Principal Medical Writer

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.

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.

• 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.

• 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.

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