies Administration Provide daily & ongoing oversight of facilities, equipment and student records to include: maintaining classroom and laboratory spaces including upkeep of assigned equipment providing for the security of facilities, equipment and instructional materials and maintaining safe working conditions maintaining student records (e.g., grades and attendance) in accordance with established deadlines using a variety of technology-based programs (e.g., Colleague, WebAdvisor, Moodle) complying with all applicable college, state and federal rules and regulations Student Support Provide an environment conducive to student success to include: conducting recruiting activities providing academic advising promoting retention/persistence by assisting students to develop strategies for success assisting students with the registration and graduation process referring students to campus and community resources when appropriate maintain student records College Service Support college-wide endeavors to include: collaboration with faculty and staff from other divisions/departments to promote communication, coordinate schedules and support student success serving on department, division and college committees participating in GTCC institutional initiatives collaborating with educational partners, business/industry and/or external agencies as appropriate to promote the instructional mission of GTCC supporting collegiality and teaching excellence by actively participating in the professional development of new and veteran faculty (e.g., mentoring and peer observation) participating in extracurricular student activities/clubs attending college professional development sessions, college/division/department meetings, graduation and convocation, as required demonstrate and model the Colleges employability skills: adaptability, communication, information processing, problem solving, responsibility and teamwork. perform all duties as assigned by supervisor Difficult Challenges Contacts Education Required Associates degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution North Carolina Paramedic Credential North Carolina Level I Emergency Medical Technician (EMT) Instructor Certification or the ability to obtain it within one year of hire. Valid North Carolina Drivers License Education Preferred Bachelors degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution American Heart Association Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS) and/ or Pediatric Advanced Life Support (PALS) Instructor Certification North Carolina Level I Paramedic Instructor Certification Experience Required Three years of relevant or closely related field experience in Emergency Medical Science (EMS) One year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Experience Preferred Greater than three years of relevant field experience in Emergency Medical Science (EMS) or closely related career field Greater than one year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Post-secondary teaching experience Experience with assessment of student learning outcomes KSA Required The Instructor shall possess an understanding of and commitment to the nature and role of the Community College, particularly its open door policy. He/she shall have demonstrated personal and professional competence for the responsibilities assigned. The Instructor must be able to: 1. Multi-task 2. Respect Diversity 3. Adapt to changing procedures, protocols or assignments. 4. Create and maintain a learner centered environment 5. Communicate effectively 6. Ability to effectively implement and apply technology solutions KSA Preferred Department/Job Specific Requirements Physical Requirements Hear and see Stand extended periods of time (up to 4 hours) Lift up to 50 pounds unassisted. Stoop, bend, squat, lift, reach overhead Use and manipulate EMS equipment according to industry standards Participate in and demonstrate physical aspects of EMS work and physical training The following (compliance) training is required and must be completed within the first 30 days of hire with annual refresher training thereafter: (additional training may be added as needed) Reporting Requirements Anti-Discrimination/Harassment & Title IX Safety/Shooter on Campus Personal Information Protection Training (PIP) Ethics and Social Responsibility eLearning Level One (before the first day of the first semester teaching) eLearning Levels Two and Three for instructors who teach online or hybrid delivery methods (before the first day of the first semester teaching) Physical Demands Physical Activity:Long periods of standing and or walking Environmental Hazard(s):30-70% Lifting:=>50lbs. Criminal history checks with acceptable results, are required. Posting Type Faculty recblid wlec6xqxkvpoxrp5yduinyt3ga15sc
02/27/2022
Full time
#RPM Teaching faculty at Guilford Technical Community College are responsible for supporting student success by creating an optimum learning environment, responding to student needs, managing effective instructional activities, developing Emergency Medical Science (EMS) courses, modeling employability skills, demonstrating professionalism, developing cooperative work relationships with other faculty and staff, supporting college administrative requirements, and maintaining competency in their instructional field. He/she will be responsible for quality instruction and for effective participation and interest in the total affairs of the college. The EMS OE Instructor will prepare and teach the non-credit In-Service Training, pre-service EMT training as well as American Heart Association courses and the training in accordance with the requirements of the North Carolina Office of Emergency Medical Science (NCOEMS). This position will support program functions by providing customer service, data support and documentation services. It will also work to maintain program compliance with accreditation standards according to Guilford Technical Community College (GTCC), American Heart Association (AHA), Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions (CoAEMSP), Commission on Accreditation of Allied Health Education Programs (CAHEEP) and Commission on Accreditation for Pre-Hospital Continuing Education (CAPSE). This position reports directly to the Program Director of EMS, with oversight by the Dean of Human Services and Public Safety. Duties/Functions Teaching Prepare & teach departmental courses to include: developing learner centered lesson plans employing teaching strategies & instructional materials for different learning styles incorporating, as pedagogically appropriate, current technology in classroom, distance learning and laboratory environments creating and modeling a quality learning environment that supports a diverse student population preparing, distributing and utilizing instructional support materials, including course syllabi, supplementary materials, instructional media and other devices as appropriate updating and revising curriculum to maintain currency developing new courses as needed to support the instructional mission participating in the development and review of course and program/general education outcomes as appropriate developing, conducting and documenting appropriate assessment of student learning in outcomes courses and programs/general education as appropriate Professional Development Maintain a professional status that supports the instructional mission by: participating in professional development activities to maintain currency in field; maintaining current credentials or licensures as required by program or accreditation participating in professional development opportunities to advance teaching skills and strategies Administration Provide daily & ongoing oversight of facilities, equipment and student records to include: maintaining classroom and laboratory spaces including upkeep of assigned equipment providing for the security of facilities, equipment and instructional materials and maintaining safe working conditions maintaining student records (e.g., grades and attendance) in accordance with established deadlines using a variety of technology-based programs (e.g., Colleague, WebAdvisor, Moodle) complying with all applicable college, state and federal rules and regulations Student Support Provide an environment conducive to student success to include: conducting recruiting activities providing academic advising promoting retention/persistence by assisting students to develop strategies for success assisting students with the registration and graduation process referring students to campus and community resources