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Senior Medical Director

at Medical Communication  |  Salary: Competitive |  Job#: JR-4481 |  15 Feb 2017

(New York City) Senior Medical Director – Medical communications company seeks a Senior Medical Director with a focus on regulatory communications. Requires a motivated and detail-oriented scientist with outstanding communications skills. Applicant 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
Good understanding of the clinical development process
Willingness to participate in new business development activities
Willingness to travel up to 25%, including occasional weekend travel

Qualifications

Advanced degree in the life sciences
Experience in the development of critical regulatory and clinical documents and/or regulatory affairs
Demonstrated track record of commitment to excellence in technical skills, client relations, problem solving, and collaboration with colleagues
Leadership skills and creative thinking


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