Principal Medical Writer

GSK•Durham, NC

1d•Onsite

About The Position

ViiV Healthcare is seeking a Principal Medical Writer who will lead and deliver high-quality medical writing for complex clinical and regulatory projects. You will work closely with clinical, regulatory, statistical, and cross-functional teams. We value scientific rigor, clear communication, collaboration, and ownership. This role offers visible impact, professional growth, and meaningful work that aligns with GSK’s mission of uniting science, technology and talent to get ahead of disease together.

Requirements

Bachelor’s degree in life sciences, health sciences, or a scientific field.
5+ years of experience in medical or regulatory writing within the pharmaceutical or healthcare industry.
3+ years of experience with regulatory dossier development and Common Technical Document (CTD) module documents.
3+ years of experience independently authoring clinical protocols, clinical study reports, and regulatory submission documents.

Nice To Haves

Advanced degree (e.g., PhD, PharmD, MPH, MS) in life sciences or a related field.
Experience leading regulatory submission projects, including Common Technical Document (CTD) dossiers.
Familiarity with statistical concepts and ability to interpret clinical data.
Strong problem-solving skills and ability to adapt to changing priorities.
Experience working in multicultural or remote team settings.
Proven ability to independently write and manage complex regulatory documents.
Strong understanding of International Council for Harmonization (ICH) guidelines and Good Clinical Practice (GCP).
Excellent written and verbal communication skills, with attention to detail.
Experience managing multiple projects and meeting deadlines in a fast-paced environment

Responsibilities

Lead authoring and strategic planning for clinical and regulatory documents, including protocols, clinical study reports, briefing documents, and submission dossiers.
Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards.
Translate complex clinical and statistical data into clear, accurate, and well-structured scientific narratives for diverse audiences.
Act as a subject matter expert on medical writing standards, document structure, and regulatory expectations.
Drive process improvement initiatives, support KPI tracking, and contribute to audit readiness and compliance activities.