when appropriate maintain student records College Service Support college-wide endeavors to include: collaboration with faculty and staff from other divisions/departments to promote communication, coordinate schedules and support student success serving on department, division and college committees participating in GTCC institutional initiatives collaborating with educational partners, business/industry and/or external agencies as appropriate to promote the instructional mission of GTCC supporting collegiality and teaching excellence by actively participating in the professional development of new and veteran faculty (e.g., mentoring and peer observation) participating in extracurricular student activities/clubs attending college professional development sessions, college/division/department meetings, graduation and convocation, as required demonstrate and model the Colleges employability skills: adaptability, communication, information processing, problem solving, responsibility and teamwork. perform all duties as assigned by supervisor Difficult Challenges Contacts Education Required Associates degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution North Carolina Paramedic Credential North Carolina Level I Emergency Medical Technician (EMT) Instructor Certification or the ability to obtain it within one year of hire. Valid North Carolina Drivers License Education Preferred Bachelors degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution American Heart Association Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS) and/ or Pediatric Advanced Life Support (PALS) Instructor Certification North Carolina Level I Paramedic Instructor Certification Experience Required Three years of relevant or closely related field experience in Emergency Medical Science (EMS) One year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Experience Preferred Greater than three years of relevant field experience in Emergency Medical Science (EMS) or closely related career field Greater than one year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Post-secondary teaching experience Experience with assessment of student learning outcomes KSA Required The Instructor shall possess an understanding of and commitment to the nature and role of the Community College, particularly its open door policy. He/she shall have demonstrated personal and professional competence for the responsibilities assigned. The Instructor must be able to: 1. Multi-task 2. Respect Diversity 3. Adapt to changing procedures, protocols or assignments. 4. Create and maintain a learner centered environment 5. Communicate effectively 6. Ability to effectively implement and apply technology solutions KSA Preferred Department/Job Specific Requirements Physical Requirements Hear and see Stand extended periods of time (up to 4 hours) Lift up to 50 pounds unassisted. Stoop, bend, squat, lift, reach overhead Use and manipulate EMS equipment according to industry standards Participate in and demonstrate physical aspects of EMS work and physical training The following (compliance) training is required and must be completed within the first 30 days of hire with annual refresher training thereafter: (additional training may be added as needed) Reporting Requirements Anti-Discrimination/Harassment & Title IX Safety/Shooter on Campus Personal Information Protection Training (PIP) Ethics and Social Responsibility eLearning Level One (before the first day of the first semester teaching) eLearning Levels Two and Three for instructors who teach online or hybrid delivery methods (before the first day of the first semester teaching) Physical Demands Physical Activity:Long periods of standing and or walking Environmental Hazard(s):30-70% Lifting:=>50lbs. Criminal history checks with acceptable results, are required. Posting Type Faculty recblid wlec6xqxkvpoxrp5yduinyt3ga15sc
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
09/26/2021
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
09/25/2021
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
Job Summary Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements. The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications. Key Responsibilities: Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ), Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints). Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments Drives insights generation through ongoing, active monitoring Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR) Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance Provides input into changes or improvements to the Quality Management System (QMS) Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections Ensures a pool of subject matter experts are prepared to support audit and inspection activities Maintains responsibility as document custodian (e.g., playbooks etc.) Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities Provides compliance-based recommendations and coordinates mitigation activities Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.) Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments) Supports and identifies continual improvement initiatives, programs and projects Leads cross-functional initiatives Ensures execution of regulatory and SOP requirements Provides guidance and technical advice Basic Qualifications Doctorate degree and 4 years of Quality experience OR Masters degree and 8 years of Quality experience OR Bachelors degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Knowledge of current Global regulations for final drug product, combination product, and devices and their application In depth understanding of Investigations and Root Cause Analysis Understands criticality of connectivity between product complaints and adverse events Significant experience hosting or participating in regulatory inspections Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes Ability to work in a team matrix environment and independently interact with various levels of management Excellent communication skills, both written and oral Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Proven ability to create cross-functional networks/partnerships Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally Able to successfully manage workload, timelines, and priorities Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Ability to negotiate a strategic position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving effective decision making Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Ability to travel +/- 20% of time to domestic and international Amgen sites Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
09/14/2021
Full time
Job Summary Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements. The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications. Key Responsibilities: Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ), Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints). Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments Drives insights generation through ongoing, active monitoring Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR) Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance Provides input into changes or improvements to the Quality Management System (QMS) Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections Ensures a pool of subject matter experts are prepared to support audit and inspection activities Maintains responsibility as document custodian (e.g., playbooks etc.) Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities Provides compliance-based recommendations and coordinates mitigation activities Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.) Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments) Supports and identifies continual improvement initiatives, programs and projects Leads cross-functional initiatives Ensures execution of regulatory and SOP requirements Provides guidance and technical advice Basic Qualifications Doctorate degree and 4 years of Quality experience OR Masters degree and 8 years of Quality experience OR Bachelors degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Knowledge of current Global regulations for final drug product, combination product, and devices and their application In depth understanding of Investigations and Root Cause Analysis Understands criticality of connectivity between product complaints and adverse events Significant experience hosting or participating in regulatory inspections Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes Ability to work in a team matrix environment and independently interact with various levels of management Excellent communication skills, both written and oral Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Proven ability to create cross-functional networks/partnerships Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally Able to successfully manage workload, timelines, and priorities Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Ability to negotiate a strategic position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving effective decision making Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Ability to travel +/- 20% of time to domestic and international Amgen sites Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
