Minimum Requirements/ Qualifications
- 5 to 10+ years as a practicing attorney in the field of healthcare compliance; prior in-house and law firm experience preferred.
- Extensive expertise with compliance matters relating to the development, approval and commercialization of biotechnology or pharmaceutical products, privacy, and FDA issues, with an understand of the OIG Guidance, applicable laws and regulations relating to the development, advertising, promotion, sales and marketing of pharmaceutical products and the current federal and state enforcement landscape.
- Experience developing and implementing effective compliance policies and programs.
- Comprehensive knowledge of U.S. healthcare fraud and abuse laws, FDA, OIG, FCPA, and CMS regulations, rules and guidances, pharmaceutical marketing, price reporting, privacy, federal and state disclosure requirements.
- Experience in drafting and negotiating a range of agreements relating to research, clinical, and commercial activities relevant to a biotechnology or pharmaceutical company.
- JD degree from an accredited law school.
- Current member in good standing of a U.S. state bar (Massachusetts preferred).
Other Skills and Abilities
- Strong written and oral communications skills required to work both internally and externally.
- Ability to meet deadlines while managing a substantial workload in a fast-paced environment.
- Ability to recognize risk and develop workable strategies to mitigate such risk.
- Ability to engender confidence when advising clients at all levels.
- Ability to work with little oversight.
- Ability to work with the highest level of integrity is essential.
- Excellent business judgment and strategic thinking.
- Flexibility and willingness to work on a broad variety of legal matters.
- Ability to travel (approximately 10%) as required.
LEADERSHIP SKILLS and CHARACTERISTICS THAT SPEAK TO WHAT WE VALUE
· Understands that gene therapy is transformational and paradigm-breaking, and remains comfortable when facing uncertainty and new terrain. Possesses the ability to pivot readily and reshape to evolving business needs while remaining focused on doing the right thing, modeling ethical behavior. Possesses sound business judgment and strategic thinking, with the ability to influence others without serving as the authoritative figure.
· Can solve even the toughest and most complex of problems. Great at recognizing risk and developing workable strategies to mitigate such risk. Flexible and willing to work on a broad variety of legal and compliance matters. Respectful and comfortable working through conflict; knows that crises happen, deals promptly and fairly through critical points.
· Attacks everything with drive and energy, meeting deadlines while managing a substantial workload in a fast-paced environment; drives to finish everything he/she starts. Maneuvers well to get things done; politically aware and agile; knows what the right thing to do is. Works easily with little oversight. Works with the highest level of integrity.
· Is skilled at getting individuals, teams, and an entire organization to perform at a higher level of compliance. Communicates clearly in writing and orally developing a compelling vision of what excellence looks like and is committed to what needs to be done; inspires others.
· Is open and receptive to working in teams at all levels within the organization. At ease and relaxed; easy to talk to and get to know; listens attentively; engenders confidence when advising clients at all levels and deals calmly with stress.