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Vice President, Chief Compliance Officer

Bridgewater, NJ, USA | Technology-Based Specialty Pharmaceutical Company

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
  • Experience:
    12-15 years
Job Description:
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Description:

The VP, Chief Compliance Officer oversees the Corporate and Healthcare Compliance Programs, functioning as an independent and objective entity that reviews, evaluates, mitigates and audits compliance issues/concerns within the organization. Reporting to the Sr. VP, Chief Legal Officer (with a dotted line to the CEO), the position ensures that appropriate compliance measures and controls such as policies, procedures, training, monitoring and auditing are in place to align with and support the requirements of industry laws, rules, regulations and guidance. The position is also responsible for communicating with and advising the Board of Directors, management and employees as needed to help ensure compliance with all applicable laws, rules and regulations that govern the company's business.




Essential Functions:

Establishing, maintaining and leading an effective compliance program and department in accordance with federal, state and industry regulations.

Act as independent review and evaluation body to ensure compliance issues/concerns with the company are being appropriately evaluated, investigated, and resolved.

Assessing and reporting on the current state of compliance of the company, identify potential areas of compliance vulnerability and risk, provide guidance and advice on compliance issues and mitigation of compliance risks.

Collaborate with other departments to ensure compliance issues are identified, evaluated and addressed. Liaise with counsel and other consulting resources as necessary to help ensure the company maintains an effective compliance program.

Prepare and submit federal and state reports regarding company's healthcare compliance and marketing activities in a timely manner


Qualifications

 

Education:

Bachelors Degree (BA/BS) four year college degree - Required

Master Degree (MS/MA) Advanced degree (such as JD or MBA) or healthcare specialty - Preferred

Experience:

Significant experience (12 years or more) with a deep understanding of compliance issues confronting the pharmaceutical/biotech industry.

1 to 5 years served in a compliance leadership role and demonstrated experience in building a compliance program.

15 years of managing people or a functional area

Skills:

Excellent written, oral and presentation skills. - Advanced

Demonstrated ability to work with effectively and collaboratively with all levels of management; strong influencing skills and sound business judgement. - Advanced

Strong problem solving skills and ability to operate successfully in a cmplex, constantly changing, fast-paced environment. - Advanced

Demonstrated initiative, proactive approaches, ability to manage a diverse and demanding workload and appropriately prioritize issues. - Advanced

Communication—Listening and Speaking: Listening • Receive, attend to, interpret, understand, and respond to verbal messages and other cues • Apply active listening skills using reflection, restatement, questioning, and clarification • Pick out important information in verbal messages • Understand complex instructions Speaking/Presenting • Speak clearly and confidently using common English conventions including proper grammar, tone, and pace • Express information to individuals or groups taking into account the audience and the nature of the information (e.g., explain technical concepts to non-technical audiences) • Present ideas in a persuasive manner - Advanced

Critical and Analytical Thinking: Using logic, reasoning, and analysis to address problems. • Use interdisciplinary skills to integrate knowledge of various academic disciplines to solve problems • Use logic and reasoning to identify strengths and weaknesses of alternative solutions, conclusions, or approaches to problems • Use inductive and deductive reasoning to analyze, synthesize, compare, and interpret information • Draw conclusions from relevant or missing information • Understand the underlying relationship among facts and connections between issues • Organize problems into manageable parts - Advanced

Specialized Knowledge:

Demonstrated knowledge and understanding of the required elements of a compliance program as outlined in the US Federal Sentencing Guidelines, the Anti-Kickback Statutue, the False Claims Act, FDA rules and regulations, OIG and other industry guidance, and other issues affecting the development, sales and marketing of pharmaceutical products


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