Director of Medical Writing

Director, Medical Writing

Remote Opportunity - Candidates are ideally based in PST or MST time zone

Meet has partnered with a late-stage biotech based in Redwood City that is looking for a Director of Medical Writing to join their team! Our client has an approved drug with multiple Phase II and Phase III trials across metabolism/endocrinology, oncology, and neurology. You will be reporting into the Senior Director of Medical Writing.

Key Responsibilities

• You will author, co-author, and edit clinical + regulatory documents including IND's, NDA's, CSR's, protocol amendments, IB's, and other documents as needed.
• You will interact with cross-functional leaders to acquire relevant information for assigned documents (Clin Ops, Clin Dev, Regulatory Affairs, PM, CMC, Drug Safety...)
• You will have the opportunity to manage a small team of in-house medical writers
• You will be responsible for managing MW timelines to ensure on-time deliverables

Key Qualifications

• 8+ years of Medical Writing experience, in-house experience highly preferred
• Advanced degree (MS, PharmD, PhD) highly preferred
• Experience in oncology, metabolism, or neurology highly preferred
• Experience authoring major submissions (IND/NDA/BLA) required
• Prior leadership experience highly preferred (full-time, direct reports ideal)

Please reach out to Ryan Moran to learn more:

✉: ryan.moran@peoplewithchemistry.com