Health Care Compliance Manager Job in Menlo Park, California US
Acclarent, Inc. a member of the Johnson Johnson's Family of Companies, and Micrus Endovascular LLC., a wholly owned subsidiary of Codman and Shurtleff, Inc., a Johnson and Johnson Company, are recruiting for a Manager of Health Care Compliance located in Menlo Park, CA in the new independent centralized global Health Care Compliance organization.
The description below is specific to the position at Acclarent:
The Manager of Health Care Compliance (HCC) is primarily responsible for the implementation of programs designed to ensure the Company meets statutory and regulatory requirements relating to health care fraud and abuse; as well as advertising and promotion laws governing the company's commercial and scientific activities. This key position assures the alignment of the company's HCC activities within the overall organization and reinforces the message that compliance is a company priority and has access to the resources needed to assure implementation of an effective compliance program.
A key component is also to build partnerships with all levels of Management and employees at the Company and also with HCC Professionals within HCC Organization to support consistency of decision making and approach to risk mitigation. The manager will regularly work with the HCCO in review the HCC Program and make appropriate revisions and modifications.
The individual will also advise and engage with Commercial Leadership, including Sales, Marketing and Operations as well as RD, Clinical and Regulatory providing sustained HCC support. The individual also may advise Senior Management at the Company and the HCCO and periodically Sector VP of HCC of potential compliance risk areas and recommends and implements appropriate action plans. At the direction of the HCCO, the manager will coordinate support and resources with the HCC Global Operations Group to ensure ongoing effectiveness of the HCC program; in particular for the creation and implementation of appropriate HCC Training, Testing Monitoring, and Tracking/Database Management. The individual is also responsible for implementing internal controls so that they are capable of preventing and detecting significant issues or patterns of fraud and abuse. The role may also support HCC investigations in concert with the Sector Investigations Lead and the JJ Law Department and ensures appropriate and consistent application of HCC related disciplinary action.
Principal relationships within the Company include: engagement with Commercial Operations (Sales, Marketing, Ops, etc), Medical/Clinical Affairs, Prof Education Groups, representation of HCC on the Company Management Board (US) as required, managing contact with all levels of employees across the Vision Care Franchise on HCC related matters, and coordination with the Global Operations team and Regulatory Attorney(s).
Additionally and more specifically, the individual will:
Serve as the primary point of contact for Health Care Compliance (HCC) policies and procedures within the Sales, Marketing, and Medical/Clinical Affairs areas of the organization:
Develop partnerships with management teams to reinforce compliance principles and embrace ownership to make compliant decisions
Advise internal stakeholders of potential compliance risk areas and develop and manage risk mitigation plans
Conduct testing and monitoring
Support financial disclosures under federal and state laws, as well as voluntary disclosures
Effectively influence individuals at the highest levels of the organizations supported.
Responsible for providing HCC direction, guidance, support, and oversight for day to day business activities:
Program concepts related materials
Totality approvals for all transactions regarding value exchanges with customers
Analyzing trends from Oversight Monitoring activities and taking action as necessary (eg., training, investigation, policy revisions/updates)
Review and provide input into business strategies, tactics, incentive compensation plans and call plans
Recommend and develop additional monitoring plans for high risk projects
Identify training needs, develop deliver appropriate Compliance trainings for internal and external business partners
Participation on cross-functional and/or cross-company teams may include:
Charitable contributions
Educational Grant committee
CPC committee
Identified HCC task forces
The description below is specific to the position at Micrus Endovascular:
The Manager of HCC will also support some HCC activities for Micrus Endovascular, LLC. ("Micrus"). Micrus Endovascular is located in San Jose, CA. The individual will be responsible for some specific HCC activities at Micrus Endovascular and include the following: data gathering for reporting HCC metrics, creating work instructions, managing an expense monitoring plan for Codman/ Micrus internal associates and independent sales representatives, following up on any corrective actions resulting from Codman/ Micrus HCC audits, delivering of HCC training to Micrus personnel, and managing other HCC projects as required.
Qualifications
BA or BS required. Masters in related field, advanced degree desirable. Requires at least 7 years of business experience including management and supervisory responsibilities. 3 plus years experience and demonstrated leadership in HCC is required. Exceptional written and verbal communications skills essential, as well as, a proven track record of sustaining compliance in complex organizations is required. Demonstrated experience in the development and implementation of a compliance surveillance program in accordance with the organization's risk profile is preferred. Requires knowledge and the ability to apply HCC/fraud and abuse laws (AKS, FCA, FCPA); FDA regulatory promotional practices; financial or auditing practices (TM) and company business and policies. Pricing and government contracting knowledge; sales and marketing management and Scientific Affairs and work with external Trade Associations experience a plus. Experience with FDA advertising and promotional practices regulations - including DTC - for medical devices or pharmaceutical products, commercial aspects of marketing medical devices or pharmaceutical products, sales, financial, marketing or related business functions is preferred.
Experience creating and implementing policy. Experience with development of appropriate compliance systems. HCC experience in a non-pharmaceutical field may be appropriate. Experience with overseeing the development and presentation of appropriate employee education and training programs including formal training and periodic education-related communications
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