NC State Agency needs attorney to serve as Associate Legal Counsel I to prosecute cases before the Commission involving character qualifications of applicants. License to practice law in the State of NC and responsible professional experience required. $72,324 - $86,788 (based on experience and qualifications), plus excellent benefits. Must reside in Raleigh area. Distinguishing Features of the Class An employee in this class performs legal services for areas of law that are limited in scope and complexity in comparison with the Senior Attorney level, may assist higher level attorneys with cases, serves as legal counsel for the Commission on simple disciplinary and character application cases, conducts settlement negotiations and oversees case management. Work involves providing advice to non-attorney complaint and information staff on cases, writing informational materials on legal matters, and overseeing the work of the Administrative Procedures Act coordinator to assure a thorough and timely rulemaking process. Employee prepares legal documents and presents cases to the Commission. Employee conducts legal research in the law relating to licensing and professional discipline, and keeps informed of Commission policies and actions. Independent professional judgment, initiative and public contact skills are essential in performing various duties. Work requires considerable knowledge of State real estate laws and Commission policies and rules, as well as strong analytical skills. Work is performed under the general supervision of the Director, Assistant Director of Regulatory Affairs, and Deputy Legal Counsel and is reviewed through discussion, results achieved, and feedback from the Commission, licensees and the public. Application deadline September 13. NC Real Estate Commission. EOE. recblid gmlqowprb6wx0jwyfq8fcb5iw9g3dp
09/13/2021
Full time
NC State Agency needs attorney to serve as Associate Legal Counsel I to prosecute cases before the Commission involving character qualifications of applicants. License to practice law in the State of NC and responsible professional experience required. $72,324 - $86,788 (based on experience and qualifications), plus excellent benefits. Must reside in Raleigh area. Distinguishing Features of the Class An employee in this class performs legal services for areas of law that are limited in scope and complexity in comparison with the Senior Attorney level, may assist higher level attorneys with cases, serves as legal counsel for the Commission on simple disciplinary and character application cases, conducts settlement negotiations and oversees case management. Work involves providing advice to non-attorney complaint and information staff on cases, writing informational materials on legal matters, and overseeing the work of the Administrative Procedures Act coordinator to assure a thorough and timely rulemaking process. Employee prepares legal documents and presents cases to the Commission. Employee conducts legal research in the law relating to licensing and professional discipline, and keeps informed of Commission policies and actions. Independent professional judgment, initiative and public contact skills are essential in performing various duties. Work requires considerable knowledge of State real estate laws and Commission policies and rules, as well as strong analytical skills. Work is performed under the general supervision of the Director, Assistant Director of Regulatory Affairs, and Deputy Legal Counsel and is reviewed through discussion, results achieved, and feedback from the Commission, licensees and the public. Application deadline September 13. NC Real Estate Commission. EOE. recblid gmlqowprb6wx0jwyfq8fcb5iw9g3dp
Allogene Therapeutics
South San Francisco, California
About Allogene Therapeutics, Inc:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit , and on Twitter and LinkedIn.Job Description:Allogene is looking for a seasoned, broadly trained scientist and manager to oversee the external quality Control (QC) testing laboratory operations supporting the CAR T products clinical and commercial manufacturing. Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The candidate will support the QC organization in ensuring the readiness of QC contract testing laboratories (CTL) for the seamless execution of release and stability testing within agreed upon timeline to meet clinical demands according to plan and budget. The candidate will support the QC head and partner with External Quality Assurance (QA), as well as external partners in defining laboratory systems and processes for the compliant operation of this external QC laboratory network, defining and tracking key performance indicators, and resolving issues as they arise. The candidate will maintain strong connections with the internal Allogene QC laboratories ensuring alignment on requirements for methods, critical reagents, and instruments as needed. The role will entail operating in a fast-paced, highly dynamic environment with company work partnerships including both internal and external stakeholders. This role will report to the Head of QC.Responsibilities include, but are not limited to: Provides leadership, management and technical oversight for the successful execution of release and stability testing at various CTL within agreed upon turnaround-time (TAT) and within budget. Responsible for the review of CTL data, ensuring that they are maintained in compliance with regulatory and Allogenes requirements. Coordinates with Allogene laboratory heads and CTL the maintenance and management of critical laboratory reagents, standards and controls ensuring uninterrupted operation. Establishes processes to trend methods performance at CTL over time. Align with internal Allogene laboratories on control materials and performance as needed. Ensures, where applicable, alignment on instrument requirements/equivalency between Allogene and CTL. Keeps current with revisions to test methods at Allogene and CTL. Where applicable, revises methods and related documentation per established change management procedures at Allogene and CTL. Aligns and coordinates with stability manager on stability samples testing to ensure timely execution and adherence to stability studies schedules. Manages performance of CTL by tracking and ensuring established KPI are met. Escalates CTL performance issues to management in a timely manner. Actively manage CTL associated costs and ensure compliance with budget goals. Oversees validation/verification of methods for CAR T products and raw materials at CTL ensuring compliance with regulatory requirements. Provides direction and guidance to authors of method validations/verifications protocols and reports and evaluate data generated from these activities. Investigates and oversees validation exception reports where needed. In collaboration with Allogene laboratory heads and Head of Infrastructure Support and Methods Life Cycle, oversees technical transfer of CAR T and raw materials methods to and from CTL in line with regulatory requirements and per project timeline and budget. Establishes new and improves existing processes for transfer ensuring cross functional alignment with stakeholders across sites Provides technical guidance and management support for testing related nonconformance events, associated corrective and preventative actions and change control. Collaborates effectively with Allogene External QA to manage the initiation, evaluation, and closure of nonconformance events and CAPA implementation plans at CTL. Investigates unexpected/Out of Specification/Out of Trend test results. Helps define investigation/re-test plans, where applicable. Collaborates effectively with Allogenes and the CTLs QA representatives to manage the initiation, investigation, and compliant closure of these events. Authors and reviews technical registration documents and other sections of regulatory