Associate General Counsel, Commercial and Regulatory Affairs

US-MA-Watertown
1 month ago(11/15/2017 1:39 PM)
Job ID
2017-1082
# of Openings
1
Category
Legal

Overview

The Associate General Counsel is the lead commercial and regulatory attorney providing business focused strategic counsel on a broad array of commercial related matters in support of the Company’s product portfolio and pre-launch initiatives including product labeling, promotional review, compliance, FDA pharmaceutical regulations and requirements, advertising, and educational programs. This position will report to the SVP and General Counsel and will work collaboratively with outside counsel while working cross-functionally with the leadership team.  This position will have significant opportunity to expand his / her legal base within our rapidly growing business.

 

Responsibilities

  • Serve as the lead attorney and strategic advisor to a variety of internal teams on FDA regulations, Sunshine Act compliance, Anti-Kickback Statue, False Claims Act and PhRMA Code in connection with product labeling, promotional activities, marketing strategies, sales training and compensation, speaker bureaus, and communications with FDA and other regulatory agencies related to pending FDA approval
  • Advise and consult with all levels of the organization including senior leadership to identify critical legal issues, assess potential legal options, and provide individuals and teams with an analysis and range of possible legal solutions
  • Partner with the commercial and regulatory organizations to ensure adherence to compliance programs while providing guidance and training on the Code of Conduct and compliance policies and procedures
  • Partner with teams to establish a rapport and a positive working relationship, particularly within the corporate office and field medical affairs and field commercial team, to encourage and continue engagement of legal counsel in the achievement of objectives and goals
  • Review, analyze and advise on reimbursement activities, access services, patient support and assistance programs
  • Draft, review and negotiate commercial contracts, third party vendor agreements, service agreements, consulting agreements and other corporate agreements related to commercial and compliance matters
  • Uses technical expertise to support team and departmental projects

Qualifications

  • 10+ years legal experience with at least 5 years of experience advising in the pharmaceutical/ biotech industry
  • Significant legal experience and knowledge base in fraud and abuse counseling and FDA issues, with a working understanding of the OIG’s Guidance for the Pharmaceutical Industry, applicable regulations and laws relating to the development and marketing of pharmaceutical products, the enforcement landscape from a U.S. Department of Justice, FDA and State perspective
  • Preferred experience working at a leading U.S. national law firm in conjunction with an in-house counsel position with a leading biotech/pharmaceutical company with marketed products
  • Expertise in counseling clients on best practices for Commercial and Regulatory functions
  • Broad knowledge of the laws and regulations affecting the pharmaceutical industry, including the Food Drug and Cosmetic Act, Anti-Kickback Statute, Sunshine Act and False Claims Act
  • Excellent negotiation skills requiring effective interpersonal communication and oral and written communication skills
  • Ability to provide legal counsel to a wide variety of internal teams on legal and regulatory matters and interact effectively with employees at all levels of the organization.
  • JD from an accredited law school
  • Licensed to practice law in the United States and currently admitted to practice and in good standing as a lawyer in state(s) of admission.

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