Description
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives.
The Principal Medical Writer is a seasoned expert who owns complex safety writing deliverables end-to-end. In this role, they independently lead the authoring of high-impact safety documents,such as aggregate reports and Risk Management Plans (RMPs),translating complex safety data and analyses into clear, compelling outputs.
Responsibilities
- Independently lead preparation of complex clinical and post-market safety documents (e.g., DSURs, PSURs/PBRERs, ACOs, PADERs/PAERs, RMPs, and responses to regulatory authority questions).
- Operate effectively within a global, complex matrix organization, working autonomously and confidently influencing stakeholders on process discipline, quality standards, and “how” work should be done.
- Lead cross-functional teams to develop content strategy, coordinate contributions, manage review schedules and timelines, and ensure high-quality, fit-for-purpose documents.
- Provide oversight to co-authors, vendor writers, and teams of writers,serving as a mentor/buddy, ensuring the quality of contributions.
Basic Qualifications
- Bachelor’s degree in life sciences, health sciences, pharmacy, nursing or a related field.
- Minimum 5 years of advanced medical/regulatory safety writing experience in pharmaceutical, biotech or clinical research settings.
- Advanced understanding of, and ability to apply, statistical, regulatory and medical communication concepts.
- In-depth working knowledge of relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA).
Preferred Qualifications
- Advanced degree (PhD, PharmD, MSc, MPH) or equivalent scientific training.
- Advanced safety writing skills with expertise across most key safety document types.
- Comfort interpreting statistical outputs and collaborating with statisticians.
- Highly collaborative and capable of leading cross-functional, multicultural, and hybrid/distributed teams.
What you will gain
You will join a team focused on patient impact and continuous learning. You will develop technical and strategic skills in regulatory writing, submission planning and cross-functional collaboration.