• Biogen Idec
  • $146,240.00 -146,240.00/year*
  • Weston , MA
  • Executive Management
  • Full-Time
  • 133 Wellesley St


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Job Description

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
* Regulatory lead on the Promotional Review Committee for assigned products
* 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 US 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* Comment on draft guidance's issued by FDA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 Director as needed.

Qualifications

* Minimum 6+ years pharmaceutical/Biotechnology industry experience, 4+ years regulatory advertising and promotion experience.
* 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 manufacturing 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

Education

BA/BS/University Degree required, Life/Health Sciences preferred. Graduate degree preferred.


Associated topics: cmo, community, donor, endowment, market, media, medical center, policies, product market, public

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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