Executive Director of Legal Affairs, Chief Compliance Officer and Associate General Counsel
The Executive Director of Legal Affairs, Chief Compliance Officer and Associate General Counsel will have primary responsibility for the design, implementation, oversight, and enforcement of the Company’s compliance programs and will report directly to the General Counsel and SVP of Legal Affairs, with a dotted line to the CEO.
The Executive Director of Legal Affairs, Chief Compliance Officer and Associate General Counsel will advise and support the Company’s Commercial Operations, Clinical, Regulatory, Manufacturing and Development functions to ensure compliance with all applicable Federal and state laws, rules and regulations. Specific responsibilities will include, but not be limited, to the following:
- Provide advice and counsel on a day-to-day basis with respect to all laws, rules and regulations governing the commercial sale of pharmaceuticals, clinical and pre-clinical research and development and manufacturing.
- Design, implement, monitor and enforce Company-wide compliance program to ensure conformity with all applicable U.S. and foreign laws, rules and regulations, including but not limited to all rules and regulations of the FDA, OIG, and CMS, and all applicable anti-kickback, privacy, fraud and abuse, anti-bribery and product liability statutes.
- Provide advice and counsel on Federal and state laws and regulations regarding the reporting of payments to healthcare professionals and organizations (e.g. federal Sunshine) and ensure timely generation and submission of Federal and reports.
- Provide counsel and leadership on various matters, including corporate governance, compliance, contractual, litigation, risk management and a variety of other legal and business issues.
- Develop necessary internal review processes, compliance metrics, monitoring programs and internal auditing processes.
- Advise and assist the Company’s Compliance Committee.
- Train sales force and other employees with respect to applicable Federal and state laws, rules and regulations.
- Review advertising, marketing, promotional and training materials and programs to ensure compliance with applicable laws, rules and regulations.
- Assist with the review and negotiation of commercial agreements, including clinical trial, marketing, distribution, and other commercial agreements to ensure compliance with all Federal and state laws, rules and regulations.
- Provide legal oversight of corporate grants program.
- Provide legal advice and counsel with respect to government price reporting obligations and serve as member of government price reporting team.
- Minimum of 8 to 10 years of relevant experience in the biotech/pharmaceuticals industry and/or equivalent law firm experience.
- Experience supporting Commercial Operations function, preferably for a commercial stage pharmaceuticals, biopharmaceutical or biotechnology company.
- Deep knowledge of FDA, OIG, CMS and FCPA rules and regulations, including issues regarding commercial contracting, pharmaceutical labeling, product promotion, managed care, government contracting, price reporting and product liability.
- Strong communication, administrative and time management skills.
- Excellent business judgment and strategic thinking.
- Team player with ability to form strong working relationships with clients while maintaining firm adherence to proper legal standards.
- Flexibility and willingness to work on a broad variety of legal matters.
- JD and admission to Massachusetts bar strongly preferred.