Associate Director, Medical Writing
September 4
🏢 In-office - Bay Area
Description
• Collaborate to write high-quality medical-writing deliverables supporting regulatory requirements of clinical development programs • Author, co-author, critically edit, and format clinical/regulatory documents, including NDAs, protocols, CSRs • Interact with document authors, contributors, and reviewers to acquire necessary input • Develop and manage medical writing timelines for assigned documents • Facilitate comment resolution and adjudication with authors, reviewers, and project teams • Oversee vendors and contractors • May include management of in-house medical writing staff • Serve as functional area representative on project teams advising on content, format and style • Lead the development/refinement of medical writing processes and quality control • Interview, mentor, and assist in integration of medical writing staff as needed • Maintain subject area expertise related to investigational products and regulatory 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
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