Associate Director Medical Writing

Role Overview: As an Associate Director, Safety Writing at GSK, you will be responsible for leading the safety writing team and ensuring accurate, clear, and compliant preparation of Aggregate Reports and Risk Management Plans (RMP). Your role will involve managing a team of in-house medical writers, providing oversight and input into all aspects of aggregate reports and RMP preparation, and driving key organizational process improvement initiatives. Your contribution will play a crucial role in impacting the health of millions of people worldwide. Key Responsibilities: - Manage a team of 8-10 in-house medical writers to develop aggregate reports and RMPs in scope to support delivery of the portfolio. Identify needs for development and capability expansion of team members. - Ensure medical writers are trained in relevant procedures, policies, and standards for safety writing activities. Lead the development of training materials and provide mentoring and coaching to individuals or teams. - Evaluate resources required for safety writing activities to align with organizational objectives. Provide project updates to leadership and propose solutions for shifting timelines and staffing requirements. - Interface with cross-functional safety teams and third parties to ensure appropriate input and alignment for the resourcing and generation of safety reports. - Drive and implement key organizational process improvement initiatives, generate ideas for improvement, and promote an empowering environment for idea generation. - Provide leadership, strategic planning, delegation of responsibilities, and tasks. Monitor project progress and assess overall performance. - Measure and monitor efficiency and quality of the team's output, collect and evaluate metrics to identify the need for process improvement. Qualification Required: - Minimum qualification required is a master's degree in Life Sciences/Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.). A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine is advantageous. - 6-8 years of experience in safety writing, including leading the development of safety reports in a post-market setting within the pharmaceutical/Contract Research Organization industry. Company Details: GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. With a focus on impacting the health of 2.5 billion people by the end of the decade, GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing. The company's innovative approach to discovering and delivering vaccines and medicines aims to transform lives and accelerate significant assets that meet patients" needs with the highest probability of success.,