Associate Director, Medical Writing

GSK•Upper Providence, PA

4d•Hybrid

About The Position

You will lead medical writing activities that support clinical development and regulatory submissions. You will work closely with clinical pharmacology, non-clinical, pre-clinical research, regulatory, biostatistics and/or external partners to plan, author and deliver complex documents. We value clear scientific judgement, practical project leadership and collaborative communication. This role offers growth, meaningful impact and alignment with our mission of uniting science, technology and talent to get ahead of disease together. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will 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.

Requirements

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.
Strong understanding of drug development processes, PK/PD, and regulatory guidelines (FDA, EMA).
Excellent English written communication, with the ability to translate complex data into regulatory-grade documents.

Nice To Haves

Advanced degree such as PhD, PharmD in pharmacology.
Proficient with Lean Writing principles.
Support capability-building initiatives by developing guidance/training materials, best practices, and knowledge resources.

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.