Director, Medical Writing

• 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.

• 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 responses to agency information requests.
• Support lifecycle management activities including supplemental filings, annual reports, post-marketing commitments, and safety update documentation.
• Support due diligence activities for potential partnerships, licensing discussions, and investor-facing regulatory communications, as needed.

Supervisory Responsibilities:

• 10+ years of medical writing experience within the biotech or pharmaceutical industry required.
• Advanced degree: PhD, PharmD, MD, MS, in Immunology or related discipline
• Experience with successful FDA and EMA approvals for biologic products preferred but not required.
• Significant and demonstrated experience supporting biologic drug development programs through medical writing activities.
• Demonstrated hands-on experience authoring and leading BLA and MAA submissions is required. Demonstrated experience leading late-stage regulatory submission activities through filing, review, and approval phases is strongly preferred.
• Experience supporting expedited regulatory pathways, including Fast Track, Breakthrough Therapy, Orphan Drug, RMAT, and Priority Review, preferred.
• Proven experience in preparing and managing:
  • Clinical Study Reports (CSRs)
  • FDA regulatory dossier submissions
  • Global regulatory submissions for biologic products
  •  Integrated summaries (ISS/ISE)
  • NDA/BLA submission readiness and governance activities
  • Advisory Committee preparation support
• Strong knowledge of:
  • FDA and EMA regulatory requirements
  • ICH guidelines
  • CTD/eCTD structure and submission standards
  • Deep understanding of late-stage clinical development and commercialization transition activities for biologic products.
• Demonstrated leadership and influence within cross-functional matrix organizations, including the ability to drive alignment across competing priorities in fast-paced biotech settings. Work on multiple complex projects simultaneously and provide quality work product within deadlines.

• Strong regulatory judgment and ability to proactively identify submission risks and mitigation strategies.
• Ability to synthesize complex scientific and clinical data into clear, concise, and strategically aligned regulatory narratives.
• Experience operating successfully in lean biotech organizations with evolving priorities and compressed timelines.
• High degree of ownership, accountability, and execution focus.
• Excellent written scientific writing, editing, and communication skills.  Ability to verbally articulate scientific and related information to wider groups and stakeholders.

Powered by JazzHR