GlaxoSmithKline
Associate Director, GRA Precision Medicine & Digital Health
GlaxoSmithKline, Waltham, Massachusetts, United States, 02254
Site Name:
USA - Massachusetts - Waltham, Rockville Vaccines, UK – London – New Oxford Street, Upper Providence, Wavre Posted Date:
Nov 20 2024 Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. Responsibilities and Accountabilities: Accountable to GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. Planning will be on a multiple year horizon, requiring extensive matrix working within GSK to VP level and representing GSK with Precision Medicine/Digital Health partners and regulatory agencies. Build and maintain the team’s book of work. Work closely with members of the Regulatory Operations, Precision Medicine, and Unit Digital Health teams. Lead or participate in interactions with local/regional regulatory authorities. Key Responsibilities: Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. Lead regulatory interactions and the review processes for GSK. Ensure compliance with regulatory requirements at all stages of product life from C2MD. Advocate persuasively approaches to senior leaders in GSK and in Health Authorities. Provide assessment of Precision Medicine and Digital Health components leveraged for potential in-license molecules. Basic Qualifications: BS in biological science, healthcare science, or engineering. Minimum of 1 year experience in regulation of in vitro diagnostics, companion diagnostics and/or SaMD within a pharmaceutical company in at least one major market. Minimum of 1 year experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in at least one major market. Preferred Qualifications: MS or PhD in a biological science, healthcare science or engineering. Led global development, submission, and approval activities. Organized and executed milestone meetings with Health Authorities. Excellent communication skills, ideally in writing and verbally. Proven ability to foster strong matrix working and facilitate groups of individuals to work together on creating solutions. Ability to proactively recognize and resolve conflict and arbitrate as necessary. Proven ability to derive creative solutions to regulatory problems while ensuring compliance with regulation in all regions. Proven ability to take sound decisions, often without complete information. Why GSK? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and adheres to Affirmative Action principles.
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USA - Massachusetts - Waltham, Rockville Vaccines, UK – London – New Oxford Street, Upper Providence, Wavre Posted Date:
Nov 20 2024 Ensure the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. Responsibilities and Accountabilities: Accountable to GRL and Global Regulatory Science Precision Medicine Head for development of appropriate regional Precision Medicine and Digital Health regulatory strategy(s) and their timely delivery. Planning will be on a multiple year horizon, requiring extensive matrix working within GSK to VP level and representing GSK with Precision Medicine/Digital Health partners and regulatory agencies. Build and maintain the team’s book of work. Work closely with members of the Regulatory Operations, Precision Medicine, and Unit Digital Health teams. Lead or participate in interactions with local/regional regulatory authorities. Key Responsibilities: Ensure the development of appropriate global Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital health asset(s) supporting across the GSK therapeutic portfolio. Lead regulatory interactions and the review processes for GSK. Ensure compliance with regulatory requirements at all stages of product life from C2MD. Advocate persuasively approaches to senior leaders in GSK and in Health Authorities. Provide assessment of Precision Medicine and Digital Health components leveraged for potential in-license molecules. Basic Qualifications: BS in biological science, healthcare science, or engineering. Minimum of 1 year experience in regulation of in vitro diagnostics, companion diagnostics and/or SaMD within a pharmaceutical company in at least one major market. Minimum of 1 year experience with clinical trial and licensing requirements for Precision Medicine and Digital Health Products in at least one major market. Preferred Qualifications: MS or PhD in a biological science, healthcare science or engineering. Led global development, submission, and approval activities. Organized and executed milestone meetings with Health Authorities. Excellent communication skills, ideally in writing and verbally. Proven ability to foster strong matrix working and facilitate groups of individuals to work together on creating solutions. Ability to proactively recognize and resolve conflict and arbitrate as necessary. Proven ability to derive creative solutions to regulatory problems while ensuring compliance with regulation in all regions. Proven ability to take sound decisions, often without complete information. Why GSK? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together. We prevent and treat disease with vaccines, specialty and general medicines. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and adheres to Affirmative Action principles.
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