What are the responsibilities and job description for the Sr Manager Promotional Review & Clinical Contracts position at Mediabistro?
A NJ based Pharmaceutical company is looking for a consultant to join their team. The Consultant will bring legal expertise to the company's clinical and commercial stage programs. The ideal candidate will reside in NJ and willing to come onsite 2-3x a week.
ResponsibilitiesPromotional Review & Regulatory Review : Act as the legal representative at all Promotional Review Committee meetings. Apply FDA and Company guidance to items and work collaboratively with the Regulatory and Medical reviewers, as well as the initiators and PRC coordinators, to ensure legal compliance and ethics of our promotional campaigns and tactics.Contract Development & Negotiation : Drafting and negotiating contracts ranging from pre-clinical to clinical and a full range of distribution, managed care, and global R&D agreements. Refine and organize contract templates, standardized provisions, and guidance.Act as Legal Rep at Medical Review Committee meetings, reviewing responses to requests for information arising from HCPs, and other medical communications such as publications of studies.Work with Human Resources on employment matters, including agreements and investigations.Required Qualifications :
Juris DoctorateMust be licensed and in good standing to practice law in the State of New Jersey or eligible for a limited certificate of admission to practice in New Jersey.10 years of experience within the life sciences industry within legalIn-depth knowledge of (a) FDA regulation, (b) government enforcement of prescription drug marketing integrity, and (c) plaintiff tactics in failure-to-warn, qui tam, and employment cases.Promotional Review experience and Contract development and negotiation experience (clinical, R&D, Managed Care rebate and patient support)Expert in Microsoft Office, Adobe Professional, Veeva, OpenSource, and SharePoint.Experience identifying, creating, and implementing novel approaches to mitigate risk.Commitment to ethical conduct; manage confidential and proprietary information using excellent discretion and judgment.
If you meet the required qualifications and are interested in this role, please apply today.
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