Nature and Scope:
The Compliance Operations Specialist Sr. is responsible for the execution and continuous improvement of the Company’s Compliance Program. This position will be responsible for creating and assisting in the development of compliance program, policies, trainings (including developing eLearning modules) and written communications. This individual will partner with Compliance Leadership, department colleagues, and all business areas. This position will also assist in the development, understanding of, and adherence to the Compliance Program and the Company’s U.S. SOBC, and will be responsible for managing the aggregate spend activities and reporting for all U.S. State and Federal laws and regulations.
Essential Duties and Responsibilities:
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- Training & Communications:
- Plan, create, draft and deliver various, innovative training vehicles to inform and educate employees on compliance issues through the utilization of existing and novel technological solutions (including various e-Learning software such as BrainShark, Articulate, and Camtasia) in accordance with the approved Compliance Training Plan.
- Evaluate Compliance modules developed by the Compliance function against specific, impacted ARI policies and procedures to ensure consistency and accuracy; recommend/draft changes where needed and appropriate.
- Conduct in person and virtual new-hire Compliance training on an as-needed/as-requested basis.
- Project manage various teams to build creative training programs from conception through deployment.
- Participate in the development and tracking of a multi-year policy and procedure training curricula for use across commercial, development and manufacturing sectors; as well as external vendors who may require Compliance training.
- Plan, create, draft and disseminate regular compliance communications in accordance with the approved annual Compliance Communications Plan.
- Identify areas of need and make recommendations for new or additional training or communications topics.
- Policy:
- Draft Compliance policies and procedures.
- Support the Compliance team in developing and tracking adherence to the annual Compliance Policy and Procedure Plan.
- APP (Administrative Policy and Procedure) Coordinator – Serve as the primary point person for the management of the APP process at ARI. This includes the collection, review, dissemination and recordkeeping for all Form 1 documents and associated corporate documents (policies, procedures and work instructions). Set agendas for APP meetings and ensure adherence to APP process including approval requirements by department head and APP Committee members.
- Work with document Authors and Functional Coordinators to ensure that they are properly trained and adhere to document creation standards pertaining to the development, creation, revision, and retirement of all corporate documents.
- Publish and maintain a library of all current, approved non-GxP policies and procedures and ensure these documents are accessible to all employees.
- Additional Responsibilities:
- Process all donations and charitable contribution requests, and maintain and share quarterly updates, as required.
- Prepare management reports regarding compliance operations and progress, including to ARI’s Compliance Committee and Board of Directors, as needed.
- Support the compliance investigations process, as needed, through accurate recordkeeping in appropriate systems, coordinating and scheduling interviews or other investigative meetings, and participating in internal investigations.
- Manage the Aggregate Spend activities and reporting in accordance with all U.S. State and Federal laws and regulations.
- Maintains understanding of laws and regulations, enforcement actions and evolving best practices relevant to pharmaceutical compliance and proposes updates to Compliance program.
Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Bachelor's Degree required. Additional education/certification within healthcare or Compliance related fields is preferred.
- Minimum of 5 years’ experience in a regulated/assurance function within the healthcare industry required (e.g. Compliance, Regulatory Affairs, Quality Assurance, Legal Affairs).
- 2-3 years’ experience of training and/or training development with experience in Compliance and/or industry regulations required.
- 2-3 years’ experience drafting policies and procedures within a regulated industry required.
- 2-3 years project management experience preferred.
- Risk Management experience is preferred.
- Detail-oriented strong organizational skills and self-sufficient, with the ability to drive projects to completion with the utmost integrity.
- Ability to manage varying workload, set priorities accordingly, and maintain deadlines.
- Address confidential matters with discretion and judgment.
- Excellent communication and interpersonal skills required, with the ability to interact collaboratively with all levels of the business.
- Strong proficiency in Microsoft Office (Word, Excel, PowerPoint) and Outlook.
Physical Environment and Requirements
- Up to 10% travel required
Expected Salary Range:
$91,300- $102,000
The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide
range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.