Opportunities • Frink-Hamlett

Opportunities

Associate Director - Compliance

Job Title
Associate Director - Compliance
Duration
Location
North NJ,  NJ 07677
Other Location
Description

Associate Director - Compliance 

A global pharmaceutical company located in Northern New Jersey seeks an Associate Director - Compliance for a long-term, temporary position.  Compensation is competitive, depending on your experience.

Primary Duties

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 firm's policies and applicable laws, regulations and industry guidance.  

Key Roles and Responsibilities:

  • Provide guidance regarding policies, procedures, compliance risks 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
  • Draft and implement compliance policies, procedures, forms, and other tools to effectuate compliance program and proactively address risk areas
  • Participate in the company's 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
  • Develop and deliver engaging, interactive and targeted training 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 and assist compliance investigations arising from employee complaints and instances of non-compliance; participate in committee that reviews investigations and recommends actions; ensure that potential violations of law and/or policy are addressed and appropriate remedies, corrective action and preventive measures result
  • Provide general support for department and enterprise-wide initiatives as needed, including executing against the departmental work plan

Requirements

  • Bachelor’s degree is required, advanced degree (JD 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
  • Strong knowledge of key laws and regulations impacting the pharmaceutical industry including the PhRMA Code; Federal Food, Drug, Cosmetic Act (FDA); Anti-Kickback Statute; False Claims Act, OIG/DOJ Guidance; Foreign Corrupt Practices Act; and federal and state transparency and disclosure laws
  • Strong Excel and PowerPoint skills required; experience with Veeva and other CRM systems preferred
  • Excellent written and verbal communication skills, including the ability to translate data into actionable business process improvements
  • Strong interpersonal and collaboration skills for effective interface with various cross-functional groups

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