Senior Director of Medical Writing
virtual vocationsDenver (CO)
Senior Director of Medical Writing
Posted 4 days ago
virtual vocationsDenver (CO)
SENIORITY
Manager
About the role
To support a growing biopharmaceutical company, the full-time Senior Director of Medical Writing will lead the development of clinical and regulatory documents, manage timelines and vendor relationships, and ensure compliance with health authority guidelines in a fully remote setting.
Key Responsibilities:
Author and oversee the development of clinical study protocols, reports, and related documents from concept to submission-ready status
Lead medical writing for regulatory submissions, including IND applications and briefing documents, ensuring adherence to regulatory standards
Manage document review processes and collaborate with cross-functional teams to resolve conflicting comments and ensure clarity in all communications
Required Qualifications:
Bachelor's degree in a life science; advanced scientific or medical degree preferred
10+ years of regulatory medical writing experience in the biotechnology or pharmaceutical industry
Proven lead-author experience on clinical documents such as protocols and study reports
Strong understanding of health authority regulations, ICH guidelines, and medical writing standards
Experience managing document timelines and collaborating with cross-functional teams
Before you apply
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A number in mind
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Your notice period
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