Sr. Director, Medical Writing – Biologics
The Sr. Director, Medical Writing – Biologics will provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting the late-stage development and anticipated commercialization of SAB’s lead biologic candidate, SAB-142, and broader pipeline programs. This role requires deep expertise in biologics regulatory writing, including leadership of Biologics License Applications (BLA), Marketing Authorization Applications (MAA), clinical study reports (CSRs), and global regulatory submissions to the FDA, EMA, and other international health authorities. The ideal candidate will bring extensive experience supporting late-phase biologics programs within agile biotech environments, with a demonstrated ability to drive submission readiness, support commercial launch planning, and partner cross-functionally to advance programs through regulatory approval and commercialization.
- Lead cross-functional development of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) to support global regulatory submissions and benefit-risk assessments.
- Provide strategic leadership for submission readiness activities, including pre-BLA planning, regulatory milestone preparation, and inspection-ready documentation strategies.
- Experience operating within lean, fast-paced biotech environments with high individual accountability and accelerated submission timelines.
Duties and Responsibilities (Include but are not limited to):
- Lead medical writing activities for biologic products across clinical development and regulatory submission programs.
- Author, review, and finalize high-quality regulatory documents including:
- Biologics License Applications (BLA)
- Supplemental BLAs (sBLA)
- Integrated Summaries of Safety (ISS)
- Integrated Summaries of Efficacy (ISE)
- Marketing Authorization Applications (MAA)
- Clinical Study Reports (CSRs)
- Investigator Brochures (IBs)
- Protocols and protocol amendments
- Clinical summaries and overviews
- FDA and EMA briefing documents
- Responses to Health Authority questions
- Advisory Committee briefing materials
- Labeling negotiation and product information documents
- Submission gap assessments and remediation documentation
- Module 2 summaries and other CTD/eCTD components
- Direct and execute end-to-end medical writing strategy for global biologics regulatory submissions, including BLA, MAA, and lifecycle management activities.
- Influence and align cross-functional stakeholders across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacovigilance, Translational Sciences, CMC, and Executive Leadership teams to ensure consistent regulatory strategy and messaging. Ensure documents comply with ICH, GCP, FDA, EMA, and other global regulatory guidelines.
- Ensure consistency of scientific messaging, pooled data interpretation, and benefit-risk positioning across all submission components.
- Manage timelines, resources, and deliverables for complex submission activities. Lead submission readiness tracking, document planning, and cross-functional coordination for major filing milestones and regulatory deliverables.
- Drive consistency, quality, and strategic messaging across submission documents. Contribute to process improvements, document standards, templates, and medical writing best practices as SAB continues to scale.
- Provide vendor oversight to third party medical writers. Manage medical writer(s) who may be hired as SAB moves closer to BLA filing.
- Collaborate closely with Regulatory Operations and Publishing teams to ensure technically compliant, inspection-ready eCTD submissions across global regions. Actively participate in regulatory strategy discussions and provide writing expertise during agency interactions.
- Support key regulatory interactions including pre-BLA meetings, late-cycle reviews, advisory committee preparation, and re