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Associate Director MD Open (J#45182)

Title: Associate Director
Company: MedImmune

Description

In conjunction with the Senior Director, Regulatory Affairs, this individual is responsible for the regulatory/scientific review, approval, and submission of advertising and promotional materials, including related content to include materials generated by sales training, corporate affairs, medical affairs, etc., as covered in relevant procedures. This person is a primary support role for the product-related content generated both in the commercial and medical affairs organizations. This role may also support Emerging Brands and the Corporate Review Process. Requirements

Position:
A minimum of 5 years experience in Regulatory Affairs or equivalent industry experience with emphasis on regulatory promotion and compliance preferred. Prefer at least 5 additional years experience in the Biopharmaceutical Industry. Knowledge of FDA regulations required. Regulatory experience with biological products and/or drugs required. Direct interaction with senior level management in previous roles preferred. Must demonstrate the ability to balance business needs with the changing regulatory environment. Strong people skills and attention to detail are strongly preferred.
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