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Job Details

Director Regulatory Counsel

Experience
3 yrs required

Location
Cambridge, MA, United States

Posted on
Sep 16, 2020

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Profile

Director, Regulatory Counsel
Responsibilities: Provide legal support for the Sales, Marketing, Commercial Operations, Medical Affairs and Patient Advocacy functions, in the furtherance of their operational responsibilities and consistent with the requirements of the Company’s Healthcare Compliance Program. Participate in multifunctional committee reviews of promotional and medical materials and in oversight of commercialization activities. Builds high ethical standards in promotional practices in order to maintain credibility and trust with customers and to reduce significant enforcement, investigation, and reputational risks. Ongoing tracking and evaluation of legal and regulatory developments at the Federal and state levels pertinent to the commercialization of innovative pharmaceuticals, including but not limited to guidance and advisories from FDA, OIG, DOJ, and other relevant government agencies. Review contracts in support of the Commercial and Medical Affairs departments, including consulting agreements, speaker agreements, advisory board agreements, and certain vendor services agreements. In collaboration with the Healthcare Compliance function, and taking into consideration input from operational clients and colleagues, maintain and modify Company policies in a risk-based manner, as necessary to reflect changes and clarifications to applicable laws and regulations. Assist Healthcare Compliance and Data Privacy Compliance with developing standard contracts and policies and procedures. Handle miscellaneous legal tasks on an as needed basis under direction of senior attorneys.

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