Overview of Role:

The Director, Medical Writing will collaborate with colleagues to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.

Role and Responsibilities:

• Prepare, edit, and finalize clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed
• Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
• Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
• 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
• Participate in the development/refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides to ensure efficient preparation of high- quality medical writing deliverables
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
• Minimum of 10+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience 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 oncology disease areas preferred

• 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
• Excellent attention to detail, multitasking, prioritization, and flexibility
• Excellent communication skills with proven ability to interact in a cross-functional environment
• 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, Adobe Acrobat, electronic document management systems, and templates.
• 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 direction
• Ability to think strategically, be resourceful, and lead with minimal direction