Ethics & Compliance Training Specialist conducts needs analyses and designs and implements ethics, business conduct and compliance training and development programs. Interfaces with multiple functional groups outside the ethics and compliance office to ensure curriculum content and methods meet legal, regulatory and corporate objectives. Being an Ethics & Compliance Training Specialist participates in the development and implementation of classroom, web-based and other media training programs for all employees designed to promote knowledge of the corporate code of conduct policies, legal and regulatory requirements of the organization's business. Coordinates with and ensures a uniform level of ethics and compliance training among operating units of the corporation. Additionally, Ethics & Compliance Training Specialist coordinates both internal and external resources required by the program. Provides technical expertise, evaluates content and makes recommendation on incorporating all facets of corporate training programs into the business operation. Requires a bachelor's degree in area of specialty. Typically reports to a manager or head of a unit/department. To be an Ethics & Compliance Training Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com. |
Position Summary
The Associate Director, Compliance Training leads the Wilmington facility in ensuring consistent, applicable, timely and effective GMP-related and compliance training across the organization. This role works to ensure that all employees are well-versed in GMP regulations, guidelines and best practices to maintain compliance with industry and regulatory standards. The role requires collaboration with cross-functional teams, including Manufacturing, Site Operations, Quality and Validation, Regulatory Affairs and Human Resources in the creation, implementation, and evaluation of training programs. |
Primary Responsibilities
Description | % of Time Spent |
Establish a combined compliance and operations training model at the site, ensuring consistency of GMP and Operations training support across all functions on-site. | 20% |
Evaluate existing training structures and approaches, identify inconsistencies and/or training gaps across the organization, build and develop a full-service compliance and training department Collaborate with internal and external stakeholders to establish and improve learning and development processes. Continual assessment of stakeholder needs including learning tools and programs, new learning technology and identification of key metrics for improvements. | 15% |
Appropriate implementation of various training modalities, taking into consideration adult learning styles and preferences. Understanding and application of current technology of training where warranted for most positive impact. Ensure training team has critical skills to support functions across the organization | 10% |
Assess deviation and investigation trends to determine where training should be implemented or improved. | 10% |
Apply appropriate training evaluation models to assess for various levels of training effectiveness; adjusting and continuously improving training programs as indicated by level of evaluation and resultant employee performance | 10% |
Monitor regulatory agency training and observations to ensure compliance to current regulatory standards | 10% |
Use of data analytics to understand gaps and trends in function-related training | 10% |
Working knowledge of Veeva, ComplianceWire and Trackwise; partners with Quality Systems and Compliance to ensure consistent and most beneficial use of training-related systems. | 10% |
Participate in regulatory inspections and customer audit as the site training SME | 10% |
Education Requirement
Required Education Level: Bachelor’s degree in Learning and Education Studies; Education; Teaching and Learning; Human Resources Development or related field.
Preferred Education Level: Master’s degree in Applied Learning and Development, Instructional Design or related field.
Years of Experience: Minimum of 10 years in the pharmaceutical or bio-pharma industry in a compliance, training or educational role.
Other Desired Experience: Proven experience leading a team. Strong knowledge and experience of the end-to-end learning process, program design and delivery and learning evaluation and assessment. Excellent communication (verbal and written) skills, the ability to implement change quickly and effectively across multiple departments.
Working Environment/Physical Demands: If the role requires specific physical demands or working conditions, list all conditions that may apply. For example, this could include lifting heavy objects, standing for long periods of time, description of pace of work, shift work schedules, travel requirements.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
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