End-to-end bespoke solutions that de-risk & accelerate our partners' and sponsors' drug and device development programs
Legal Promotional Review Consultant
Location
United States
Posted
3 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Legal Promotional Review Consultant
ProPharma
Role Description 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. Qualifications - A degree is required, focus in Medical, Science, Marketing, Business or Communications; an advanced degree and JD is strongly preferred. 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. Benefits - Contract opportunity. - Fully remote working.
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