Counsel/Senior Counsel for Healthcare Compliance
Overview: We are currently seeking a qualified, highly motivated, experienced legal professional with pharmaceutical industry experience for the position of Counsel/Senior 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 and level will be commensurate with the experience of identified candidate.
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 approval of promotional materials for Coherus products and product candidates.
Participate on review committees with respect to medical publications, MSL materials, grants, sponsorships, speakers programs, consultant and advisory board meetings, grand rounds, CME and similar activities involving communications with healthcare entities.
Support the operations of the Compliance Committee and prepare Board briefings.
Provide training to Coherus personnel and vendors, including field sales personnel.
Advance and further refine, and support implementation and education on, Company’s existing 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.
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.
Assess Healthcare Compliance training needs for Coherus businesses in light of external developments and risk areas and assist the Coherus Healthcare Compliance functions with the development and delivery of content to meet these needs.
Assist with investigations relating to potential violations of policies, standards or procedures or other Healthcare Compliance issues in all areas, including but not limited to fraud and abuse, product promotion and other regulatory matters and government price reporting.
Assist with auditing and monitoring activities related to Coherus’ businesses and help ensure compliance with applicable reporting requirements.
Review and negotiate commercial agreements, including marketing, distribution and other related agreements.
J.D. degree from an accredited law school required.
Licensed to practice law in a US state or DC.
10-15 years of relevant experience in a law firm and/or corporate legal department; in-house corporate legal experience preferred.
Ability to work independently and to communicate legal issues and solutions clearly and concisely.
Excellent interpersonal, verbal and written communication skills.
Ability to appropriately assess legal risk and develop good working relationships with clients to facilitate teamwork and achievement of mutual goals across organizational boundaries.
Leadership skills in updating and advising Company stakeholders on changes in regulations, policies, enforcement which may impact the Company’s activities.
Demonstrated success working in a high-performing, results-driven environment.
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