Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

Senior Manager, Advertising, Promotion and Labeling

  • Location

    Boston

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Nikita Madan

  • Contact email:

    n.madan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    21 days ago

  • Expiry date:

    2020-07-15

  • Startdate:

    ASAP

  • Serve as Regulatory Reviewer on Commercial and Medical Review Boards for assigned product(s)
  • Provides regulatory guidance in the development and approval of compliant advertising and promotional materials.
  • Advise on clinical study design and labeling to support desired commercial claims
  • Act as lead at review metings by leading discussion  and collaborating with other reviewers to determine next steps and approval status.
  • Act as expert on FDA regulations governing the promotion of prescription pharmaceutical products.
  • Obtains understanding of OPDP requirements as well as undesratnding of enforcement trends.
  • Performs detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with FDA approved labeling and delivers consistent, well-supported, and clear guidance.

Requirements

  • BA/BS degree and 6+ years of relevant experience, including 2-4 years of experience in the regulatory review of promotional materials for prescription drug and/or biologic products.