At a Glance
- Tasks: Lead high-quality medical writing for complex clinical and regulatory projects.
- Company: ViiV Healthcare, a mission-driven global HIV specialist.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Join a dynamic team focused on improving lives and advancing healthcare.
- Why this job: Make a real impact in the fight against HIV through innovative medical writing.
- Qualifications: Bachelor's degree in life sciences and 5+ years of medical writing experience.
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.
Principal Medical Writer Durham in North East employer: Meeveem Limited
ViiV Healthcare is an exceptional employer, dedicated to advancing HIV treatment and care, offering a collaborative work culture that fosters innovation and professional growth. Located in Durham, employees benefit from a supportive environment that encourages continuous learning and development, alongside competitive compensation and comprehensive benefits tailored to enhance work-life balance. Join us in making a meaningful impact on the lives of those affected by HIV while working with a passionate team committed to excellence.
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We think this is how you could land Principal Medical Writer Durham in North East
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