Director, Medical Writing
May 2
🏢 In-office - Bay Area
Description
• Collaborate with colleagues to write high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements • Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, administrative letters, and other regulatory submissions as needed • Interact with document authors, contributors, and reviewers to acquire necessary input into documents • Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs • Facilitate comment resolution and adjudication with authors, reviewers, and project teams • Oversee vendors and contractors • May include management of in-house medical writing staff (based on experience and team need) • May serve as the functional area representative on project teams and advise such teams on content, format, and style requirements for documents • Participate in the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables • Assist in the interviewing, mentoring, and integration of medical writing staff as needed • Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines
Requirements
• Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines • Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness • Successful track record of working on complex clinical/regulatory writing projects across multiple therapeutic areas • Excellent attention to detail, multitasking, prioritization, and flexibility • Excellent communication skills with proven ability to interact in a cross-functional environment • Understanding of the drug-development process, including research and development processes and objectives and the required documents • Familiarity with US and European regulatory requirements and guidelines for documents; general knowledge of electronic Common Technical Document (e-CTD) requirements with respect to structure, format, and content • Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas • Proficiency in use of MS Office applications (Word, Outlook, Excel, PowerPoint), Adobe Acrobat, electronic document management systems (eg, Veeva Vault, Box, SharePoint), and templates (eg, StartingPoint). • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities • Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision • Ability to think strategically, be resourceful, and lead without formal authority
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