# Principal Medical Writer

**Company**: ViiV Healthcare
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Durham-Blackwell-Street/Principal-Medical-Writer_442725-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

ViiV Healthcare, a global specialty HIV company, is seeking a Principal Medical Writer to lead and deliver high-quality medical writing for complex clinical and regulatory projects.

The successful candidate will work closely with clinical, regulatory, statistical, and cross-functional teams, providing 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: GSK offers a comprehensive benefits program, which can be found at GSK US Benefits Summary.

## Skills

### Required
- Medical Writing
- Regulatory Submissions
- Scientific Writing
- Clinical Development
- Communication

### Nice to have
- Statistical concepts
- Problem-solving
- Influencing Without Authority
- Emotional Intelligence
- Learning Agility

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