Senior Director of Medical Writing – Remote* (In office/1x per month/San Franisico)

Our Client: A late-stage biopharmaceutical company leading advancements in fibrotic disease therapies.

About the Role:

Our client is seeking a Senior Director of Medical Writing to spearhead the development of regulatory and clinical documentation. This critical hire will lead the function, collaborate with cross-functional teams, and contribute to ongoing late-stage trials.

Responsibilities:

• Build and lead the medical writing team, including developing templates, processes, and SOPs.
• Author key documents such as NDA/MAA submissions, IBs, and CSRs.
• Partner with teams on protocol development and regulatory interactions.
• Mentor junior staff while taking a hands-on approach to deliverables.

Qualifications:

• PhD or MD degree in a scientific discipline.
• 15+ years of regulatory/clinical writing experience with pharma or biotech industry.
• 5+ years of management experience.
• Experience with global regulatory submissions and ICH/GCP guidelines.

Work Location:

Remote with travel to San Francisco Bay Area for on-site presence when needed 1x a month.

Base Compensation: $260 – $280k + Bonus + Equity