About Us

About the job

At Biogen, we are pioneers in neuroscience. The role of Senior Manager/Associate Director of Regulatory Advertising and Promotion requires the ability to provide regulatory strategic advice on global and U.S. communications for promotional materials and medical/scientific materials for healthcare providers, payors and patients in support of Biogen business objectives. This individual will effectively partner and collaborate with cross-functional stakeholders and ensure that materials are competitive and compliant with applicable FDA regulations, PhRMA guidelines, and Biogen policies.

Responsibilities

  • Provide regulatory strategic input, risk assessment, and mitigation strategies to various global and U.S. internal teams on branded and unbranded concepts, promotional materials, disease awareness communications, medical communications and sales training/education materials
  • Provide creative and solution-oriented feedback to meet business goals and further business objectives
  • Provide strategic advice for the development of Advisory Comments submissions
  • Ensure promotional materials are consistent with FDA-approved labeling, compliant with applicable FDA regulations, and completed in accordance with 2253 submissions requirements
  • Develop and maintain strong working relationships with internal colleagues including, but not limited to: Commercial, Medical, Legal, Compliance, Regulatory Strategy, and Medical/Marketing Operations
  • Work with management and Reg AP team members to ensure communications and feedback are generally consistent across therapeutic areas
  • Assist Regulatory Ad Promo department in monitoring evolving regulatory landscape and communicating updates to internal stakeholders

Requirements

  • BS required; advanced degree preferred
  • Minimum of 3-5 years of Regulatory promotional review
  • Detail and deadline oriented; well organized
  • Capabiltity to analyze and assess risk and then effectively communicate across interdisciplinary teams
  • Ability to dissect and interpret complex disease information and product efficacy/safety data
  • Demonstrates strong negotiation and interpersonal skills to influence others and build team collaboration, consensus and partnerships
  • Adapts to dynamic environment and business needs
  • Ability to develop and maintain relationships with OPDP
  • Excellent verbal, written, and presentation skills