Opportunities • Frink-Hamlett

Opportunities

Associate Director, Compliance Operations (NJ).001

Job Title
Associate Director, Compliance Operations (NJ).001
Duration
Description

A global pharmaceutical company located in North NJ seeks an Associate Director, Compliance Operations who will be responsible for implementing monitoring and risk mitigation activities as identified in the annual risk assessment.  Base salary is up to $180K with a 16%-20% target bonus and LTI (additional cash).  

Primary Duties

The Associate Director, Compliance Operations will serve as the lead point-person for the Company's monitoring program in the U.S., including the management of in-house monitoring and engagement of third-party vendors. The person will also be responsible for supporting the department’s shift to data-driven mitigation and will be responsible for providing regular readouts of observations to support the Company's neurology and oncology commercial and medical business groups. Additional responsibilities include the following: 

  • Responsible for helping to propose solutions, research and vet potential vendor solutions, and project manage the implementation of new solutions
  • Live monitoring of speaker programs
  • Commercial and medical ride-alongs
  • Records reviews of commercial call logs
  • Review of responses to medical information requests
  • Records reviews of payments to HCPs to ensure company process are being followed
  • Support Ethics & Compliance oncology and neurology business partners in any investigations that stem from monitoring activities
  • Develop quarterly monitoring read-out reports for the neurology and oncology commercial and medical business groups on monitoring observations, trends, and corrective action plans
  • Manage third-party vendor relationships for identified monitoring activities
  • Responsible for managing the development, implementation, facilitation and evaluation of third-party vendors
  • Execute on implementation strategies for global monitoring initiatives
  • Liaise with the business on the development of a Commercial Operations group to support the monitoring of sample distribution
  • Identify trends based on monitoring activities that will help inform training needs
  • Presents in-person and online training sessions
  • Support departmental and cross-functional compliance projects 
  • Responsible for one direct report

Requirements

  • 8+ years of auditing and monitoring experience preferred
  • 5+ years of pharmaceutical/biotech industry experience with Compliance, Legal, or Medical equivalent experience
  • 2+ years of vendor management experience.
  • 2+ years of management experience
  • Bachelor’s degree required
  • Strong knowledge of key laws and regulations impacting the pharmaceutical industry including the PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Status; 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 in order to interface effectively with various cross-functional groups
  • Strong project management skills such as scheduling, planning, and prioritizing several diverse activities, initiatives, and projects from different individuals, groups, or departments
  • Must have demonstrated the development of new and creative solutions to a variety of challenging problems
  • Travel up to 20% of the time.
Frink-Hamlett Legal Solutions is an equal employment opportunity employer and all applicants will receive consideration for employment without unlawful discrimination based on race, color, creed, national origin, sex, age, disability, marital status, sexual orientation or citizenship status.
 

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