Director, Medical Writing

Key Responsibilties

• Oversees the Medical Writing deliverables for multiple programs and/or indications with a high degree of diversity and complexity, leading the document writing and review process for assigned projects to ensure quality and timely completion of deliverables, with attention to consistency of content, messaging, format, and style
• Author and manage authoring of Medical Writing documents together with cross-functional collaborators, including the development of strategic messaging and data presentation, in accordance with Cerevel standards and health authority requirements
• Lead Medical Writing activities for assigned program(s) and indications, including resource planning, document timelines, budget forecasting/utilization, and issue resolution
• Manage and/or mentor more junior medical writers, as needed. Manage internal/external Medical Writing resources for assigned program(s) and indications
• Manage internal/external resources for broad cross-program Medical Writing department deliverables or initiatives (eg, for disclosures and transparency, QC, CSR narratives), as needed
• Represent Medical Writing on interdisciplinary teams for assigned programs and provide strategic input (both Medical Writing and therapeutic area expertise) and status updates
• Participate in continuing education, networking, and intelligence gathering opportunities for process improvement initiatives or implementation of new technologies
• Lead the development of Medical Writing-relevant cross-functional processes such as quality documents (eg, SOPs), templates, and other written guidelines; help to identify cross‑functional gaps and areas of improvement, and collaborate with key stakeholders and senior management within R&D to propose and implement solutions 

Required Qualifications

• Minimum of 10 years of Medical Writing or other relevant pharmaceutical/biotechnology industry experience; previous people management experience strongly preferred. Advanced degree/academic research or other transferrable skills may be considered in lieu of industry experience
• Successful leadership of Medical Writing deliverables for complex submissions to health authorities, such as marketing applications
• Deep knowledge of health authority requirements, ICH guidelines, and submission-ready standards of relevance to document authoring, including eCTD and submission lifecycle management
• Strong experience with identifying and interpreting information/data for inclusion in documents authored by Medical Writing such as clinical trial protocols, investigator’s brochures, clinical study reports, briefing documents, and clinical overviews/summaries for marketing applications
• Involvement with ex-US submissions for clinical trial applications and marketing applications
• Ability to multitask assigned or delegated activities and prioritize in accordance with corporate strategic objectives
• Proficiency in project planning tools such as MS Project, collaborative authoring, document review tools, and Veeva RIM Suite
• Expertise in Microsoft Word (including use of customized toolbars/templates) and use of document management systems
• Excellent communication skills, organizational skills, and attention to detail

Desired Qualifications

• Recent neuroscience experience (within 2 years)
• Experience contributing to outsourcing strategies and vendor selection, including resourcing/budgeting forecasts for assigned projects
• Awareness of clinical trial disclosure requirements including transparency/redaction
• Familiarity with relationships between Quality and Nonclinical content and documents prepared by Medical Writing

Education

• Academic degree (BA/BS at minimum) in a relevant scientific or healthcare discipline, advanced degree (eg PhD) in scientific or healthcare field preferred