At a Glance
- Tasks: Lead authoring and strategic planning for clinical and regulatory documents, managing end-to-end writing projects.
- Company: ViiV Healthcare is a global specialty HIV company focused solely on HIV research and medicine delivery.
- Benefits: Work in a mission-driven environment dedicated to supporting people living with and affected by HIV.
- Other info: Experience with Common Technical Document (CTD) dossiers is essential.
- Why this job: Join a team that values process improvement and compliance in the healthcare industry.
- Qualifications: Requires a Bachelor's degree in life sciences and 5+ years of medical writing experience.
The predicted salary is between 70000 - 90000 £ per year.
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.
Principal Medical Writer in North East employer: Gsk
ViiV Healthcare, located globally, is committed to delivering innovative HIV medicines. The team focuses on collaboration across clinical, regulatory, and statistical domains, ensuring high-quality outputs. Employees benefit from a mission-driven culture that prioritises support for those affected by HIV.
