Careers

Director/Sr Director of Medical Writing

Summary of Position

ArriVent Biopharma is looking for a talented and highly motivated Director/Sr Director of Medical Writing to lead the development of high-quality, fit-for-purpose clinical and regulatory documents. This involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects, including for global marketing applications and initial new drug applications. This position reports to the Sr. Vice President of Regulatory Affairs. This position is remote; however, it will require working closely with a cross functional team based primarily in the San Francisco Bay Area and some travel to the office in Burlingame, CA.

Key responsibilities

Writes and edits CSRs, CTD summaries, protocols, investigators brochures, and other clinical trial documentation as necessary for submission to regulatory agencies and other stakeholders or for in-company use. Manages medical writing and documentation contributors

• Leads and manages teams of external medical writers in complex projects by providing guidance based on organizational goals and company policy, with responsibility for results.
• Serves as the MW expert on regular and ad hoc study, program, or project teams.
• Supports and directs the work of contract medical writers
• Provides asset-level strategic guidance to study-level MW representatives
• Guides and advises Medical Writing contributors as a function of program representation. This responsibility may include document review.
• Proposes and manages timelines for document preparation and review
• Performs quality checks of documents prepared by other medical writers as needed.
• Proposes opportunities for process improvement and leads projects to enhance efficiency and optimize the use of resources
• Integrates various sources of information into a uniform style and language for regulatory compliance.
• Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed
• Assembles CSR and CTD summary appendices and narratives, as needed
• Other duties as needed.

Desired Skills

• Good/general knowledge of the AMA Manual of Style, ICH guidelines, Regulatory Affairs, and Clinical Development.
• Excellent writing ability with strong attention to detail.
• Proficient in Windows suite.
• Ability to independently develop high-quality complex documents
• Directs a variety of complicated tasks with strategic context and problem solving approach
• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Has good general knowledge of other related disciplines.
• Has good timeline development and management skills
• Proficient in written, oral, and interpersonal communications
• Ability to manage complexity and uncertainty
• Ability to work in a small company within a largely virtual environment; small biotech/pharma experience
• Embraces company core values

Education & Experience

• BA/BS degree required in a biological/physical sciences or pharmacy. Advanced degree in related discipline preferred.
• 10+ years of medical writing experience in the biotech / pharmaceutical industry
• Experience in oncology
• Experience and significant participation in preparation of documents for regulatory submissions (e.g., clinical protocols, INDs, NDAs, BLAs, CTDs).