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GSK

Principal Medical Writer
DurhamPermanentOn-SiteFull-TimeSenior

Posted 5 days ago

Description

About ViiV Healthcare
ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV Healthcare is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV.

Role Overview
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.

Key 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.

About GSK
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
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GSK

A global biopharma company uniting science, technology and talent to get ahead of disease

LondonPharmaceuticals1000+
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GSK

Pharmaceuticals

Work on medicines and vaccines transforming millions of lives. Collaborate with 66,800 people across science and clinical innovation to tackle cancer, HIV and infectious diseases at a company ambitious for patients and accountable for impact.