Position Title: Associate/Deputy General Counsel for Healthcare*
(*Exact title will depend on seniority of individual hired for the position)
Department: Legal and Intellectual Property
Reports to: General Counsel & Head of Public Policy
Position summary: Serve as in-house counsel managing legal advice and services with respect to legal, policy, and regulatory healthcare matters affecting the biotechnology industry, primarily the regulatory activities of the FDA, CMS, and NIH, and related legislative activities.
1. Evaluate legal aspects of existing or proposed legislation, regulations, and guidance documents issued by relevant state, federal, and international entities for their impact on the biotechnology industry’s research, development, manufacture, distribution, and sale of biopharmaceutical products
2. Work with other BIO staff and Member companies to develop coordinated advocacy responses and/or comments with respect to such matters, including engaging in direct advocacy before federal and state legislative and/or regulatory bodies as requested.
3. Assess legal developments related to voluntary, industry self-regulatory efforts and initiatives, including bioethical matters, and work with BIO staff and Member companies to address such developments in a proactive manner.
4. Serve as Counsel to BIO’s Health Section Governing Board (HSGB), and the HSGB Committee on Regulatory Affairs, HSGB Committee on Reimbursement, and the HSGB Vaccine Policy Working Group; the ECS Governing Board, and its Committee on Health & Regulatory Affairs; the Full Board Committee on Bioethics; and all related staff-level committees.
5. Direct the activities of the Biopharmaceutical Law Committee, including development of BIO comments and responses to legal, regulatory, and policy developments of a legal nature. Assist with activities of the BIO General Counsels Committee in regard to healthcare issues, including with respect to amicus or other litigation matters on behalf of the industry.
6. Manage the efficient use of outside counsel within all of the above subject matter areas.
7. Assist with other legal activities of the Organization, as requested by the General Counsel.
A successful applicant will need to have extensive knowledge of FDA and, to a lesser extent, CMS regulations as they affect biotechnology and/or pharmaceutical manufacturers, and a sound understanding of the processes through which legislative and regulatory bodies act and through which interested stakeholders seek to influence such actions.
Other skills required include –
* the ability to work efficiently under tight deadlines
* the ability to communicate effectively and accurately with other BIO staff, Member companies, Board members, and regulatory agency personnel
* the ability to build consensus and foster compromise among often competing interests
Education and Experience Required:
An excellent academic record, with a J.D. degree and five or more years of legal work experience in Federal regulatory affairs (preferably FDA). There is a strong preference for candidates who have worked for or with biotechnology or pharmaceutical companies in these areas, or have worked within FDA in a legal capacity. Trade association experience in a legal or policy capacity is also a significant plus.