• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Head of Medical Writing

Job Number: 34828

Location:

Job Description

The Head of Medical Writing reports to the Head of Development Operations and oversees medical writing strategies and operations for clinical development programs. They collaborate with cross-functional teams and external partners to ensure writing deliverables meet GCP, GDP, patient safety, and quality standards within regulatory requirements, contractual agreements, budgets, and timelines.

Responsibilities

  • Influence medical writing strategies and processes across functional areas.
  • Provide guidance on industry best practices and writing guidelines.
  • Lead the medical writing team for regulatory documents and clinical reports.
  • Coordinate document quality checks and adjustments based on feedback.
  • Maintain therapeutic area and regulatory knowledge.
  • Contribute to process improvements and project metrics development.
  • Coordinate scientific publication activities as needed.

Required Skills

  • Strong communication and interpersonal skills
  • Team player with excellent organizational abilities
  • Proficiency in medical or technical writing
  • Customer-focused and self-motivated
  • Result-oriented with project management skills
  • Analytical and data interpretation capabilities
  • BS/BA in a relevant field
  • 10+ years in pharmaceutical R&D, including 3-5 years as a Medical Writer
  • Technical expertise in document development
  • Proficient in Microsoft software and computer skills
  • Knowledgeable about ICH and global regulatory guidelines
  • Understanding of clinical trial design and regulatory processes
  • Experience in Pulmonary Arterial Hypertension (PAH) is advantageous.

 

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