What are the responsibilities and job description for the Regulatory Review Manager position at Clinical Resource Network (CRN)?
As a regulatory review manager, you will provide critical oversight of promotional review committee meetings and ensure compliance with FDA regulations.
Key Responsibilities:
- Collaborate with cross-functional teams to develop and implement effective promotional strategies.
- Draft and negotiate complex contracts for distribution, managed care, and global R&D agreements.
- Act as legal representative at medical review committee meetings, reviewing responses to requests for information from healthcare professionals.
Qualifications:
- Juris Doctorate degree and licensure to practice law in New Jersey or eligibility for a limited certificate of admission.
- At least 10 years of experience in the life sciences industry, preferably in a legal capacity.
- Excellent knowledge of FDA regulations, government enforcement of prescription drug marketing integrity, and plaintiff tactics in failure-to-warn cases.
By joining CRN, you will become part of a dynamic team that provides clinical research and talent solutions to top pharmaceutical, biotech, and medical device companies.