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Food & Drug Administration Attorney / Government and Government Relations Attorney in Redwood City, CA

COHERUS BIOSCIENCE Nov 16,2018 Jun 01,2018 Location USA Redwood City CA
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In-House

Attorney

Government and Government Relations

Health Care

Litigation - Regulatory Enforcement (SEC, Telecom, Energy, etc.)

Min 2 yrs required

Profile

Compliance Counsel Candidate will: Provide healthcare compliance and FDA regulatory legal support and be responsible for Healthcare Compliance program implementation, training, communication, monitoring, auditing and enforcement activities. Manage the operation of Compliance Program, working under the direction of the Healthcare Compliance Officer. Provide advice with respect to rules and regulations governing the commercial launch and sale of products. Review and approve promotional materials for products and product candidates. Participate on review committees with respect to Medical Publications, MSL materials, Grants, Sponsorships and other payments to healthcare entities. Support the operations of the Compliance Committee and prepare Board briefings. Provide training to personnel and vendors, including field sales personnel. Further develop the Company’s Healthcare Compliance program to ensure compliance with all applicable rules and regulations, including those of the FDA, OIG and CMS, and all applicable anti-kickback, privacy, fraud and abuse and anti-bribery statutes; identify and close any gaps. Provide advice regarding the reporting of payments to healthcare professionals and organizations (e.g., Sunshine Act). Provide advice on fair market value (FMV), interactions with healthcare professionals and clinical trials compliance. Provide advice with respect to government pricing and reimbursement price reporting. Advise members of the Commercial team regarding how to implement business initiatives that are compliant with Healthcare Compliance policies and standards. Must be a qualified, highly motivated, experienced legal professional with pharmaceutical industry experience.

Company info