About This Role:
As the Head of Medical Writing, West Coast Hub (WCH), you will helm the functional oversight of complex development programs within Biogen’s emerging nephrology and immune-mediated disease portfolio. Leading the West Coast Hub Medical Writing team, you will be responsible for resource planning, vendor oversight, and providing strategic leadership. Your role is pivotal in contributing to the long-term growth of the department, ensuring that standard procedures are meticulously adhered to across various projects. This position is integral to maintaining Biogen’s high standards and driving forward our regulatory and clinical documentation processes, enhancing the overall business structure with your expertise and guidance.
What You’ll Do:
- Lead and advance the Medical Writing function for the West Coast Hub, establishing and maintaining standardized processes, policies, templates, and best practices to ensure consistency, quality, and regulatory compliance across all deliverables.
- Provide strategic and operational oversight of clinical and regulatory writing activities, including authoring and guiding the development of:
- Clinical summaries and overviews for global marketing applications (e.g., NDA/BLA/MAA)
- Clinical trial applications (INDs/CTAs)
- Key documents supporting clinical development programs (e.g., protocols, CSRs, briefing documents)
- Manage and develop the Medical Writing team, including performance management, mentorship, and career development, fostering a culture of accountability, continuous learning, and high-quality delivery.
- Oversee resource planning and allocation, ensuring appropriate balance of internal and external writing resources to meet portfolio demands, timelines, and quality expectations.
- Provide vendor oversight and ensure accountability for external medical writing partners, including deliverable quality, timelines, and adherence to company standards.
- Partner cross-functionally within R&D (e.g., Clinical, Regulatory, Biometrics, Safety) to drive timely delivery of high-quality documents that support program strategy and regulatory submissions.
- Drive continuous process improvement, identifying inefficiencies and leading the development and implementation of scalable, fit-for-purpose writing processes across the organization.
- Represent Medical Writing on cross-functional initiatives, including R&D governance forums and process improvement efforts, ensuring alignment of documentation strategies with broader organizational goals.
- Participate in cross-functional workstreams focused on advancing innovative tools and technologies to enhance the quality, efficiency, consistency, and speed of clinical and regulatory document preparation.
- Establish and enforce best practices for document planning and execution, including timelines, review processes, and team coordination, while providing direct document-level support and mentoring for complex or high-priority deliverables.
Who You Are:
You are a visionary leader with a deep understanding of medical writing and regulatory requirements. Your strategic mindset and ability to foster growth are complemented by a strong commitment to quality and compliance. You thrive in collaborative environments, working seamlessly with cross-functional teams to achieve common goals. Your dedication to continuous improvement and mentorship ensures that your team delivers high-quality, impactful work that drives organizational success.
Required Skills:
- Bachelor's degree in life sciences or health discipline required; advanced degree preferred.
- 12+ years' experience in the biopharmaceutical industry or equivalent transferrable skills.
- 8+ years of direct medical writing experience.
- Expertise in clinical and regulatory document requirements; prior BLA/NDA experience strongly preferred.
- Experience managing a team of writers to produce high-quality deliverables.
- Strong record of strategic influence, executive-level communication, and cross-functional leadership.
Preferred Skills:
- Advanced degree in relevant field.
- Prior experience with innovative tools and technologies in medical writing.
- Experience in process improvement initiatives within medical writing.
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Job Level: Management
