Legal Promotional Review Consultant Job at ProPharma Group, Raleigh, NC

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  • ProPharma Group
  • Raleigh, NC

Job Description

Legal Promotional Review Consultant

Job Summary:

  • Leading in the management of the legal aspects of advertising and promotional review associated with drugs, biologics, combination products, OTC, Medical Devices, etc.
  • Providing strategic input necessary for deliverables and formal health authority interactions and communications
  • Acting as lead for legal review, guidance, and compliance during Promotional Review Committee (PRC) meetings

Essential Functions:

  • Review and approval of all promotional and non-promotional materials for assigned PRC with strong understanding of legal policy and advertising and promotion regulations and guidelines.
  • Attend prioritization discussions for the assigned PRC.
  • Contribute significantly to a high-quality work product, ensuring on time and within budget delivery.

Necessary Skills and Abilities:

  • Strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.
  • Proven ability to provide strategic direction and innovative, forward thinking legal affairs guidance and analyze and interpret efficacy and safety data.
  • Deep understanding of the advertising/creative development process.
  • Understanding of the pharmaceutical review and approval process for promotional materials across various regulatory environments.
  • Experience in leading activities necessary for the submission of promotional materials to relevant regulatory authorities.
  • Experience with using social media platforms for the promotion of prescription drugs in accordance with applicable local regulations.
  • Proficiency in computer applications and configuration, including Microsoft Office, Adobe Acrobat. Proficiency in Veeva Vault PromoMats or other electronic review platforms.

Educational Requirements:

  • A degree is required, focus in Medical, Science, Marketing, Business or Communications; an advanced degree and JD is strongly preferred.

Experience Requirements:

  • 5+ years of related experience in the pharmaceutical/ biotech industry is required. May consider related experience from healthcare advertising agency.
  • Functional experience in pharmaceutical industry regulatory/legal affairs is required.
  • Strong project management experience is required, in pharmaceutical industry is preferred.

Job Tags

Contract work, Local area, Remote job,

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