Job Description
Title: Healthcare Compliance Consultant
Reports to: Chief Legal Officer
Location: Redwood City, California
Classification: Part-time Exempt
Overview:
Coherus Oncology, Inc., a commercial and clinical stage biotech company, is seeking a qualified, highly motivated, experienced healthcare compliance professional with pharmaceutical industry experience for a part-time role (20 hours per week) serving as a Healthcare Compliance Consultant. This role will provide healthcare compliance support and be responsible for healthcare compliance program implementation, including policy, training, communication, monitoring, auditing, transparency reporting, investigation, and enforcement activities. This position is based in Redwood City, CA, although remote candidates will also be considered.
Responsibilities:
Manage the operation of Coherus’ Healthcare Compliance Program, working under the direction of the Chief Legal Officer/Chief Compliance Officer.
Provide advice with respect to rules and regulations governing the development and commercialization of Coherus products.
Responsible for development and maintenance of healthcare compliance policies.
Participate on review committees with respect to Grants, Sponsorships, and other payments to healthcare entities.
Support the operations of the Healthcare Compliance Committee and prepare Board briefings.
Provide training to Coherus personnel and vendors, including field sales personnel.
Further develop and maintain 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.
Provide advice and complete filings regarding the annual reporting of payments to healthcare professionals and organizations to applicable jurisdictions (e.g., Federal Sunshine Act) .
Provide advice on fair market value (FMV), interactions with healthcare professionals and clinical trials compliance.
Potentially provide advice with respect to government pricing and reimbursement price reporting.
Advise members of the Coherus Commercial and Medical Affairs teams regarding healthcare compliance implementation of business initiatives.
Assess Healthcare Compliance training needs for Coherus’ businesses in light of external developments and identified risk areas, develop content to meet these needs and assist with training.
Potentially review and approve promotional materials for Coherus products and product candidates.
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.
Conduct auditing and monitoring activities related to Coherus’ businesses and help ensure compliance with applicable reporting requirements.
Provide healthcare compliance input with respect to commercial agreements, including marketing, distribution, data purchase, contract sales force and other related agreements.
Qualifications:
Detailed knowledge of core healthcare compliance laws, regulations and industry codes.
10-15 years of relevant experience in a law firm, corporate legal department with in-house healthcare compliance experience, and/or corporate healthcare compliance department.
Ability to work independently and to communicate healthcare compliance issues and solutions clearly and concisely.
Excellent interpersonal, verbal and written communication skills.
Ability to appropriately assess 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.
The Base Salary Range for this position is $200/hr to $350/hr. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.