Note: The job is a remote job and is open to candidates in USA. ProPharma is a consulting firm that has been enhancing health and wellness for over 25 years, offering expertise to biotech, med device, and pharmaceutical organizations. They are seeking a Legal Promotional Review Consultant to manage the legal aspects of advertising and promotional reviews, ensuring compliance and strategic guidance throughout the process.
Responsibilities
- 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
- 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
Skills
- A degree is required, focus in Medical, Science, Marketing, Business or Communications
- 5+ years of related experience in the pharmaceutical/ biotech industry is required
- Functional experience in pharmaceutical industry regulatory/legal affairs is required
- Strong project management experience is required
- 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
- An advanced degree and JD is strongly preferred
- Strong project management experience is preferred, in pharmaceutical industry
Benefits
- Fully remote working
- 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.
- Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration.
- As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager.
Company Overview
Company H1B Sponsorship