submissions pertaining to methods executed at CTL. Supports Allogene inspections and audits at CTL sites as well as internal Allogene regulatory inspections as the CTL liaison. Supports external QA in ensuring CTL are ready for GMP and pre-approval inspections (PAI). Collaborates cross functionally and builds relationships with external CTL and within Allogene QC, QA, Regulatory Affairs, Development, Manufacturing and Supply Chain to meet target milestones. Be able to negotiate, influence, and work in a matrix environment and across sites. Manages multiple projects, set priorities, and work in a fast-paced environment. Able to negotiate, influence, and work in a matrix environment. Other duties as assignedPosition Requirements & Experience: M.S./B.S. Degree, Ph.D. is a plus. Minimum 6-8 years of analytical development/QC laboratory experience in biotechnology with 2-4 years in a management role. Experience with analytical and biochemical methods including but not limited to cell-based assays/techniques including FACS analysis, potency testing, and immunofluorescence, molecular biology methodologies including but not limited to DNA, RNA manipulation and PCR, ELISA/HTRF, as well as electrophoresis/western blot analysis. Experience with HPLC systems is a plus. Experience with microbiological tests including compendial sterility testing, mycoplasma, endotoxin and viral testing. Strong understanding of GMP requirements and QC systems Experience with method development, validation and transfer Experience in dealing with regulatory agencies, supporting GMP and PAI inspections as well as experience with regulatory filings. Strong leadership ability, interpersonal, communication, and influencing skills required. Highly collaborative with the proven ability to work in a cross-functional team. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Expected to travel 15-20% of time. Candidates must be authorized to work in the U.S. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonablyAs an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.#LI-EL1
08/31/2021
Full time
About Allogene Therapeutics, Inc:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit , and on Twitter and LinkedIn.Job Description:Allogene is looking for a seasoned, broadly trained scientist and manager to oversee the external quality Control (QC) testing laboratory operations supporting the CAR T products clinical and commercial manufacturing. Allogene plans to create an outstanding product design, characterization and qualification capability in the allogeneic cell therapy space. The candidate will support the QC organization in ensuring the readiness of QC contract testing laboratories (CTL) for the seamless execution of release and stability testing within agreed upon timeline to meet clinical demands according to plan and budget. The candidate will support the QC head and partner with External Quality Assurance (QA), as well as external partners in defining laboratory systems and processes for the compliant operation of this external QC laboratory network, defining and tracking key performance indicators, and resolving issues as they arise. The candidate will maintain strong connections with the internal Allogene QC laboratories ensuring alignment on requirements for methods, critical reagents, and instruments as needed. The role will entail operating in a fast-paced, highly dynamic environment with company work partnerships including both internal and external stakeholders. This role will report to the Head of QC.Responsibilities include, but are not limited to: Provides leadership, management and technical oversight for the successful execution of release and stability testing at various CTL within agreed upon turnaround-time (TAT) and within budget. Responsible for the review of CTL data, ensuring that they are maintained in compliance with regulatory and Allogenes requirements. Coordinates with Allogene laboratory heads and CTL the maintenance and management of critical laboratory reagents, standards and controls ensuring uninterrupted operation. Establishes processes to trend methods performance at CTL over time. Align with internal Allogene laboratories on control materials and performance as needed. Ensures, where applicable, alignment on instrument requirements/equivalency between Allogene and CTL. Keeps current with revisions to test methods at Allogene and CTL. Where applicable, revises methods and related documentation per established change management procedures at Allogene and CTL. Aligns and coordinates with stability manager on stability samples testing to ensure timely execution and adherence to stability studies schedules. Manages performance of CTL by tracking and ensuring established KPI are met. Escalates CTL performance issues to management in a timely manner. Actively manage CTL associated costs and ensure compliance with budget goals. Oversees validation/verification of methods for CAR T products and raw materials at CTL ensuring compliance with regulatory requirements. Provides direction and guidance to authors of method validations/verifications protocols and reports and evaluate data generated from these activities. Investigates and oversees validation exception reports where needed. In collaboration with Allogene laboratory heads and Head of Infrastructure Support and Methods Life Cycle, oversees technical transfer of CAR T and raw materials methods to and from CTL in line with regulatory requirements and per project timeline and budget. Establishes new and improves existing processes for transfer ensuring cross functional alignment with stakeholders across sites Provides technical guidance and management support for testing related nonconformance events, associated corrective and preventative actions and change control. Collaborates effectively with Allogene External QA to manage the initiation, evaluation, and closure of nonconformance events and CAPA implementation plans at CTL. Investigates unexpected/Out of Specification/Out of Trend test results. Helps define investigation/re-test plans, where applicable. Collaborates effectively with Allogenes and the CTLs QA representatives to manage the initiation, investigation, and compliant closure of these events. Authors and reviews technical registration documents and other sections of regulatory submissions pertaining to methods executed at CTL. Supports Allogene inspections and audits at CTL sites as well as internal Allogene regulatory inspections as the CTL liaison. Supports external QA in ensuring CTL are ready for GMP and pre-approval inspections (PAI). Collaborates cross functionally and builds relationships with external CTL and within Allogene QC, QA, Regulatory Affairs, Development, Manufacturing and Supply Chain to meet target milestones. Be able to negotiate, influence, and work in a matrix environment and across sites. Manages multiple projects, set priorities, and work in a fast-paced environment. Able to negotiate, influence, and work in a matrix environment. Other duties as assignedPosition Requirements & Experience: M.S./B.S. Degree, Ph.D. is a plus. Minimum 6-8 years of analytical development/QC laboratory experience in biotechnology with 2-4 years in a management role. Experience with analytical and biochemical methods including but not limited to cell-based assays/techniques including FACS analysis, potency testing, and immunofluorescence, molecular biology methodologies including but not limited to DNA, RNA manipulation and PCR, ELISA/HTRF, as well as electrophoresis/western blot analysis. Experience with HPLC systems is a plus. Experience with microbiological tests including compendial sterility testing, mycoplasma, endotoxin and viral testing. Strong understanding of GMP requirements and QC systems Experience with method development, validation and transfer Experience in dealing with regulatory agencies, supporting GMP and PAI inspections as well as experience with regulatory filings. Strong leadership ability, interpersonal, communication, and influencing skills required. Highly collaborative with the proven ability to work in a cross-functional team. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Ability to work independently and as part of a team. Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment. Expected to travel 15-20% of time. Candidates must be authorized to work in the U.S. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonablyAs an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.#LI-EL1
