Principal Medical Writer

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

Benefits offered by this job

Comprehensive benefits program

Job summary

GlaxoSmithKline is seeking a Principal Medical Writer in Durham, NC to lead medical writing for complex clinical and regulatory projects. The ideal candidate will have 5+ years of experience in the pharmaceutical industry and a Bachelor's degree in life sciences.

This role requires strong collaboration and communication skills to work with cross-functional teams. Benefits include a comprehensive program for US employees, along with opportunities for professional growth.

Qualifications

• 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.
• Strong understanding of ICH guidelines and Good Clinical Practice (GCP).

Responsibilities

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

Skills

Medical writing

Regulatory writing

Communication

Collaboration

Education

Bachelor’s degree in life sciences

Job description

Principal Medical Writer

ViiV Healthcare, a global specialty HIV company, 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. 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.

We value scientific rigor, clear communication, collaboration, and ownership.

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.

Benefits

Learn more about the comprehensive benefits program GSK offers US employees. Please visit GSK US Benefits Summary.

Equal Opportunity Employer

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, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.