Director, Medical Writing Lead

• Lead team of medical writers on best practices in medical writing and regulatory submission processes
• Contribute to design of new operating model for medical writing
• Work closely with the reg digital team to explore and assess new technologies such as generative AI and automation
• Accountable for the successful planning and implementation of all clinical and regulatory written components of global regulatory submissions across one or more development programs
• Provide overall oversight, review, and approve study-level documentation required for clinical trials, submission documents and other reports intended for regulatory interactions
• Execute cross-functional process improvement initiatives on document standards, template development, and document processes
• Facilitate systems and best-practices for training multidisciplinary colleagues participating in document authorship
• Provide oversight for the quality and compliance of written components to company standards as well as regulatory requirements through oversight of the clinical quality control function
• Collaborate with clinical and regulatory teams to establish optimal interfaces to enable efficient and thorough authorship/revision of key technical documents and oversight of diverse regulatory submission documents to support regulatory filings
• Partner with other cross-functional leadership to ensure rapid identification of risks, issues, and development of potential solutions to maintain filing timelines and quality
• Manage and coordinate budget and resources to ensure on schedule completion of medical writing deliverables, including the identification, selection, and oversight of qualified full- or part-time medical writers, vendors, consultants, or contractors
• Oversee cross-functional collaborations and document review process for the medical writing team
• Represent Medical Writing as ad hoc member on Clinical Development Team (CDT) or Core Team (CT)
• Protocol Review Committee (PRC)
• Review document templates and standard operating procedures (SOPs)
• Maintain best practices in medical writing (e.g., regulatory style guide) to enhance efficiency, quality, and compliance with industry standards. processes, including documentation standards and timelines
• Maintain up-to-date knowledge of industry trends and regulatory changes and provide oversight to ensure that standards are being applied through review of documents produced by other team members

• Undergraduate degree and at least 13 years of relevant experience in medical writing, the pharmaceutical industry, and/or clinical research
• Advanced scientific degree and at least 10 years of relevant experience
• Deep expertise in global regulatory submissions, including IND/CTA and NDA/MAA preparation, document strategy, and lifecycle management
• Proven experience leading document strategies and submission activities across one or more development programs
• Experience across diverse organizational settings (pharma, biotech, and CRO) is preferred
• Advanced knowledge of global regulatory standards
• Strong leadership and people management capabilities
• Ability to manage multiple complex projects under tight timelines
• Exceptional communication and influencing skills
• Demonstrated expertise in outsourcing and resource management
• Strong problem-solving abilities
• Operational rigor
• Native or near-native English proficiency

Experience across diverse organizational settings (pharma, biotech, and CRO)

• Be part of a growing, innovation-driven company entering new therapeutic areas
• Work on global, high-impact projects shaping access to cutting-edge specialty medicines
• Collaborate with a diverse team of scientific and commercial experts
• Enjoy a high level of autonomy and strategic influence within a global organization
• Opportunities for career growth, international exposure, and leadership development