Description:

Who we are:
It takes a village, and at An American Biotechnology Company our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at An American Biotechnology Company.

Role and Responsibilities:

General Compliance Program Support

Support the development, implementation, and maintenance of the Global Corporate Compliance activities focusing on developing, updating and counseling on U.S. compliance policies, anti-bribery / anti-corruption laws, and healthcare compliance regulations as well as conducting internal compliance investigations.
Support of US Corporate Compliance regulatory intelligence efforts, including application of new and existing FDA and OIG guidance documents, emerging state and federal regulations, and industry codes (e.g. PhRMA) to current policies as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations.
Draft memoranda providing legal analysis and risk-based recommendations regarding the compliance rules and regulations (e.g., fraud & abuse, advertising and promotion, anti-kickback, and false claims act statutes) implicated by proposed or existing business strategies.
Counsel internal stakeholders regarding the aforementioned compliance rules and regulations, FDA and OIG guidance documents, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations.
Work with internal functional areas to develop and deploy appropriate/adequate training, and support adherence to policies/procedures relating to compliance matters.
Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.
Coordinate project management of various Corporate Compliance related activities and requirements, including management and coordination of outside consultants.

Internal Investigations Support

Provide support to Sr. Director, Compliance Counsel on all Internal Investigations of alleged violations of compliance policies, laws, regulations, or procedures.
Develop and implement corrective action plans where compliance violations have been established and track completion of corrective action activities.
Support and participate in Internal Investigations Governance Committee.
Support management of all records and executive read-outs related to Internal Investigations.

Education:
A bachelor's degree and JD are required as well as admittance to and good standing with a state bar.

Experience:

4-6 years of experience working in the pharmaceutical/healthcare legal/compliance/internal audit field. Experience in-house, at a regulatory agency, or at a major law firm also welcome.
Experience with and/or understanding of compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry generally.
Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, FDA regulations on the promotion of marketed products, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.
Demonstrated effectiveness operating in complex organizational and regulatory environments.
Excellent written, oral, and presentation skills.
Proven ability to work with all levels of management and the general workforce, a strong sense of professionalism, and the drive to provide superb and timely support to internal clients.
Strong problem solving, risk analysis, and project management skills.
Demonstrated ability to partner effectively with others in addressing complex issues.
Strong problem solving, risk analysis, and project management skills.