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.