Compliance Specialist Ethics and Compliance

Job Description

Job Description:

• The Compliance Specialist, Ethics & Compliance, under the direction of the Ethics and Compliance Manager and in support of the Chief Compliance Officer, will play a critical compliance role working closely with the Medical and Scientific Affairs team and other client functional areas.
• The Compliance Specialist will provide guidance and compliance process support on complex issues and serve as the primary Ethics and Compliance resource for the Medical and Scientific Affairs team.
• The Compliance Specialist uses deep subject matter expertise in FDA, OIG and AdvaMed Code compliance, regulations, and best practices coupled with a clinical background to provide meaningful guidance to Medical and Scientific Affairs and other client functional areas.

• Maintains a deep understanding of global and local Ethics and Compliance policies and procedures, and serves as the primary Ethics and Compliance (E&C) resource to Medical and Scientific Affairs (MSA) function.
• Serves as an ad hoc member of MSAs Integrated Medical Teams (currently 6 IMTs), enabling speed to impact for client Diagnostics Corporation (RDC) squad and IMT priority outcomes.
• Maintains awareness of MSA vision, priorities and evidence generation landscape in order to facilitate execution of priority medical outputs grounded in a focus on compliance.
• Leverages understanding of and works in support of the OIG-HHS seven elements of an effective compliance program, and the AdvaMed Code.
• Directly ensures the incorporation of compliance by design, in the development and continuous improvement of MSA policies/procedures, enabling efficient and effective MSA operations.
• Serves as the primary advisor, reviewer and E&C contact for all MSA outputs requiring E&C review/approval, including contracts with external stakeholders, HCP logistics and travel, Investigator Initiated Studies (IIS)/ client Sponsored Studies (RSS)contracting, applications lab studies/activities, study reagent delivery, sponsorship/grant processing, educational programming, advisory boards, technical publications operations and MSA publications.
• Ensures appropriate documentation alignment, standardization, and effectiveness of compliance activities.
• Leads and manages compliance risk management/mitigation strategies and plans.
• Provides Ethics and Compliance guidance to other internal cross-functional groups.
• Contributes to the ongoing development, enhancement and streamlining of compliance methodologies and practices (including standard operating procedures (SOPs) and other policies/procedures).
• Trains and educates others on internal and external compliance requirements to assure ongoing high-performance and compliant operations.
• Establishes and cultivates cross-functional relationships and works collaboratively with all internal/external partners and stakeholders.
• Provides up-to-date information on current legal, compliance and client policy requirements that build awareness of the program, processes, and potential legal ramifications of noncompliance.
• Provides insights regarding regulatory changes, trends, areas for potential risk, and process gaps, and offers compliance guidance and reporting to senior management and governance boards.
• Escalates Compliance issues to the Ethics and Compliance Manager and/or Chief Compliance Officer when appropriate.
• Other duties as appropriate may be assigned by Ethics & Compliance department leadership.
• Provide subject matter expertise on compliance and risk management issues and topics to Medical and Scientific Affairs and how they interact with the business and external HCPs and HCOs.
• Stay current with industry trends, any relevant laws, and legal or regulatory decisions related to healthcare compliance.
• Analyze Compliance risk, Client areas of potential compliance risk and vulnerability, and create and implement solutions to eliminate the potential risks.
• Collaborate with other legal, regulatory affairs, and compliance professionals cross-functionally to ensure regulatory and contractual requirements are met.
• Act as a liaison between MSA stakeholders and Ethics and Compliance to ensure effective mitigation of risk.
• Demonstrate independence and high competence in establishing, shaping, and leading medical compliance risk and opportunities across client Diagnostics Corporation.
• Assign, track and monitor training compliance needs, generate training reports, and communicate training requirements and training completion status to stakeholders.
• Bachelors degree (science or health care, or legal, preferred) and 5 years professional diagnostics, medical device or pharmaceutical industry experience, including 2+ years previous MSA, healthcare compliance, or clinical experience.
• Demonstrated understanding of medical and scientific affairs including governing regulations, best practices, and engagement requirements.
• Excellent written and verbal communication skills, presentation skills, gravitas, and organizational/project management skills.
• Stellar communication and interpersonal skills.
• Strong attention to detail.
• Demonstrated ability to manage complex operational processes and projects.
• Demonstrated ability to effectively synthesize and communicate findings in a structured, thoughtful manner.
• Strategic thinking skills to provide practical advice with an awareness of legal risks in the business context.

• Experience interpreting relevant healthcare compliance laws and regulations specifically in the medical and scientific space to appropriately apply to work tasks.
• Familiarity with compliance oversight of medical and scientific activities.
• A seasoned professional with a positive can-do attitude, flexibility and adaptability, wide-ranging experience, business acumen, professionalism and sound judgment.
• A team player who collaborates well and proactively with others, who seeks to understand first in order to deliver the needed solution or guidance.
• A demonstrated ability to establish and maintain open, candid and trusting work relationships.
• Ability to exercise independent judgment, and to work with and maintain confidential and sensitive information.
• Excellent analytical and problem solving skills and the ability to manage ambiguous situations and issues.
• Enthusiasm and self-starter qualities, and ability to manage responsibilities with an appropriate sense of urgency.
• Ability to function effectively and efficiently in a fast-paced and dynamic environment.
• CHC or equivalent certification preferred.