About Lumen Lumen is guided by our belief that humanity is at its best when technology advances the way we live and work. With 450,000 route fiber miles serving customers in more than 60 countries, we deliver the fastest, most secure global platform for applications and data to help businesses, government and communities deliver amazing experiences. Learn more about Lumen's network, edge cloud, security and communication and collaboration solutions and our purpose to further human progress through technology at news.lumen.com, LinkedIn: /lumentechnologies, Facebook: /lumentechnologies, and YouTube: /lumentechnologies. The Role The Senior Corporate Counsel reports to an Associate General Counsel - Government Affairs and Public Policy in the company's State Government Affairs organization, serving as Lumen's attorney in matters before various state public utility commissions. This position works closely with Lumen's Government Affairs Directors in multiple states, as well as with policy experts and other regulatory and legislative analysts to support the company's regulatory, legislative, and business objectives. NOTE: Position could be located in Denver, Colorado, Salt Lake City, or possibly a remote location. The Main Responsibilities Represent the company before state public utility commissions in both contested case matters and in rulemaking projects, and as an advocate in other matters; from time to time represent the company before other state administrative agencies and local authorities Act as lead attorney in litigation before state public utility commissions involving complex technical, economic, legal, and policy issues, including (but not limited to) drafting of pleadings, motions, and legal briefs, presenting witnesses and conducting cross examination, and managing litigation-related tasks such as development of discovery requests, production of discovery responses, and development of witness testimony Provide expert legal advice on complex matters regarding telecommunications regulation, including drafting of legal and regulatory analyses and risk assessments Provide ongoing legal support to business units and the internal government affairs team to ensure compliance with both new and existing utility laws and regulations, and proactively monitor regulatory and legal developments that may impact the business of the company Engage with and negotiate with other parties, such as litigants, complainants, business competitors, property owners and managers, other utilities such as railroads, and state and local authorities Draft and edit letters, notices, policy statements, tariff provisions, rulemaking comments, and proposed legislation; may occasionally be required to interpret contracts and other commercial instruments and may draft or edit such documents Work closely with other internal regulatory affairs, legislative affairs, and policy experts to develop proactive strategies for achieving the business objectives of the company What We Look For in a Candidate 6-10 years of relevant legal experience, preferably with experience in state or federal administrative law or litigation related to the regulation and business of telecommunications and information services Excellent writing and oral communication skills Experience drafting relevant documents, particularly legal briefs, rulemaking comments and proposed legislation - including general familiarity with document development via Word and Excel. In-depth knowledge or demonstrated ability to gain knowledge of complex technical and economic concepts related to a network-related industry, preferably involving telecommunications and/or information technology Demonstrated leadership and teamwork skills achieving stated objectives while managing varied projects and a sometimes-heavy workload Demonstrated client relationship skills to continuously coordinate with internal business units and other internal legal groups Demonstrated self-starter requiring minimal supervision with the ability to gain required knowledge of new business and legal developments Experience in a technology-oriented business is highly preferred, experience in a telecommunications business is a plus. Must be a team player. Sound legal and business judgment. Juris Doctor from accredited law school. What to Expect Next Requisition #: 246113 EEO Statement We are committed to providing equal employment opportunities to all persons regardless of race, color, ancestry, citizenship, national origin, religion, veteran status, disability, genetic characteristic or information, age, gender, sexual orientation, gender identity, marital status, family status, pregnancy, or other legally protected status (collectively, "protected statuses"). We do not tolerate unlawful discrimination in any employment decisions, including recruiting, hiring, compensation, promotion, benefits, discipline, termination, job assignments or training. Disclaimer The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions.
03/16/2021
Full time
About Lumen Lumen is guided by our belief that humanity is at its best when technology advances the way we live and work. With 450,000 route fiber miles serving customers in more than 60 countries, we deliver the fastest, most secure global platform for applications and data to help businesses, government and communities deliver amazing experiences. Learn more about Lumen's network, edge cloud, security and communication and collaboration solutions and our purpose to further human progress through technology at news.lumen.com, LinkedIn: /lumentechnologies, Facebook: /lumentechnologies, and YouTube: /lumentechnologies. The Role The Senior Corporate Counsel reports to an Associate General Counsel - Government Affairs and Public Policy in the company's State Government Affairs organization, serving as Lumen's attorney in matters before various state public utility commissions. This position works closely with Lumen's Government Affairs Directors in multiple states, as well as with policy experts and other regulatory and legislative analysts to support the company's regulatory, legislative, and business objectives. NOTE: Position could be located in Denver, Colorado, Salt Lake City, or possibly a remote location. The Main Responsibilities Represent the company before state public utility commissions in both contested case matters and in rulemaking projects, and as an advocate in other matters; from time to time represent the company before other state administrative agencies and local authorities Act as lead attorney in litigation before state public utility commissions involving complex technical, economic, legal, and policy issues, including (but not limited to) drafting of pleadings, motions, and legal briefs, presenting witnesses and conducting cross examination, and managing litigation-related tasks such as development of discovery requests, production of discovery responses, and development of witness testimony Provide expert legal advice on complex matters regarding telecommunications regulation, including drafting of legal and regulatory analyses and risk assessments Provide ongoing legal support to business units and the internal government affairs team to ensure compliance with both new and existing utility laws and regulations, and proactively monitor regulatory and legal developments that may impact the business of the company Engage with and negotiate with other parties, such as litigants, complainants, business competitors, property owners and managers, other utilities such as railroads, and state and local authorities Draft and edit letters, notices, policy statements, tariff provisions, rulemaking comments, and proposed legislation; may occasionally be required to interpret contracts and other commercial instruments and may draft or edit such documents Work closely with other internal regulatory affairs, legislative affairs, and policy experts to develop proactive strategies for achieving the business objectives of the company What We Look For in a Candidate 6-10 years of relevant legal experience, preferably with experience in state or federal administrative law or litigation related to the regulation and business of telecommunications and information services Excellent writing and oral communication skills Experience drafting relevant documents, particularly legal briefs, rulemaking comments and proposed legislation - including general familiarity with document development via Word and Excel. In-depth knowledge or demonstrated ability to gain knowledge of complex technical and economic concepts related to a network-related industry, preferably involving telecommunications and/or information technology Demonstrated leadership and teamwork skills achieving stated objectives while managing varied projects and a sometimes-heavy workload Demonstrated client relationship skills to continuously coordinate with internal business units and other internal legal groups Demonstrated self-starter requiring minimal supervision with the ability to gain required knowledge of new business and legal developments Experience in a technology-oriented business is highly preferred, experience in a telecommunications business is a plus. Must be a team player. Sound legal and business judgment. Juris Doctor from accredited law school. What to Expect Next Requisition #: 246113 EEO Statement We are committed to providing equal employment opportunities to all persons regardless of race, color, ancestry, citizenship, national origin, religion, veteran status, disability, genetic characteristic or information, age, gender, sexual orientation, gender identity, marital status, family status, pregnancy, or other legally protected status (collectively, "protected statuses"). We do not tolerate unlawful discrimination in any employment decisions, including recruiting, hiring, compensation, promotion, benefits, discipline, termination, job assignments or training. Disclaimer The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions.
