Director of Medical Writing
A company is looking for a Director of Medical Writing. Key Responsibilities Lead and manage the writing, review, and finalization of clinical development and regulatory documents Innovate and streamline regulatory writing processes in collaboration with tech team members Ensure compliance of documents with regulatory agency guidelines and manage timelines for completion Required Qualifications Bachelor of Science Degree required; advanced degree (MS or PhD) preferred 7+ years of experience in developing clinical and regulatory documents Experience as a lead writer for key clinical and regulatory documents Understanding of FDA/international regulations and ICH guidelines Experience mentoring or managing other writers preferred
A company is looking for a Director of Medical Writing.
Key Responsibilities
Lead and manage the writing, review, and finalization of clinical development and regulatory documents
Innovate and streamline regulatory writing processes in collaboration with tech team members
Ensure compliance of documents with regulatory agency guidelines and manage timelines for completion
Required Qualifications
Bachelor of Science Degree required; advanced degree (MS or PhD) preferred
7+ years of experience in developing clinical and regulatory documents
Experience as a lead writer for key clinical and regulatory documents
Understanding of FDA/international regulations and ICH guidelines
Experience mentoring or managing other writers preferred
