What are the responsibilities and job description for the Medical Regulatory Affairs Specialist position at ProPharma Group?
At ProPharma Group, we are dedicated to 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), we partner with our 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, we offer an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
The Role
- Providing compliant, medically accurate and scientifically sound solutions - while providing marketing with competitive solutions for consumer, healthcare provider and managed care promotional and non-promotional materials.
- Review of independent scientific/medical clinical materials for product launch, growth brand and established brand and derivative materials for assigned projects.
- Acting as lead for medical role during promotional review committee (PRC) meetings and overseeing the medical advertising promotional review process.
- Providing guidance on the Medical/scientific support for PRC and if need be, elevating the risk to their manager/line manager within the client.
This position is responsible for delivering detailed review of promotional, disease awareness and medical only materials for scientific and medical accuracy. The successful candidate will participate in cross functional team meetings and prioritization of discussions for the assigned promotional review team.
We require a strong project management experience in pharmaceutical industry and a deep understanding of scientific data from clinical trials, review articles, medical textbooks, etc. and how this data supports claims made consistent with the Anvisa approved label.
In addition, we seek a working knowledge of Anvisa and Pharmaceutical regulatory and compliance guidelines on advertising and promotion. Proficiency in computer applications and configuration, including MS Office, Adobe Acrobat, Veeva Vault, Promo Mats or other electronic review platforms is also required.
Necessary Skills and Abilities
- A 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 medical guidance and analyze and interpret efficacy and safety data.
- Working knowledge of Anvisa and Pharmaceutical regulatory and compliance guidelines on advertising and promotion.
- Deep understanding scientific data from clinical trials, review articles, medical textbooks, etc. and how this data supports claims made consistent with the Anvisa approved label.
Required Education and Experience
- A Bachelor's degree is required, focus in Medical, Science, Marketing, Business or Communications; a PharmD is preferred.
- 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 medical affairs is required.
