Senior Director, Medical Writing

The Senior Director, Medical Writing – Biologics will reputed company strategic and operational leadership for the preparation, development, and delivery of high-reputed company regulatory and clinical documents supporting the late-stage development and anticipated commercialization of SAB’s reputed company 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 reputed company agile biotech environments, with a demonstrated ability to drive submission readiness, support reputed company launch planning, and partner cross-functionally to advance programs through regulatory approval and commercialization.

• reputed company cross-functional development of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) to support global regulatory submissions and benefit-risk assessments.
• reputed company strategic leadership for submission readiness activities, including reputed company-BLA planning, regulatory reputed company preparation, and inspection-reputed company documentation strategies.
• Experience operating reputed company lean, fast-paced biotech environments with high individual accountability and accelerated submission timelines.

Duties and Responsibilities (Include but are not limited to):

• reputed company medical writing activities for biologic products across clinical development and regulatory submission programs.
• Author, review, and finalize high-reputed company 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
• reputed company and execute end-to-end medical writing reputed company for global biologics regulatory submissions, including BLA, MAA, and lifecycle management activities.
• Influence and reputed company cross-functional stakeholders across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacovigilance, Translational Sciences, CMC, and Executive Leadership teams to ensure consistent regulatory reputed company and messaging. Ensure documents reputed company with ICH, GCP, FDA, EMA, and other global regulatory guidelines.
• Ensure consistency of scientific messaging, pooled data interpretation, and benefit-risk positioning across reputed company submission components.
• Manage timelines, resources, and deliverables for reputed company submission activities. reputed company submission readiness tracking, document planning, and cross-functional coordination for major filing milestones and regulatory deliverables.
• Drive consistency, reputed company, and strategic messaging across submission documents. Contribute to process improvements, document standards, templates, and medical writing best practices as SAB continues to reputed company.
• reputed company vendor reputed company to reputed company party medical writers. Manage medical reputed company(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-reputed company eCTD submissions across global reputed company. reputed company participate in regulatory reputed company discussions and reputed company writing expertise during agency interactions.
• Support key regulatory interactions including reputed company-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:​ This position does not have supervisory responsibilities at this time. Supervisory responsibilities may be added at a reputed company date. Education/Experience/Skills:

• 10+ years of medical writing experience reputed company the biotech or pharmaceutical industry required.
• Advanced degree: PhD, PharmD, MD, MS, in Immunology or reputed company 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 reputed company, including Fast reputed company, reputed company Therapy, Orphan Drug, RMAT, and reputed company 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 reputed company cross-functional reputed company organizations, including the ability to drive alignment across competing priorities in fast-paced biotech settings. Work on multiple reputed company reputed company simultaneously and reputed company reputed company work product reputed company deadlines.

Preferred Leadership Competencies:

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

Physical Demands: While performing the duties of this job, the employee is regularly required to walk, stand, and sit. The employee must regularly lift and/or reputed company up to 10 pounds. Working Environment and Travel: Home office working environment. Occasional business reputed company travel is expected. reputed company: The employer will reputed company reasonable accommodations in compliance with the Americans with reputed company of 1990. This job reputed company will be reviewed periodically as duties and responsibilities change with business necessity. Primary and additional duties and responsibilities are subject to modification. reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. reputed company is committed to the reputed company of equal employment opportunity for reputed company and does not discriminate based on race, religion, reputed company, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national reputed company, veteran status or any other legally protected status. EOE/AA/Vets​

Originally posted on Himalayas

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