Regeneron Pharmaceuticals, Inc.
Tarrytown, New York
The position with the Regulatory and Commercial Law team will provide proactive and collaborative legal support in connection one or more of Regeneron's products and will act as a legal advisor to our sales, marketing, medical affairs, regulatory, and compliance teams. The role will counsel our internal partners through a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to the discovery, development, sales and marketing of biotechnology products (including healthcare fraud and abuse laws). The ideal candidate will have relevant in-house experience counseling on an approved product and providing practical and strategic legal advice on a broad range of issues. As an Associate Director, Corporate Counsel, a typical day may include: Providing product support counseling for one or more of Regeneron's products/product candidates from development through commercialization and lifecycle planning Overseeing the review and approval of external funding requests, including educational grants, sponsorships, collaborations, and charitable donations. Serving as a voting legal member on relevant external funding committees and proactively helping to develop and improve vital policies and procedures. Reviewing and approving of needs assessments of proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements. Providing legal support for our patient assistance programs and market access contracts. Assisting with a broad range of healthcare regulatory matters including monitoring the enforcement environment, client training, and compliance policy development. This role might be for you if you: Have outstanding interpersonal and conflict resolution skills Work well independently, while meeting aggressive deadlines and prioritizing multiple matters Collaborate closely with internal clients (including scientific and business leaders) with strategic transactions Have exceptional oral and written communication skills Maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations and protecting Regeneron's interests Work effectively and expertly with colleagues & clients in a collaborative environment Collaborate and advise key stakeholders, including senior management, on contracts group policies and procedures To be considered for this position, you must possess: A solid understanding of commercialization, contracts and related law within the biotech/pharmaceutical industry. JD with excellent law school credentials; licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. At least 5 to 10 years of legal experience at a law firm and/or in-house, including biotech/pharmaceutical and/or health care experience. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
03/04/2021
Full time
The position with the Regulatory and Commercial Law team will provide proactive and collaborative legal support in connection one or more of Regeneron's products and will act as a legal advisor to our sales, marketing, medical affairs, regulatory, and compliance teams. The role will counsel our internal partners through a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to the discovery, development, sales and marketing of biotechnology products (including healthcare fraud and abuse laws). The ideal candidate will have relevant in-house experience counseling on an approved product and providing practical and strategic legal advice on a broad range of issues. As an Associate Director, Corporate Counsel, a typical day may include: Providing product support counseling for one or more of Regeneron's products/product candidates from development through commercialization and lifecycle planning Overseeing the review and approval of external funding requests, including educational grants, sponsorships, collaborations, and charitable donations. Serving as a voting legal member on relevant external funding committees and proactively helping to develop and improve vital policies and procedures. Reviewing and approving of needs assessments of proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements. Providing legal support for our patient assistance programs and market access contracts. Assisting with a broad range of healthcare regulatory matters including monitoring the enforcement environment, client training, and compliance policy development. This role might be for you if you: Have outstanding interpersonal and conflict resolution skills Work well independently, while meeting aggressive deadlines and prioritizing multiple matters Collaborate closely with internal clients (including scientific and business leaders) with strategic transactions Have exceptional oral and written communication skills Maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations and protecting Regeneron's interests Work effectively and expertly with colleagues & clients in a collaborative environment Collaborate and advise key stakeholders, including senior management, on contracts group policies and procedures To be considered for this position, you must possess: A solid understanding of commercialization, contracts and related law within the biotech/pharmaceutical industry. JD with excellent law school credentials; licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. At least 5 to 10 years of legal experience at a law firm and/or in-house, including biotech/pharmaceutical and/or health care experience. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: The Regulatory Operations Associate Director is responsible for providing publishing, document processing, archiving and general submission support to the growing Regulatory Operations team. This person will help to establish the Regulatory Operations Function at Arcus and help to establish an approach for regulatory submissions. This position will provide global support to Regulatory Affairs with an immediate focus on work on submissions for the US. This person will collaborate closely with other Regulatory teams to establish the Regulatory Operations department. This person will manage the Publishing, Document Processing, and Archiving Functions. Job Responsibilities: Regulatory Operations Duties As the lead of the Regulatory Operations team, helping to establish the team and the sub functions within Arcus. Manage complex submission publishing activities associated with generating hard copy and electronic submissions. This will include working with offsite vendors and resources to produce quality dossiers. Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions. Lead strategic processes and provides strategic value to the overall positioning of the department with Arcus Lead and promotes initiatives in moving the company forward with the implementation of new systems, processes and services. Allocate project resource within the company and with offsite vendors to ensure adequate resourcing for Arcus regulatory dossiers Responsible for forward planning of Publishing resources. Has an awareness of long-term filing plans and advises senior management of resource implications. Interacts frequently with other functional areas such as IT, Clinical Operations, and Regulatory. Maintains constructive and positive interactions with colleagues. Manages multiple projects. Maintains oversight of the status of multiple projects managed by junior colleagues. Participates in cross-functional projects. Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution. Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts. Represent Regulatory Operations by taking the lead in submission planning meetings to help becoming familiar with the submission priorities. Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content. Assist and/or provide training to others on software tools and educate authors on publishing policies and procedures such as StartingPoint document templates, best practice for use in the Veeva Vault RIM platform and eCTD Viewing in Rosetta Viewer. Maintain a compliant and up-to-date Regulatory Archive using Veeva Vault Archive. Develop and training on archiving process as necessary Lead the development and management of projects as applicable in support of the Regulatory Operations department. Manage and develop junior members of staff. Management Duties Task management and performance management of junior employees will be required, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings. Identifies future resourcing needs, requests requisitions with justification, reviews CVs, telephone screens, arranges face-to-face interviews with department administrator, gathers feedback and recommends the successful candidate. Manage vendor relationships including required resources, issue resolution and contract negotiation. Qualifications (including knowledge & skills): Minimum education and experience level 10+ years of relevant experience and a BA or BS or 8+years with Master or above Preferred qualifications Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge. Management experience is preferred. Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook. Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required Experience with archive management Experience with vendor management is a plus Strategic thinking is required, with a focus on process improvement and optimization. Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills. Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers' expectations. Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations. Familiarity with pharmaceutical development and global Regulatory submissions is required. Organized with systematic approach to prioritization Process orientated to achieve the business objective Ability to learn new technologies quickly
03/01/2021
Full time
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: The Regulatory Operations Associate Director is responsible for providing publishing, document processing, archiving and general submission support to the growing Regulatory Operations team. This person will help to establish the Regulatory Operations Function at Arcus and help to establish an approach for regulatory submissions. This position will provide global support to Regulatory Affairs with an immediate focus on work on submissions for the US. This person will collaborate closely with other Regulatory teams to establish the Regulatory Operations department. This person will manage the Publishing, Document Processing, and Archiving Functions. Job Responsibilities: Regulatory Operations Duties As the lead of the Regulatory Operations team, helping to establish the team and the sub functions within Arcus. Manage complex submission publishing activities associated with generating hard copy and electronic submissions. This will include working with offsite vendors and resources to produce quality dossiers. Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions. Lead strategic processes and provides strategic value to the overall positioning of the department with Arcus Lead and promotes initiatives in moving the company forward with the implementation of new systems, processes and services. Allocate project resource within the company and with offsite vendors to ensure adequate resourcing for Arcus regulatory dossiers Responsible for forward planning of Publishing resources. Has an awareness of long-term filing plans and advises senior management of resource implications. Interacts frequently with other functional areas such as IT, Clinical Operations, and Regulatory. Maintains constructive and positive interactions with colleagues. Manages multiple projects. Maintains oversight of the status of multiple projects managed by junior colleagues. Participates in cross-functional projects. Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution. Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts. Represent Regulatory Operations by taking the lead in submission planning meetings to help becoming familiar with the submission priorities. Interface with project managers, regulatory product managers, and/or content authors to provide guidance on submission preparation and content. Assist and/or provide training to others on software tools and educate authors on publishing policies and procedures such as StartingPoint document templates, best practice for use in the Veeva Vault RIM platform and eCTD Viewing in Rosetta Viewer. Maintain a compliant and up-to-date Regulatory Archive using Veeva Vault Archive. Develop and training on archiving process as necessary Lead the development and management of projects as applicable in support of the Regulatory Operations department. Manage and develop junior members of staff. Management Duties Task management and performance management of junior employees will be required, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings. Identifies future resourcing needs, requests requisitions with justification, reviews CVs, telephone screens, arranges face-to-face interviews with department administrator, gathers feedback and recommends the successful candidate. Manage vendor relationships including required resources, issue resolution and contract negotiation. Qualifications (including knowledge & skills): Minimum education and experience level 10+ years of relevant experience and a BA or BS or 8+years with Master or above Preferred qualifications Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge. Management experience is preferred. Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook. Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required Experience with archive management Experience with vendor management is a plus Strategic thinking is required, with a focus on process improvement and optimization. Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills. Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers' expectations. Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations. Familiarity with pharmaceutical development and global Regulatory submissions is required. Organized with systematic approach to prioritization Process orientated to achieve the business objective Ability to learn new technologies quickly
In this role, you will have the opportunity to work independently and collaboratively in an exciting young but growing company. Overall Description: The Associate Director/Sr. Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to remain compliant with U.S. FDA and global regulatory bodies. This position is responsible for planning, drafting, managing global regulatory submissions with personnel within and external to the company. This individual will work closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders to ensure regulatory success. Job Duties and Responsibilities: Responsibilities may include, but are not limited to: Manage the preparation and submission of briefing packages and coordinate the sections of INDs, IMPDs, CTAs, and NDAs/BLAs. Responsible for preparing and coordinating company responses to queries from health authorities. Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs. Provide expert guidance roll-out and implementation of new and ongoing regulatory activities to support company goals. Responsible for timely compilation of all necessary documents to support regulatory submissions. Ensure cross-functional alignment on regulatory strategies. Qualifications: Bachelor's degree in science or health field required; advance degree is a plus 5+ years experience in regulatory affairs, clinical drug development, manufacturing, or clinical related function in the pharmaceutical or biopharmaceutical industry Broad and strong understanding of international regulations and guidelines, as well as industry practices in clinical development of drug or biologic drugs. Experience with CTD/eCTD and life cycle management. In-depth knowledge of ICH requirements and US/EU regional requirements. Excellent attention to detail and accuracy. Excellent verbal, written, negotiation, and interpersonal communication skills are required.
