Executive Director, Medical Writing
About the Company
Emerging biopharmaceutical company
Industry
Biotechnology
Type
Public Company
Founded
1996
Employees
201-500
Categories
Specialties
About the Role
The Company is in search of an Executive Director for Medical Writing, a pivotal role that involves leading and managing the medical writing function to ensure the efficient preparation of high-quality, strategically aligned deliverables. The successful candidate will be responsible for overseeing a team of regulatory and medical writers, developing and implementing medical writing strategies, and providing leadership to ensure alignment with regulatory and business goals. This role requires a strong background in global regulatory requirements, extensive experience in writing regulatory submission documents, and the ability to build effective partnerships with cross-functional teams. The Executive Director will also be involved in strategic program planning, driving medical writing initiatives, and ensuring compliance with industry standards and best practices. Applicants for the Executive Director position at the company should hold a Bachelor's, Master's, or PhD in a scientific, medical, or clinical discipline, with at least 15 years of industry regulatory writing and clinical medical writing experience. A minimum of 12 years in a management role, preferably in the pharmaceutical or biopharmaceutical industry, is also required. The ideal candidate will have a strong understanding of global regulatory requirements, exceptional communication skills, and the ability to manage multiple priorities. Expertise in Microsoft Office and knowledge of document content preparation tools is essential. The role demands a leader with a proven track record in team management, strategic planning, and a commitment to the highest standards of quality and compliance in medical writing.
Hiring Manager Title
Senior Vice President, Regulatory Affairs
Travel Percent
Less than 10%
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