Director, Medical Writing

About the role

The Director, Medical Writing provides strategic and operational leadership for the Medical Writing function and is responsible for the planning, development, and delivery of high-quality clinical and regulatory documents that support BBOT's development programs and global regulatory submissions.

Responsibilities

• Medical Writing
  • Direct, hands-on authoring and leading complex, major regulatory document preparation (e.g., IND, NDA, BLA, and MAA, clinical protocol, IB, CSR, Agency meeting materials).
  • Synthesize complex clinical and scientific data into key elements.
  • Review and edit documents prepared by internal writers, contractors, or functional contributors to ensure quality and adherence to standards.
  • Partner with study teams to develop key messages from clinical study data.
  • Drive alignment across functions to ensure high-quality, timely, and efficient execution of clinical and regulatory documentation.
• Functional Leadership and Strategy
  • Develop and execute the Medical Writing functional strategy aligned with corporate and development objectives.
  • Establish and maintain department goals, performance metrics, standards, and best practices to ensure high-quality and efficient document delivery.
  • Build, scale, and continuously improve Medical Writing processes, systems, templates, and standards.
  • Provide strategic leadership and oversight for all medical writing activities across the clinical portfolio.
  • Serve as the functional leader and subject matter expert for Medical Writing within the organization.
• Portfolio and Regulatory Leadership
  • Lead strategic planning and oversight of medical writing deliverables across all development programs and regulatory submissions.
  • Influence development and regulatory strategies through active participation in portfolio planning and decision-making activities.
  • Develop integrated document strategies and submission plans for major regulatory submissions, including INDs, NDAs, BLAs, MAAs, and health authority meeting packages.
  • Partner with cross-functional teams to develop messaging strategies and ensure consistent communication of clinical data across regulatory documents.
  • Provide strategic guidance on document content, structure, and messaging to support successful regulatory interactions and submissions.
  • Ensure all deliverables are completed in compliance with applicable regulations, company SOPs, ICH guidelines, and industry standards.
• Organizational Leadership and Resource Management
  • Develop and manage Medical Writing resource plans, including internal staffing, contractor oversight, and vendor management strategies.
  • Manage departmental budgets and forecasting activities to ensure efficient allocation of resources.
  • Recruit, mentor, develop, and retain high-performing medical writing professionals.
  • Provide leadership, coaching, and performance management for direct reports and contribute to succession planning and organizational development.
  • Establish an effective operating model that supports organizational growth and evolving business needs.
• Quality and Compliance
  • Establish and maintain Medical Writing governance, standards, templates, and quality processes.
  • Ensure inspection readiness and compliance with global regulatory requirements, including FDA, EMA, ICH, and GCP guidelines.
  • Oversee quality review processes to ensure scientific accuracy, consistency, and regulatory compliance across all documents.
  • Lead continuous improvement initiatives that enhance efficiency, quality, and scalability of Medical Writing operations.

Qualifications

• Bachelor's degree in Life Sciences or related discipline required; advanced degree (PhD, PharmD, MD, or Master's degree) preferred.
• Minimum of 12 years of experience in the biopharmaceutical industry, including at least 10 years of progressive medical writing experience.
• Minimum of 3 years of people leadership or functional management experience.
• Demonstrated success leading Medical Writing activities for complex global regulatory submissions, including INDs, NDAs, BLAs, and MAAs.
• Extensive knowledge of global regulatory requirements and guidelines, including FDA, EMA, ICH, and GCP.
• Proven experience building and managing medical writing teams, contractors, and external vendors.
• Demonstrated ability to independently lead in a fast-paced, dynamic, and highly collaborative biotechnology environment.
• Strong strategic thinking, organizational, and project leadership skills.
• Excellent written and verbal communication skills and the ability to influence at all levels of the organization.
• Proficiency with standard business applications and industry systems, including Microsoft Office, Adobe Acrobat, SharePoint, Veeva RIM, EndNote, and related document management platforms.