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Sr. Manager, Compliance

Employer
Intra-Cellular Therapies, Inc.
Location
Bedminster, NJ
Start date
Aug 4, 2024
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Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country
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Job Details

 

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 Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. Currently celebrating our 22nd anniversary, we have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.


This role will report directly to the Executive Director, Compliance with a dotted line to the Director, Transparency and Monitoring. The Sr. Manager will be responsible for developing, implementing, and maintaining various aspects of the Compliance Program including training, policy, monitoring, auditing, HCP engagements, communications, investigations, and corrective action. The Sr. Manager will also focus on partnership with home office and field stakeholders in support of Business and Compliance functions. This is a hybrid position with expectation of attendance in the office twice a week.


Responsibilities 

  • Develop, update, and implement compliance policies and procedures, including Code of Conduct. 
  • Training, Education and Communications: Lead the Compliance training, education, and communications program. Develop, implement, and execute all aspects of compliance training program including new hire onboarding training. Partner with Sales Training and the LMS Training Department to ensure appropriate and effective training and education across the organization. Responsible for Compliance communications including the development of content, newsletters, and maintain the Compliance website.
  • Investigations: Manage internal compliance investigations and coordinate appropriate follow up actions as needed. Enforce compliance standards in partnership with key stakeholders including HR and legal. Manage the Compliance Departments Whistleblower Line and follow up.
  • Monitoring and Auditing: Implement effective auditing and monitoring programs and processes to ensure effectiveness of overall compliance programs; inclusive of policies and procedures, trainings, investigations, and other compliance initiatives. Manage the Compliance Department’s Incident Management Tool and all follow up.
  • Risk Management: Support all risk mitigation and enhancement processes and plans. Develop risk assessment protocols for ongoing review.
  • HCP Engagements:        Oversee ITCI’s HCP Engagement and FMV process. Partner with Finance and Legal to ensure appropriate contracting and finance controls are also met with respect to HCP engagements.
  • Project Management: Identify and lead strategic projects designed to fulfill the needs of and enhance the effectiveness of the ITCI Compliance Program. Drive results-oriented process improvement.
  • Other Duties: Assist the Compliance Team and CCO with the preparation of reports, summaries, and documentation for internal and/or external use and other duties as assigned.

    • Requirements

  • Bachelor’s degree required from an accredited college or university.
  • Minimum 5-7+ years of compliance, monitoring, auditing, project management and other relevant experience within the pharmaceutical or life sciences industry.
  • Working knowledge of the legal and regulatory environment within the pharmaceutical or life sciences industry.
  • Ability to successful work with team and partner with internal cross-functional teams.
  • Strong analytical, organizational, problem-solving, and follow up skills required.
    • Ability to communicate effectively with individuals at all levels, internally and externally.
  • Proactive, self-starter with a strong sense of ownership and accountability.
  • Keen attention to detail.
  • Demonstrated proficiency with Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.
  • Hands on experience supporting a learning management system.
  • Complete all company and job-related training as assigned within the required timelines
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice
  • 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.

    Sr. Manager, Compliance: Base Salary Range $120,000 - $150,000

    #ITCI

    Company

    Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. Currently celebrating our 22nd anniversary, we have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.

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

    Company info
    Website
    Location
    430 E 29th St Ste 900
     New York
    New York
    10016
    US
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