Senior Director, Medical Writing – Biologics

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver strategic and operational guidance for the preparation, development, and presentation of high-quality regulatory and clinical documents that support the late-stage development and anticipated commercialization of SAB’s primary biologic candidate, SAB-142, along with broader pipeline initiatives.

• Oversee the cross-functional development of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) to aid in global regulatory submissions and benefit-risk evaluations.

• Draft, review, and finalize high-quality regulatory documents, including Biologics License Applications (BLA), Marketing Authorization Applications (MAA), clinical study reports (CSRs), and responses to inquiries from Health Authorities.

⛳️ Requirements

• A minimum of 12 years of medical writing experience in biologics development within the biotech or pharmaceutical sector is required.

• An advanced degree such as a PhD, PharmD, MD, or MS in Immunology or a related field.

• Experience with successful FDA and EMA approvals for biologic products is preferred, though not mandatory.

• Significant and proven experience in supporting biologic drug development programs through medical writing activities.

• Demonstrated practical experience in authoring and leading BLA and MAA submissions is essential.

🏝️ Benefits

• A home office working environment.

• Occasional travel for business purposes is anticipated.