Job Title: Senior Director, Medical Writing

Work Location: REMOTE-EAST COAST

Summary:

The Senior Director, Medical Writing is responsible for leading the delivery of high-quality clinical and regulatory documents across all investigational and marketed products. This role involves collaborating with stakeholders, managing external vendors, and potentially building an internal team to ensure efficient and compliant medical writing services. The Senior Director will play a key role in process development, cross-functional collaboration, and ensuring the accuracy and consistency of all documentation throughout the drug development lifecycle.

Responsibilities:

• Oversee long-term project forecasting and resource planning to ensure timely delivery of required clinical and regulatory documents.
• Manage the selection, contracting, and ongoing operations of external vendors, including resource forecasting and financial oversight.
• Independently author and supervise the creation of submission-ready clinical and regulatory documents, ensuring clarity and compliance.
• Develop and implement processes, initiatives, and tools to enhance operations and maintain compliance with regulatory standards and guidelines.
• Serve as a subject matter expert, advising cross-functional teams on document strategy, authoring, review processes, and best practices.
• Coordinate and lead multiple rounds of document review, consolidating feedback and ensuring high-quality finalization of documents.
• Collaborate with data sciences and regulatory operations to ensure documents meet data reporting needs and eSubmission standards.
• Lead the preparation and public disclosure of study results on national registries, ensuring compliance with relevant regulations and internal procedures.

Qualifications:

• BA/BS degree and 12+ years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred.
• Demonstrated success in managing internal, external, or hybrid resources.
• Direct experience leading medical writing teams responsible for global marketing authorization applications.
• Experience with a broad range of clinical regulatory documents throughout the drug development lifecycle.
• Strong understanding of drug development processes, regulatory requirements, and ICH/GCP/eCTD guidelines.
• Working knowledge of clinical research, study design, biostatistics, regulatory, and medical terminology.
• Excellent technical writing, editorial, and attention to detail skills.
• Strong ability to interpret and present medical and scientific data.
• Proficiency in Microsoft Word, PowerPoint, Excel, Project, SharePoint, and experience with automated document templates, Adobe Acrobat, and EndNote.
• Excellent communication, interpersonal, and organizational skills; experience working on cross-functional teams.
• Ability to prioritize tasks, manage multiple projects simultaneously, and deliver high-quality documents under tight timelines.

Published Category: Medical Writing