Our biopharmaceutical client here in MA is growing and looking to add a Sr. Director, Legal & Compliance to their team! Reporting to the VP, Chief Compliance Officer and Senior Counsel, role will provide legal counsel in areas specific to risk management in healthcare (e.g., AKS, FCA, PDMA, FDAMA, Sunshine Act, privacy, promotion and advertising, and patient assistance programs) and support the implementation and maintenance of a robust and effective corporate compliance program. The successful candidate will have demonstrated experience in supporting in-house legal and compliance efforts, strong technical, organizational, and interpersonal skills and have a team-first attitude. The position will plan and lead the implementation of a variety of activities throughout the year to raise awareness of the importance of relevant legal concepts and compliance efforts. This will include facilitating an ethical culture, assisting with the development and implementation of legal and compliance training and communications, and interacting with business colleagues at all levels of the organization to issue spot and positively impact decision making with risk management awareness. This position will also have day-to-day administrative tasks and team administrative work. The ideal candidate will have strong attention to detail, is an effective communicator and is always a team player, eager to jump in where needed and collaborate with others to support the goals of the company.
- Advise and educate internal clients on key legal risks, corporate compliance and other risk management issues relevant to a biopharmaceutical company. Experience with early-stage pipeline development and pre-commercialization issues is a plus.
- Support legal and compliance efforts, including the development and ongoing review of policies and procedures and the implementation of training initiatives.
- Build and support the culture of the legal and compliance department as a valued business partner, by working collaboratively with key stakeholders (including senior management, internal clients, intellectual property, and Finance), gaining a deep understanding of the business and its needs, and implementing a pragmatic approach consistent with those needs.
- Foster a strong internal compliance, ethics, and “speak-up” culture.
- Manage a hotline system. Experience conducting investigations and preparing written investigative reports is a plus.
- Manage third party screening and other risk management programs.
- Advise and support corporate activities inherent in a life science company, e.g., filing state and federal reports (open payments, government price reporting, etc.), reviewing corporate materials, and evaluating interactions with Healthcare Professionals and other key stakeholders.
- Represent the Legal and Compliance Team on cross-functional initiatives and collaborating with other members of the Legal and Compliance Team on internal initiatives.
- Other responsibilities in support of the Legal and Compliance team, functional, and/or corporate strategies and goals.
- Juris Doctorate (J.D.) from an ABA-accredited law school; be an attorney in good standing with license to practice in the state where you reside; and have the ability to obtain MA in-house counsel registration
- Have a minimum of 5 years of relevant experience. This includes knowledge and experience in advising on healthcare law topics (e.g., AKS, FCA, FCPA, GDPR, PDMA, FDAMA, Sunshine Act, privacy, promotion and advertising, and patient assistance programs).
- Ability to analyze complex legal concepts, communicate the implications in clear and simple language, and recommend appropriate courses of action.
- Have experience drafting and negotiating standard agreements used in the pharmaceutical industry. Having an understanding of the laws and practices applicable to the research and development of pharmaceutical products is a plus.
- Have experience developing content and implementing a training program for company-wide awareness of legal, compliance and ethics concepts and policies through an LMS or other electronic methods.
- Have experience in managing a hotline database and responding to legal and compliance related inquiries. This may include responding timely to incidents and inquiries received, documenting the work and actions taken in a central database, and tracking investigations and inquiries.
- Ability to contribute to discussions of general business issues, to work well with a wide range of clients, from senior executives to operating personnel, and to work independently as well as to lead a project from conception to completion.
- General understanding of technology commonly used to support a corporate compliance program.
- Ability to periodically travel.