03/01/2021
Full time
In this role, you will have the opportunity to work independently and collaboratively in an exciting young but growing company. Overall Description: The Associate Director/Sr. Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to remain compliant with U.S. FDA and global regulatory bodies. This position is responsible for planning, drafting, managing global regulatory submissions with personnel within and external to the company. This individual will work closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders to ensure regulatory success. Job Duties and Responsibilities: Responsibilities may include, but are not limited to: Manage the preparation and submission of briefing packages and coordinate the sections of INDs, IMPDs, CTAs, and NDAs/BLAs. Responsible for preparing and coordinating company responses to queries from health authorities. Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs. Provide expert guidance roll-out and implementation of new and ongoing regulatory activities to support company goals. Responsible for timely compilation of all necessary documents to support regulatory submissions. Ensure cross-functional alignment on regulatory strategies. Qualifications: Bachelor's degree in science or health field required; advance degree is a plus 5+ years experience in regulatory affairs, clinical drug development, manufacturing, or clinical related function in the pharmaceutical or biopharmaceutical industry Broad and strong understanding of international regulations and guidelines, as well as industry practices in clinical development of drug or biologic drugs. Experience with CTD/eCTD and life cycle management. In-depth knowledge of ICH requirements and US/EU regional requirements. Excellent attention to detail and accuracy. Excellent verbal, written, negotiation, and interpersonal communication skills are required.
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: The Senior Manager / Associate Director, Regulatory Affairs CMC will lead and provide support on a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential. The successful candidate will have oversight over the planning, preparation, and review of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. Job Responsibilities: Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of Arcus products in early-to-late development through interaction with multiple functions to create high quality regulatory submissions that support product development strategy. Author and review CMC modules of applications and amendments for submission, ensuring complete CMC content that meets current regional requirements. Author and review responses to health authority requests for information. Represent the Regulatory Affairs CMC function on assigned cross-functional project teams for all CMC related issues. Coordinate regulatory section revision and lead adjudication meetings. Review IND annual reports / DSURs, IMPD, IMPD amendments for CMC content accuracy and regulatory messaging. Evaluate proposed manufacturing changes for impact to existing filings and providing strategic regulatory guidance for optimal implementation of changes. Develop excellent relationships with internal functional groups and contract manufacturing organizations to effectively influence the implementation of optimum regulatory strategies. Resolve complex CMC issues by demonstrating in-depth understanding of the regulations and industry drug development processes. Qualifications (including knowledge & skills): Bachelor's degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. A Master's degree in Regulatory Science and/or RAC certification is preferred. At least 4 years of experience in Regulatory Affairs in addition to at least 6 years (Senior Manager) or 8 years (Associate Director) in a related CMC discipline in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP and development phases of product lifecycle). Strong working knowledge of US and EU regulatory requirements as well as ICH guidelines (CMC) for biologics and small molecules. Experience in preparation of clinical trial applications for pharmaceutical or biologic products in the US, Canada, and/or Europe using eCTD format. Outstanding interpersonal and communication (written and verbal) skills are required. Demonstrated ability to work within a cross-functional matrix team environment. Highly organized, independent, self-motivated, and able to meet deadlines. Strong experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Prefer experience in use of a validated Regulatory Information Management system such as Veeva RIM or other Veeva module (Veeva Vault).
03/01/2021
Full time
About us: Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world's largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the "rule book" has not yet been written. Job Summary: The Senior Manager / Associate Director, Regulatory Affairs CMC will lead and provide support on a variety of activities in the Regulatory Affairs department related to regulatory submissions and systems. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential. The successful candidate will have oversight over the planning, preparation, and review of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. Job Responsibilities: Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of Arcus products in early-to-late development through interaction with multiple functions to create high quality regulatory submissions that support product development strategy. Author and review CMC modules of applications and amendments for submission, ensuring complete CMC content that meets current regional requirements. Author and review responses to health authority requests for information. Represent the Regulatory Affairs CMC function on assigned cross-functional project teams for all CMC related issues. Coordinate regulatory section revision and lead adjudication meetings. Review IND annual reports / DSURs, IMPD, IMPD amendments for CMC content accuracy and regulatory messaging. Evaluate proposed manufacturing changes for impact to existing filings and providing strategic regulatory guidance for optimal implementation of changes. Develop excellent relationships with internal functional groups and contract manufacturing organizations to effectively influence the implementation of optimum regulatory strategies. Resolve complex CMC issues by demonstrating in-depth understanding of the regulations and industry drug development processes. Qualifications (including knowledge & skills): Bachelor's degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. A Master's degree in Regulatory Science and/or RAC certification is preferred. At least 4 years of experience in Regulatory Affairs in addition to at least 6 years (Senior Manager) or 8 years (Associate Director) in a related CMC discipline in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP and development phases of product lifecycle). Strong working knowledge of US and EU regulatory requirements as well as ICH guidelines (CMC) for biologics and small molecules. Experience in preparation of clinical trial applications for pharmaceutical or biologic products in the US, Canada, and/or Europe using eCTD format. Outstanding interpersonal and communication (written and verbal) skills are required. Demonstrated ability to work within a cross-functional matrix team environment. Highly organized, independent, self-motivated, and able to meet deadlines. Strong experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Prefer experience in use of a validated Regulatory Information Management system such as Veeva RIM or other Veeva module (Veeva Vault).