Executive Director, Compliance Counsel

Coherus Biosciences Redwood City, CA
Overview: We are currently seeking a qualified, highly motivated, experienced legal professional with pharmaceutical industry experience for the position of Executive Director, Counsel for Healthcare Compliance. This role will provide healthcare compliance and FDA regulatory legal support and be responsible for Healthcare Compliance program implementation, training, communication, monitoring, auditing and enforcement activities. This position is based in Redwood City, CA.

Principal Responsibilities and Duties:

* Manage the operation of Coherus' Healthcare 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 Coherus products.

* Review and approve promotional materials for Coherus 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 Coherus 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 Coherus Commercial team regarding how to implement business initiatives that are compliant with Healthcare Compliance policies and standards.

Qualifications:

* J.D., Graduation from an accredited law school.

* Admission to a U.S. state bar (preferably CA) and active license to practice law required.

* 8-10 years of experience with a biotechnology or pharmaceutical company's legal department, or a law firm that has a nationally recognized FDA/life sciences practice.

* Experience as a commercial lawyer providing legal advice and support for FDA-approved marketed products or equivalent.