responsible for a broad range of legal, regulatory and compliance issues affecting the pharmaceutical and biotech industry
provide expert legal support to Marketing, Sales, Medical Affairs, Patient Relations, Regulatory Affairs and Corporate Compliance
assist with, and at times manage, areas of legal responsibility that become relevant through the commercial lifecycle of the Company's various products
provide guidance to Sales, Marketing, Medical Affairs, Patient Relations, Regulatory and Corporate Compliance departments related to the Food Drug and Cosmetic Act, the False Claims Act, Anti-Kickback Statute, the Sunshine Act and other healthcare related laws and regulations
serve as a Legal representative on the Company's promotional review committee, including review of promotional and sales training materials
provide legal support for the Company’s Patient Relations function
assist with reviewing, drafting and/or revising compliance related policies and standard operating procedures
assist with privileged compliance audits and investigations
provide guidance to the Company’s Compliance Committee
manage outside counsel on compliance and regulatory matters
perform all other related duties as assigned

Juris Doctorate (JD) from an accredited law school
10+ years of experience as an attorney
8+ years of experience in healthcare and FDA law
4+ years of experience as in-house counsel at a pharmaceutical or biotech company
Solid command of relevant legal subject matter with the ability to manage collateral areas of legal responsibility that become relevant through the lifecycle of the Company's various products
Effective communicator and collaborative team member
Strong written communication and drafting skills
Mac/PC and MS Office proficient
Ability to work in a fast-paced, dynamic environment

Director, Senior Counsel – Regulatory & Compliance

Key skills