Associate Director, Compliance

POSITION ID: ASSOCDIR 1321
CATEGORY:
PRACTICE AREA: ,
LOCATION: New Jersey
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The Associate Director, Compliance will report to the Senior Director, Corporate Ethics and Compliance, and assist with the implementation of the Corporate Ethics and Compliance Program for sales, marketing and other commercial functions as well as medical affairs and research and development. The position, in collaboration with the Senior Director, will develop and implement strategic compliance plans and recommend effective controls and processes for the covered functions to achieve compliance with the company’s policies and applicable laws, regulations and industry guidance.

Essential Functions:

  • Develop and deliver engaging, interactive and targeted training to clients to ensure that personnel are properly trained on compliance resources, risk areas, policies and procedures to minimize the risk of compliance and ethical violations; track the results of training efforts; and ensure appropriate follow-up for those who have not timely completed mandatory training.
  • Participate in the CECD monitoring program for covered functions and provide advice on and oversight of client activities in order to assess and detect risk areas and potential areas of concern; follow up on any items identified in monitoring and ensure that effective corrective action plans, training, policies, and procedures are in place to address risk areas identified.
  • Provide daily guidance to clients about policies, procedures, compliance risks, etc., to ensure that covered functions have an avenue to address questions, inquiries, issues, concerns and receive prompt guidance and support from the Corporate Ethics and Compliance Department.
  • Participate in and assist compliance investigations arising from employee complaints and instances of non-compliance; participate in committee, if necessary, that reviews investigations and recommended actions; ensure that potential violations of law and/or policy are addressed and appropriate remedies, corrective action and preventive measures result.
  • Draft and implement compliance policies, procedures, forms, and other tools to effectuate compliance program and proactively address risk areas.
  • Provide general support for department and enterprise-wide initiatives as needed.

    Requirements

  • Bachelor’s degree is required, advanced degree (e.g. J.D. is preferred);
  • Minimum of 8-10 years experience in legal or compliance function;
  • Must have prior experience with pharmaceutical manufacturer, biotech, medical device or healthcare organization, or in representing these organizations;
  • Must have proficient knowledge of laws, regulations, industry guidance and best practices regarding healthcare compliance activities;
  • Must have prior experience in the implementation of policies and training;
  • Must possess strong communication skills (oral, written) and be comfortable delivering presentations and training;
  • Prior experience in investigations and monitoring of pharmaceutical activities is a plus;
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