We are seeking a motivated and experienced Director or Senior Director of Medical Writing to lead cross-functional teams in preparing content for regulatory submissions. The role requires close collaboration with key stakeholders, applying expertise in scientific writing, data analysis, and understanding the full regulatory content lifecycle.

Responsibilities:

• Lead the development of clinical and regulatory documents (e.g., Protocols, Investigator Brochures, IND Reports, Briefing Documents) in alignment with applicable guidelines, standards/SOPs, and content management principles.
• Collaborate with functional leads to plan content and create timelines for the production of assigned documents.
• Manage and oversee medical writing activities across multiple projects and development programs, ensuring consistency and clarity across all documents.
• Ensure scientific integrity, formatting, and consistency of content within a product or clinical dossier, maintaining high standards across documents.
• Lead document adjudication meetings and resolve issues in collaboration with cross-functional teams.
• Oversee the document review and approval process, liaising with development partners as necessary.
• Act as the primary publishing contact for related projects.

Qualifications:

• Bachelor’s degree in life sciences.
• 8-10 years of relevant experience in the biotech/pharmaceutical industry, with at least 5 years in direct medical writing.
• Proven ability to produce high-quality, clear writing in English, with significant experience in preparing complex clinical and regulatory documents and global submissions.
• Experience in authoring and managing clinical/regulatory documents, such as protocols, clinical study reports, IND/NDA/MAA submissions, investigator brochures, briefing documents, and responses to regulatory queries.
• Strong project management skills, with experience leading complex projects in a fast-paced, matrix environment.
• Ability to influence without authority and facilitate the exchange of ideas among diverse teams.
• Proven ability to manage direct reports
• Understanding of cross-functional interdependencies (e.g., clinical pharmacology, biomarkers, health outcomes).
• Demonstrated flexibility in adapting priorities and behaviors to manage competing priorities in a dynamic environment.
• Excellent communication skills, including the ability to present ideas and data clearly to senior stakeholders.
• Familiarity with tools and strategies to expedite document preparation, including review tools and automation.