Senior Medical Director

(NYC) Senior Medical Director – Healthcare communications firm seeks a Senior Medical Director with a focus on regulatory communications. This position requires a motivated and detail-oriented scientist with outstanding communications skills. Will join a team of experts in preparing pharmaceutical, biotech, and device company clients for successful regulatory submissions and health authority meetings.

Requirements
• Current, hands-on experience in the preparation of critical regulatory documents and presentations
• Experience working in a consulting or agency environment collaborating with multiple clients in diverse therapeutic areas
• Experience preparing for EMA Oral Explanations and/or FDA Advisory Committee meetings, and developing Target Product Profiles/regulatory strategy is preferred
• In-depth knowledge and understanding of regulatory/compliance guidelines, submission requirements, and best practices
• Team player able to collaborate with a team of medical writers and editors, project managers, and strategic consultants to service clients in a project-based environment
• Willingness to travel up to 25%, including occasional weekend travel

Qualifications
• Advanced degree in the life sciences
• No less than 5 years of experience in the development of critical regulatory and clinical documents and/or regulatory affairs

Salary: Competitive |  Job#: JR-4485