This position will report to the VP Corporate Compliance, and will lead the company's Compliance training, communication and reporting programs. This position will be responsible for implementing the Compliance Training and Communication Plans for the global organization with a focus on management of training and communication platforms, creating and designing content for compliance communications, training modules and various compliance reports and presentations. This position will work in partnership with Corporate Compliance, Legal, and various stakeholders throughout the organization.
Essential Functions
Compliance Training:
Support in the implementation of the healthcare compliance strategic objectives
This position will manage the Compliance training strategy and will manage the development and implementation of training initiatives for the Corporate Compliance Program.
Work collaboratively with the VP, Corporate Compliance, Legal and members of Corporate Compliance to ensure effective and efficient pull-through of compliance needs into a training plan and curriculum.
Design and create content for healthcare compliance modules, based on training plan and curriculum, for employees and third-party vendors
Manage the retention and organization of compliance training records.
Help ensure readiness of the organization for training deployment including identifying key stakeholders and determining their needs in advance in order to deliver high quality and effective training modules
Operationalize compliance policies by leading in the design, development, and implementation of training modules and guidance documents in collaboration with cross-functional teams;
Support in conducting needs assessment to identify training gaps for the business, develop customized training to address the needs and soliciting cross-functional feedback before finalizing and roll or of training initiatives
Develop internal communications intended for training, learning and development, and education.
Explore and generate fun, innovative, and creative methods of training to enhance Amneal’s compliance-minded culture.
Maintain a keen understanding of training trends, developments and best practices, including e-Learning.
Management, oversight, and operations of all compliance training and communication platforms and applications.
Compliance Communications:
Responsible for working with key stakeholders and driving the development of key Corporate Compliance internal communications as well as training and engagement related communications.
Contribute to the development of the compliance communications plan, including annual training and communications strategies, plans, objectives, and schedule.
Responsible for implementing the compliance communications plan, including creating all Corporate Compliance communications and compliance reports for Executive stakeholders and compliance updates.
Work with the VP, Corporate Compliance to develop all required internal reports and presentations for various meetings and committees (e.g., Compliance Committee, Board of Directors, and Sales Meetings)
Business Advisory:
Work closely with Marketing, Sales, Medical, and Market Access to provide timely, relevant guidance on applicable laws, company policies and industry codes.
Review, from an Ethics & Compliance perspective, proposed promotional pieces for branded pharmaceutical and biosimilar marketing teams. This task is done along side partners in Legal, Regulatory and Medical.
Additional Responsibilities
May provide direction to other team members.
Education
Bachelors Degree (BA/BS) - Required
Work Experience
10 years or more Knowledge of the Pharmaceutical industry - Required
7 years or more Compliance experience - Required
5 years or more Compliance Training, Communications or Reporting experience. - Required
2 years or more Leading the design and implementation of Pharmaceutical Compliance training or communications programs - Required
5 years or more Project Management Experience - Required
5 years or more General Understanding of Business Operations - Required
Skills and Abilities
Microsoft Office, Microsoft PowerPoint, Microsoft Word and Microsoft Excel essential. - Advanced
Excellent business judgment, communication, writing skills and interpersonal skills. - Advanced
Training Platform skills. - Advanced
A self-starter, must be well-organized and detail oriented and team focused. - Advanced
Able to work independently and problem solve in fast-paced environment. - Advanced
Anticipate/meet the needs of Amneal’s business partners and customers. Be comfortable interacting with all levels of the organization and to respond to requests in an expediated, accurate and appropriate manner. - Advanced
Adept at technology with ability to learn and administer Amneal’s Learning Management System for Compliance related trainings. - Intermediate
Experience with software designed for the development of creative trainings and micro-learnings (e.g. Adobe Creative Suite, Articulate, etc.). - Intermediate
Ability to create an attainable training plan that is tailored to specific audiences (i.e. role-based learning) and execute against that plan. - Intermediate
Specialized Knowledge
Knowledge of State Laws and various Federal Regulations.
Thorough knowledge of federal fraud and abuse laws and guidance, including the ACCME guidelines, the Office of Inspector General reports, and the Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry partners including FDA, OIG, and PhRMA.
Strong understanding of the Prescription Drug Marketing Act (PDMA) – The Prescription Drug Marketing Act of 1987 is a law of the United States federal government. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, and expired prescription drugs.
Demonstrated knowledge and understanding of the required elements of compliance programs and DOJ and OIG expectations related to effective compliance training and communication.
Demonstrated understanding of adult learning principles and how to apply them to effective compliance training and communications programs.
Documented experience in designing, building and implementing a successful compliance training platforms and integrated systems, modules, communication, and educational multi-media programs in a pharmaceutical and/or medical device company.
