What are the responsibilities and job description for the Sr Manager Promotional Review position at Clinical Resource Network (CRN)?
Job Title: Clinical Consultant
A pharmaceutical company based in New Jersey is seeking a clinical consultant to join their team. The ideal candidate will bring legal expertise to the company's clinical and commercial stage programs, residing in New Jersey and willing to come onsite 2-3 times a week.
Responsibilities:
- Promotional Review & Regulatory Review: Act as the legal representative at all Promotional Review Committee meetings, applying FDA and company guidance to items while collaborating with regulatory and medical reviewers to ensure legal compliance and ethics of promotional campaigns and tactics.
- Contract Development & Negotiation: Drafting and negotiating contracts ranging from pre-clinical to clinical and global R&D agreements, refining and organizing contract templates and standardized provisions.
- Act as Legal Rep at Medical Review Committee meetings, reviewing responses to requests for information arising from healthcare professionals and other medical communications.
- Work with Human Resources on employment matters, including agreements and investigations.
Required Qualifications:
- Juris Doctorate degree
- Must be licensed and in good standing to practice law in the State of New Jersey or eligible for a limited certificate of admission
- 10 years of experience within the life sciences industry in legal roles
- In-depth knowledge of FDA regulation, government enforcement, and plaintiff tactics in failure-to-warn cases
- Promotional Review experience and Contract development and negotiation experience (clinical, R&D, Managed Care rebate and patient support)
- Expertise in Microsoft Office, Adobe Professional, Veeva, OpenSource, and SharePoint
- Experience identifying and implementing novel risk mitigation approaches
- Commitment to ethical conduct and managing confidential information
Clinical Resource Network Distinction:
CRN offers a comprehensive benefits program, including medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, setting us apart in the industries we serve.
About CRN:
Founded in 2002, Clinical Resource Network provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies, focused on forming long-term relationships through contract staffing, project staffing, consultative services, and full-time placements.
