Senior Medical Writer - Regulatory Focus

Elevate your career as a Senior Medical Writer in Kimberley! This role focuses on producing clear, accurate documents that facilitate regulatory submissions and scientific discussions.

Ideal candidates will bring at least five years of experience in Medical Writing within the pharmaceutical or biotechnology industry. You will collaborate with R&D, regulatory affairs, and clinical operations teams to ensure accurate and timely document creation. Your expertise in therapeutic areas and regulatory guidelines is vital for this position.

Key Responsibilities:

• Write and review regulatory submission documents and reports

• Maintain compliance with applicable ICH and FDA guidelines

• Collaborate closely with cross-functional teams for alignment

• Manage budgets and timelines effectively

• Mentor junior writers and refine internal documentation processes

Requirements:

• Bachelor's degree in a life or health science; advanced degree preferred

• 5+ years of relevant Medical Writing experience

• Expertise in clinical trial and publication standards

• Exceptional organizational and project management skills

• Proficient with Microsoft Office and document management tools

Shape the future of medical communication as a Senior Medical Writer with essential regulatory focus.