For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
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.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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