Healthcare Compliance Consultant
Coherus BioSciences, Inc.
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. Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Coherus Oncology’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability. A \"recently separated veteran\" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention‑deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. Are you legally authorized to work in the U.S? If you are hired by Coherus, you will be required to furnish documentation within three business days to show that you are legally entitled to work in the U.S. * Are you subject to any type of agreement with a current or former employer or entity that would restrict your ability to work at Coherus BioSciences (e.g., non‑compete, non‑solicitation)? * #J-18808-Ljbffr Coherus BioSciences, Inc.
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