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.
  
  

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