Director, Medical Writing

Role Summary

The Director, Medical Writing will collaborate with colleagues to write and/or oversee the development of 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.

Responsibilities

• Provide Medical Writing leadership in strategic project teams as the medical writing subject matter expert, including advising such teams on content, format, and style requirements for documents
• Manage in-house medical writing staff, vendors and contractors, providing guidance on prioritization, content, timeline development, and process management
• Mentor and support direct reports in the development of their skills and careers
• 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, and other regulatory submissions as needed
• Collaborate with document authors, contributors, and reviewers to deliver on clinical documents, including effective communication to manage expectations, resolve issues, and ensure alignment on document timelines and content
• Lead 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
• Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines
• Perform miscellaneous job-related duties and additional duties and responsibilities as needed

Qualifications

• 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

Education

• BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
• 10+ years (Director) of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience managing a team and writing clinical study protocols, clinical study reports, investigator’s brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents
• Knowledge of endocrinology, oncology, neurology and/or metabolic disease areas preferred