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Manager / Senior Manager, Compliance Counsel, Global Compliance and Ethics
Refer job# WGPC136805
 
Manager / Senior Manager, Compliance Counsel, Global Compliance and Ethics The candidate will assist the Associate Director, Global Compliance and Ethics in analyzing and addressing risk by developing, implementing, updating, monitoring, and enforcing the compliance policies, initiatives, and processes of company and its subsidiaries' as part of the Global Compliance Program (GCP). Will develop expertise in the legal and compliance risk areas facing rare-disease biopharmaceutical companies (e.g., advertising & promotion, fraud and abuse, anti-kickback, privacy, GXP, and false claims act statutes). Support the development, implementation, and maintenance of GCP activities, including counseling and training on compliance policies, anti-bribery/anti-corruption laws, healthcare compliance regulations, privacy, and transparency/aggregate spend regulatory requirements. Draft memoranda providing legal analysis and risk-based recommendations regarding the compliance rules and regulations (e.g., advertising and promotion, fraud and abuse, anti-kickback, privacy, and false claims act statutes) implicated by proposed or existing business strategies. Counsel internal brand teams 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. Assist with coordination and management of healthcare auditing and monitoring program, as well as development and maintenance of GCP recordkeeping and metrics tracking systems. Develop familiarity with broader organization to identify, analyze, and mitigate risk. Assist with investigation of alleged violations of compliance policies, laws, regulations, or procedures. Develop and implement corrective action plans where compliance violations have been established. Assist with the review and analysis of advertising and promotional initiatives, pipeline products/clinical trial recruitment materials, grants/donations and sponsorships, government price reporting and related research on FDA/OIG enforcement activities. Assist with creation of training plan and training modules in connection with compliance policies, including but not limited to: new hire orientation, anti-bribery and anti-corruption program, privacy, and promotional regulations. Present trainings to business units as needed. Prepare monthly briefing documents to keep Executive Management up-to-date on latest industry events and trends including OIG and FDA enforcement statistics, CIA trends, global enforcement trends, and analysis of OPRP/DDMAC warning and untitled letters. Work with internal functional areas to provide advice and counsel, ensure 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 GCP related activities and requirements, including management and coordination of outside consultants.

The candidate should have a Bachelor's degree and J.D. degree. Must have 2-4 years of experience practicing law or working in the pharmaceutical/healthcare compliance field. Experience in-house, at a regulatory agency, or at a major law firm strongly preferred. Should have experience with, or eagerness to become expert in, compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry. Experience with, or eagerness to develop knowledge and understanding of, the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines is needed. Should have experience with, or eagerness to develop knowledge and understanding of, the legal and regulatory framework affecting the pharmaceutical/biotechnology industry including: 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. Must be willing to travel, including internationally, as necessary.
 
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