Principal Medical Writer

GSK; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

GSK is seeking a Principal Medical Writer in Durham. This role focuses on leading high-quality medical writing for complex clinical and regulatory projects. Candidates must have a bachelor's degree in life sciences and 5+ years of experience in the pharmaceutical industry.

The position involves managing writing projects, coordinating various contributors, and ensuring documents meet regulatory standards. Preferred qualifications include advanced degrees and experience with regulatory submissions. Join a diverse team at GSK and make an impactful contribution.

Qualifications

• 5+ years of experience in medical or regulatory writing in the pharmaceutical industry.
• 3+ years of experience with regulatory dossier development.
• Strong understanding of ICH guidelines and GCP.

Responsibilities

• Lead authoring and strategic planning for clinical and regulatory documents.
• Manage end-to-end writing projects and coordinate contributors.
• Translate complex clinical data into clear scientific narratives.

Skills

Medical writing

Regulatory writing

Clinical data interpretation

Project management

Strong verbal and written communication

Education

Bachelor's degree in life sciences

Advanced degree (PhD, PharmD, MPH, MS)

Job description

Site Name: Durham Blackwell Street, UK - London - New Oxford Street

Posted Date: Jun 10 2026

ViiV Healthcare is a global specialty HIV company committed to researching and delivering new medicines for people living with, and at risk of, HIV. We focus on education, prevention, treatment, and community support.

We seek a Principal Medical Writer to 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. The role offers visible impact and professional growth aligned with our mission.

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.

Basic Qualifications

• 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.

Preferred Qualifications

• 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.

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.