Associate Director, Medical Writing

Responsibilities

• Author and review documents including but not limited to clinical study reports, protocols, submission modules and regulatory briefing documents.
• Work with statisticians to check tables, figures and interpretation of results. Maintain document trackers and flag risks early to keep projects on schedule.
• Ensure documents meet regulatory requirements and internal quality standards.
• Operate in a matrix team and build strong working relationships with internal stakeholders and external authors.
• Provide clear, constructive feedback and support continuous learning in the team.
• Mentor and coach medical writers and develop training materials for the team.

• MSc in life sciences or pharmacology.
• Significant experience in medical writing, specifically in clinical pharmacology, pharmacokinetics, writing for early phase clinical research.
• Development of Clinical Pharmacology Sections for Regulatory Submissions. Lead the authoring and development of Module 2.7.1 (Summary of Biopharmaceutics) and Module 2.7.2 (Summary of Clinical Pharmacology Studies), ensuring scientific accuracy, regulatory compliance, and alignment with program strategy.
• Collaborate with Medical Writers to integrate pharmacokinetic (PK) and pharmacodynamic (PD) data into cohesive, submission‑ready summaries by performing content and scientific review of these deliverables. Provide expert input into the PK and PD sections of clinical study protocols, clinical study reports (CSRs), and relevant appendices.
• Proven expertise in training, coaching, and capability development. Deliver training sessions and scientific mentoring to medical writers to strengthen understanding of clinical pharmacology principles.
• Strong project management skills and ability to deliver multiple documents on tight timelines.

• Advanced degree such as PhD, Pharm
  
  D in pharmacology.
• Proficient with Lean Writing principles.
• Support capability‑building initiatives by developing guidance/training materials, best practices, and knowledge resources.
• Technical Knowledge:
  Strong understanding of drug development processes, PK/PD, and regulatory guidelines (FDA, EMA).
• Writing
  
  Skills:
  
  Excellent English written communication, with the ability to translate complex data into regulatory‑grade documents.

5th March 2026 (COB)

Please take a copy of the

Job Description , as this will not be available post‑closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

If you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at UKRe
.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.