Sr Manager/ AD, Regulatory Affairs- Remote

Company: Biogen
Location: Salt Lake City
Posted on: January 15, 2022

Job Description:

Job Description

About This Role

At Biogen, we are pioneers in neuroscience. The role of Sr Manager/Associate Director of Regulatory Advertising and Promotion in Multiple Sclerosis requires the ability to apply regulatory strategic advice when evaluating promotional materials and medical/scientific communications for healthcare providers, payors and patients while also supporting 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.

• This is a remote opportunity*
  What You'll Do
  
  • Provide regulatory strategic input, risk assessment, and mitigation strategies to various internal teams on branded and unbranded concepts, promotional materials, disease awareness 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 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
    Ensure promotional materials are consistent with FDA-approved labeling and completed in accordance with Subpart E and 223 submissions requirements
    
    Who You Are
    
    Qualifications
    
    Positive individual who demonstrates integrity and agility while working in fast-paced and compliant environment to advance external HCP, payor, and patient initiatives. Consistently manages and prioritizes multiple and competing responsibilities for an expanding business that strives to meaningfully change the lives of people living with serious neurological diseases.
    
    Required Skills
    
    • 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
      Why Biogen?
      
      Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
      
      Additional Information
      
      All your information will be kept confidential according to EEO guidelines.

Keywords: Biogen, Salt Lake City , Sr Manager/ AD, Regulatory Affairs- Remote, Executive , Salt Lake City, Utah