Manager, Compliance Programs - United States
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- Our company is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders.
- We believe life is too beautiful to be interrupted by brain disorders.
- So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities.
- We strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease.
- For us, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do.
- Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at our company.
- Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them.
- The Manager, Compliance Programs will report to the Chief Compliance Officer (CCO), and will have direct responsibility for elements of or will assist in the implementation of elements of a compliance program modeled after the seven elements of a successful compliance program.
- The Manager, Compliance Programs will be directly responsible for assigning, tracking, maintenance, and reporting on training regarding policies and procedures for our company North America. This responsibility will include:
- maintaining (and updating) compliance training programs, directives, policies, and procedures;
- coordinating the development of new policies and procedures;
- coordinating with business units across the organization to determine compliance training requirements for employees in the business units;
- coordinating data collection to ensure that local and Corporate expectations are met through the delivery of effective compliance training programs; and
- tracking, training and reporting on compliance training status.
- The Manager, Compliance Programs will also work closely with the CCO and assist in
- the development of compliance training programs to ensure that standards are clearly communicated to employees;
- conducting inquiries into reports of misconduct; and
- overseeing field and internal compliance monitoring programs.
- The Manager, Compliance Programs will also perform other duties as assigned by the CCO to effectively implement a successful compliance program.
- As system owner for electronic learning management system (LMS), loads content, assigns, tracks, maintains and reports on employee training programs related to company directives, policies and procedures. Conducts follow-up to ensure completion of required training.
- As system owner for electronic steering document management system (LuDo), maintains and updates steering documents.
- Advises and assists business units on development and updating of steering documents.
- Coordinates with CCO and functional head of business units to determine appropriate compliance training plans and compliance training requirements for business units to ensure each employee receives appropriate compliance training for their role. Maintains ongoing updates to these departmental compliance training matrices.
- Tracks all new hire compliance training (Code of Conduct, Adverse Event, etc.).
- Develops and maintains relationships with outside compliance training course vendors with the purpose of identifying and reviewing potential course options. Manages internal course review and selection process. Responsible for Compliance Training Course Content Development:
- Supports, designs and develops courses for Compliance learning programs. Tests and launches training courses.
- Interacts with business units to continually improve content of training courses.
- Manages production of compliance training materials. Ensures all compliance training is assigned and completed for all employees in our company.
- Provides input to CCO on ways to consolidate training by reviewing the full calendar of training (by function, organization, and timing).
- Manages vendor interactions by managing budget, SOWs, verifying vendor invoices, and processing for timely payment.
- Oversees the Field Force Auditing and Monitoring initiatives to ensure compliance with our company’s policies involving speaker programs, advisory boards, sample compliance, and other business activities.
- Participates in internal investigations relating to alleged violations of the Code of Conduct (and other policies and procedures) and in Investigation interviews with CCO. Creates high-level summaries of the findings and conclusions in the Investigation data base.
- Oversees the database of case information and recommends follow-up actions and training. Supports implementation of targeted compliance training as part of corrective actions from audit findings or investigations.
- Responsible for coordinating and developing materials for Compliance Committee and senior management meetings, including benchmarking and internal compliance metrics.
- Coordinates with CCO on
- the annual training calendar,
- aggregate training records including audit of complete and incomplete records, and
- generating training reports.
- Leads strategic projects designed to fulfill the needs of the Compliance Department.
- Ensures compliance training completion documents are audit-ready.
- Executes other related duties as assigned.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Accredited Bachelor’s degree from a University or College.
- 3+ years of Compliance-related experience.
- Excellent oral and written communication/presentation skills to enable effective interaction with all levels of company employees and external partners.
- Ability to develop and facilitate training classes and workshops.
- Experience writing quality system documents in a Document Management system (Documentum and QDMS).
- Demonstrated knowledge and understanding of digital platforms and technologies.
- Self-starter with a strong sense of ownership.
- Demonstrated ability to work effectively in individual and team settings.
- Strong planning, analytical, organizational, and time management skills.
- Keen attention to detail.
- Ability to function in a fast-paced environment handling multiple tasks simultaneously.
- Demonstrated proficiency with Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Instructional design experience
- Hands-on experience supporting a learning management system (Success Factors experience a plus).
- Experience administering live web meetings and training sessions with WebEx, GoToMeeting/GoToWebinar, Lync, or other webinar software.
- 3+ years of training-related experience in a pharmaceutical company.
- Experience in development of training and curriculum design.
- Product or sales management experience.
- Project management experience.
- Advanced Excel skills.
- Willingness/Ability to travel up to 10% domestically. International travel may be required.