Associate Director, Training, Monitoring, and Investigations at Intra-Cellular Therapies, Inc.

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

“We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders”

Intra-Cellular Therapies is a biopharmaceutical company committed to the development of novel CNS drugs, leveraging innovative technology based on the pioneering efforts of ITCI co-founder and Nobel laureate, Dr. Paul Greengard. ITCI has a diverse portfolio of approved and investigational compounds across different stages of clinical development. Our lead candidate, lumateperone (CAPLYTA®), is FDA-approved for the treatment of schizophrenia in adults as well as for the treatment of bipolar depression in adults as monotherapy and as adjunctive therapy.

The Associate Director of Compliance Training, Monitoring and Investigations will report to the Executive Director in Compliance and will be primarily responsible for all aspects of training, monitoring, auditing and Compliance investigations.  The Associate Director will collaborate with other members of the Compliance team on continuous improvement to all Seven Elements of an effective Compliance Program to comply with Federal and State requirements.

 This is a hybrid Headquarters based position.  There is an expectation that the candidate will be in the Bedminster office on Tuesday and Wednesday weekly.

Responsibilities:

• Oversee the implementation of the Compliance Department’s Training, Monitoring, Auditing and Investigations 

• Compliance Monitoring and Auditing:

  • Manage third-party monitor 
  • Develop and maintain annual monitoring plan
  • Conduct and oversee the monitoring of:
    • Speaker Programs
    • Meals with HCPs
    • Consulting and Ad Board arrangements with HCPs
    • Live Field Ride Alongs and Speaker Program observations
    • Email and other documentation review for compliance with policies and procedures
  • Provide oversight, direction, and collaboration of external compliance field monitors.
  • Identify trends and gaps for continuous improvement and discipline.
  • Conduct audits of third parties for compliance with speaker programs, consulting, advisory board policies and transparency requirements.
• Training and Education: responsible for developing and maintaining the Compliance training plan and training content. Develop, implement, and execute all aspects of the compliance training and design. Partner with Sales Training and the LMS Training Department to ensure appropriate and effective training and education across the organization.
• Investigations:  Conduct internal compliance investigations and collaborate with HR, outside counsel, and other internal stakeholders to coordinate investigations.  Participate in Outcome Committee meetings regarding employee coaching and discipline. Deliver Coaching and Discipline.
• The Associate Director will collaborate with other members of the Compliance team on continuous improvement to all Seven Elements of an effective Compliance Program to comply with Federal and State requirements.

Requirements:

College Degree required from an accredited college or university
• 8-12 years of compliance, training, monitoring, auditing, and investigations within the pharmaceutical or life sciences industry
• Knowledge of the legal and regulatory environment within the pharmaceutical or life sciences industry
• Working experience managing vendors and consultants and keep each accountable to task and budget
• Ability to successfully work and partner with internal cross-functional teams
• Strong verbal and written communication skills
• Understanding of LMS and training systems
• Ability to prioritize and work on multiple projects and strong attention to detail
• Must be able to perform all essential functions of the position, with or without reasonable accommodation

Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.

Associate Director, Compliance Training, Monitoring, and Investigations Base Salary Range $130,000 - $165,000

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