Lead Medical Writer — Regulatory Submissions & Strategy (Remote)

GlaxoSmithKline; Durham (NC); Sur place; USD 80 000 - 110 000; Plein temps

Résumé du poste

GlaxoSmithKline is seeking a Principal Medical Writer for their Durham office. The ideal candidate will lead complex medical writing projects and collaborate with cross-functional teams on regulatory submissions.

Key requirements include over 5 years in medical writing, expertise in regulatory documents, and a Bachelor’s degree in a relevant field. The position emphasizes scientific rigor and effective communication in a fast-paced environment.

GSK values diversity and encourages applicants from all backgrounds.

Qualifications

• 5+ years of experience in medical or regulatory writing within the pharmaceutical or healthcare industry.
• 3+ years of experience independently authoring clinical protocols and regulatory submission documents.
• Strong understanding of ICH guidelines and GCP.

Responsabilités

• Lead authoring and strategic planning for clinical and regulatory documents.
• Manage end-to-end writing projects and conducting quality checks.
• Translate complex clinical data into clear scientific narratives.

Connaissances

Medical writing

Regulatory writing

Project management

Clear communication

Collaboration

Formation

Bachelor's degree in life sciences or related field

Advanced degree (e.g., PhD, PharmD, MPH, MS)

Description du poste

GlaxoSmithKline is seeking a Principal Medical Writer for their Durham office. The ideal candidate will lead complex medical writing projects and collaborate with cross-functional teams on regulatory submissions.

Key requirements include over 5 years in medical writing, expertise in regulatory documents, and a Bachelor’s degree in a relevant field. The position emphasizes scientific rigor and effective communication in a fast-paced environment.

GSK values diversity and encourages applicants from all backgrounds.