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Biogen Director, Regulatory Affairs Advertising and Promotion - Alzheimer's in Weston, Massachusetts

A. Essential Functions:

• Actively contribute to the development and implementation of regulatory strategy for promotional labeling and other communications including social media, press releases and talking points for Alzheimer's

• Regulatory lead on the Promotional Review Committee for Alzheimer's

• Coordinate all aspects of AP regulatory submissions including promotional materials and pre-use submissions for subpart E&H products as needed

• Provide regulatory representation to early stage programs, including review of DSMR materials as needed

• Prepare and deliver effective presentations for external and internal audiences.

• Represent Regulatory Ad-Promo on global regulatory teams

• Supervise and mentor direct reports if applicable

• Participate in industry groups

• Comment on draft guidance’s issued by FDA

• Represent Ad-Promo on cross-functional teams

• Actively contribute to the development and implementation of regulatory training programs for cross-functional partners

B. Additional Functions:

• Contribute to organizational effectiveness.

• Maintains optimism and energy in the face of change and adversity.

• Effectively serve as a role model within regulatory and cross-functionally.

• Ability to impact industry and agency organizations.

• Ability to step in for Sr. Director as needed.

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• Minimum 8+ years pharmaceutical/Biotechnology industry experience, 6+ years regulatory advertising and promotion experience, Alzheimer's and/or Neurology experience preferred.

• Ability to work both independently with minimal direction and within teams to attain group goals.

• Demonstrate excellent communication skills.• Demonstrate effective cross-cultural awareness and capabilities.

• Demonstrate strong organizational skills, including the ability to prioritize workload.

• Strong interpersonal skills and the ability to deal effectively with a variety of staff including commercial, medical, scientific, and clinical development staff.

• Knowledge and understanding of applicable regulations.

• Experience in interpretation of regulations, guidelines, policy statement related to product labeling, promotions and other communications.

• Direct experience with regulatory agencies

• Computer literate.

• Sensitivity for a multicultural/multinational environment

• Global Advertising and Promotion experience, a plus

The role is located in Weston, MA and reports into the Sr. Director Advertising and Promotion. Your 6+ years of experience in Ad/Promo will be an asset to our critical work being done in our Alzheimer's group.

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