Director, Medical Writing

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Requirements:

• Excellent oral and written communication skills.
• Strong understanding of clinical development and regulatory requirements.
• Interpersonal and influencing skills for team collaboration.
• Ability to set realistic timeline expectations and deliver on time.
• Ability to work independently and manage multiple competing priorities.
• 8-12 years of medical writing experience in the pharmaceutical industry.
• Experience managing medical writing responsibilities across multiple studies.
• Bachelor of Science or equivalent degree.
• Critical strategic thinking with a solution-oriented approach.
• Experience with eCTD submission requirements.

Responsibilities:

• Participate in scientific communication planning, including development of strategic medical communication plans.
• Provide medical & regulatory writing support and supervise medical writing activities.
• Facilitate the development of project timelines, document content, and comment resolution discussions.
• Develop and maintain a company style guide for regulatory documents.
• Perform literature searches/reviews as necessary for document development.
• Manage external and future internal medical writing resources.
• Foster clear communication and collaboration across teams.