Director, Medical Writing

Role Summary

Reporting to the Vice President, Head of Regulatory, the Director, Medical Writing supports development teams and be primarily responsible for writing and overseeing various clinical and regulatory documents. This position interacts with other functions (e.g., clinical development, clinical operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs). This person works to ensure the documents are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The Director, Medical Writing leads efforts to author documents including protocols, Investigator’s Brochures, annual reports, clinical study reports, regulatory briefing documents, and clinical sections of regulatory submissions (IMPDs, INDs, and CTAs). Some authoring of nonclinical documents may be included.

Previous experience in authoring and reviewing clinical and regulatory documents is desired. The ability to lead strategic discussions to ensure aligned messaging throughout regulatory documentation is critical.  Outstanding communication skills are a must.

Primary Responsibilities Include:

• Write, edit, or collaborate with program team members on a variety of regulatory documents including protocols, investigator brochures, clinical study reports, INDs, and briefing books
• Ensure efficient document management as well as a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier
• Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards
• Oversee document review roundtables and comment adjudication meetings
• Contribute to overall project management and to cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
• Develop best practices for authoring and reviewing
• Manage external writing staff as directed

Education and Skill Requirements:

• Bachelors degree or high in Life Sciences, with a solid understanding of the basic principles of biochemistry and molecular biology
• At least 5 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required
• Demonstrates competence in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents per company and other guidelines
• Understands of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
• Demonstrates technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., SharePoint)
• Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to tight timelines
• Detailed knowledge of requirements for preparation of key clinical, nonclinical and regulatory documents for INDs, CTAs, and annual reports
• Accurate and detail-oriented
• Aptitude for compilation, analysis, and presentation of data
• Independently motivated, and good problem-solving ability
• Ability to work with multiple contributors to produce a final unified document

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