Sr Ethics amp Compliance Officer REMOTE

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PURPOSE AND SCOPE:The Senior Ethics & Compliance Officer (SECO) will manage the compliance program for several product lines within the renal pharmaceutical and medical device divisions of Fresenius Medical Care North America (FMCNA). The SECO will be supervised and mentored by the VP, Compliance and, ideally, will be viewed as a successor to that role.  Responsibilities generally include a mix of managing compliance procedures and internal controls, leading larger-scale projects to completion, and advising business partners on complex legal and ethical issues (described in greater detail below). The SECO will need to be adept at issue-spotting, balancing multiple, competing factors, and offering practical risk-based guidance on significant matters, as well as comfortable frequently exercising independent judgment; accordingly, the successful candidate is expected to have 6-12 years of experience managing a pharmaceutical, medical device, or life sciences compliance program.PRINCIPAL DUTIES AND RESPONSIBILITIES:Acts as an accessible, visible and available subject matter expert for the business.Establishes a compliance culture as a strategic, competitive advantage.Maintains current knowledge of law, regulation, and market changes that impact all aspects of the business including, but not limited to, Anti-Kickback Statute, FDA rules, Health Insurance Portability and Accountability Act, relevant Office of Inspector General (OIG) Model Guidance and applicable Advisory Opinions, AdvaMed Code, and PhRMA Code.Adeptly identifies gaps and inefficiencies in compliance systems and processes. Proposes proportionate remediation measures.Identifies key risk areas and works with the business to mitigate risk through education, training, policy development and monitoring systems.Responsible for developing, implementing and maintaining relevant compliance training materials, including introductory training for new employees as well as ongoing training as required. Delivers compliance training presentations as necessary, live or via MS Teams.Provides guidance to the business in the development and interpretation of policies and procedures.Participates in the development of the annual FMCNA compliance plan.Directs or participates in - collaborating with other departments as applicable - the timely closure of Compliance Action Line (CAL) investigations along with other potential compliance issues not reported through the CAL. Responds appropriately to alleged violations of rules, regulations, policies, procedures, and the FMCNA Code of Conduct.Participates in various committees and task forces on a Corporate, divisional and cross-divisional basis, and coordinates and manages compliance projects as required.Assists with recurring Compliance meetings, ensuring high level compliance issues are addressed. May be required to provide presentations on new initiatives, to report on the results of case management, or to schedule speakers.Other duties as assigned, including department wide projects.PHYSICAL DEMANDS AND WORKING CONDITIONS:Work is performed predominantly in an office or home office environment and requires the ability to operate standard office equipment and keyboards. Some periods of time may be spent standing in training rooms and operating presentation devices.The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Travel is expected to be up to 20% of overall work time.EDUCATION:Bachelor's degree required.Law, MBA or advanced Degree preferred.Professional certification such as State Bar Membership, CHC, CIPP or CHPC is a plus.EXPERIENCE AND REQUIRED SKILLS:6-12 years of experience managing a pharmaceutical, medical device, or life sciences compliance program.Strong writing skills with specific experience in the areas of developing, implementing and maintaining policies, procedures and training in a healthcare environment.Strong communication, interpersonal and presentation skills, working with both internal and external individuals and entities.Ability to motivate, lead and coordinate cross-functional teams of senior management personnel.Analytic and project management, leadership and team building.Strong computer skills, including Excel, Word, and PowerPoint.EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.,identifier:R0085843,industry:Headquarters,title:Sr Ethics & Compliance Officer (REMOTE),url:****

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