Intra-Cellular Therapies
Manager of Compliance
Intra-Cellular Therapies, Bedminster, New Jersey, us, 07921
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.
The Manager of Compliance will report to the Executive Director in Compliance and will help support the Compliance team on the management and continuous improvement of all Seven Elements of an effective Compliance Program, including Aggregate Spend reporting, to comply with Federal and State regulatory 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:
Support the Compliance team in maintaining an effective Compliance Program including:
Policies:
Assist in updating and creating policies and procedures relating to interactions and promotion with healthcare providers
Maintain Compliance website and other compliance resource platforms
Training and Education:
Assist in managing the Compliance Department’s training plan and objectives including identifying target audience, training methods, and timelines for effective training delivery
Deliver live new hire Compliance training and other training as needed
Partner with Sales Training, LMS Training Department, and external vendors to ensure appropriate and effective training and education across the organization
Compliance Monitoring and Auditing
Support compliance monitoring and auditing activities including follow up with employees on all policy violations and track violations in the Compliance case management system
Experience analyzing data for potential compliance issues from various sources, such as T&E records, speaker program data, and Open Payment data to detect anomalies, patterns, and outliers that may indicate non-compliance or potential risks
Investigations and Corrective Action:
Assist with 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.
Maintain Company’s Whistleblower line and Compliance case management system
Aggregate Spend Reporting
Assist with reconciliation and reporting of Sunshine and State HCP reporting as needed
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.
Requirements:
College Degree required from an accredited college or university
Up to 5 years of compliance experience within the pharmaceutical or life sciences industry
Knowledge of the legal and regulatory environment within the pharmaceutical or life sciences industry
Experience working with vendors and consultants and keep each accountable to task and budget on specific projects
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
Must complete all company and job-related training as assigned within the required timelines
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.
Manager of Compliance - Base Salary Range $110,000 - $130,000
#ITCI
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.
The Manager of Compliance will report to the Executive Director in Compliance and will help support the Compliance team on the management and continuous improvement of all Seven Elements of an effective Compliance Program, including Aggregate Spend reporting, to comply with Federal and State regulatory 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:
Support the Compliance team in maintaining an effective Compliance Program including:
Policies:
Assist in updating and creating policies and procedures relating to interactions and promotion with healthcare providers
Maintain Compliance website and other compliance resource platforms
Training and Education:
Assist in managing the Compliance Department’s training plan and objectives including identifying target audience, training methods, and timelines for effective training delivery
Deliver live new hire Compliance training and other training as needed
Partner with Sales Training, LMS Training Department, and external vendors to ensure appropriate and effective training and education across the organization
Compliance Monitoring and Auditing
Support compliance monitoring and auditing activities including follow up with employees on all policy violations and track violations in the Compliance case management system
Experience analyzing data for potential compliance issues from various sources, such as T&E records, speaker program data, and Open Payment data to detect anomalies, patterns, and outliers that may indicate non-compliance or potential risks
Investigations and Corrective Action:
Assist with 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.
Maintain Company’s Whistleblower line and Compliance case management system
Aggregate Spend Reporting
Assist with reconciliation and reporting of Sunshine and State HCP reporting as needed
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.
Requirements:
College Degree required from an accredited college or university
Up to 5 years of compliance experience within the pharmaceutical or life sciences industry
Knowledge of the legal and regulatory environment within the pharmaceutical or life sciences industry
Experience working with vendors and consultants and keep each accountable to task and budget on specific projects
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
Must complete all company and job-related training as assigned within the required timelines
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.
Manager of Compliance - Base Salary Range $110,000 - $130,000
#ITCI