What are the responsibilities and job description for the Compliance Manager position at Fresenius Kabi USA?
The Manager of Compliance will be responsible for the Compliance activities pertaining to Region North America. With oversight and direction from the Compliance Director, will help implement and execute elements of the corporate compliance program. The candidate will work closely with Legal, Compliance and Business colleagues and shall be responsible for helping to manage the company’s compliance with all applicable laws and regulations. This role will have a strong emphasis on leading compliance related projects, documenting policies, procedures, and SOPs, designing and rolling out compliance training, implementing, and testing internal controls, and providing guidance to employees on compliance and ethics matters.
This position requires working onsite 3 days per week at our Lake Zurich, IL U.S. headquarters.
Salary Range : $115,000-$134,900
Position is eligible to participate in an annual bonus plan with a target of 10% of the base salary.
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Job Responsibilities :
Process Excellence
Assist compliance management operations in Region North America (NAM) and support NAM Management Team in their efforts to implement appropriate ICS, SOPs and processes which fulfill the local legal regulations and the Fresenius Kabi Corporate and regional standards.
Support the learning and knowledge sharing activities in the areas of process excellence, ICS and Compliance in the region
Assist in preparation activities for Global internal audits within Region NAM
Compliance
Manage the completion of federal, state, and local transparency-driven compliance requirements.
Review and approve HCP engagements for various departments, including performing Fair Market Value validation. Collect and maintain documentation for HCP engagements.
Monitor and support of compliance classroom trainings and E-learnings on legal entity level in North America. Develop and deliver training in compliance risk areas and regarding global policies.
Records Retention
Work across functional areas to educate and train Records Liaisons in each area to develop consistent processes to implement the Program.
Conduct training and communication outreach strategies on the Program to instill awareness, integration and reinforce compliance. Establish focused group specific training as needed. Supervise the regular training schedule and attestation for regulatory and legal compliance.
Work with IT to establish requirements for the management of all repositories, incorporate lifecycle management requirements into systems design and closeout, and manage lifecycle by working with IT on data maps to show all repositories where information is maintained.
Work closely with the Chief Information Security, Privacy and Compliance representatives on protection of Fresenius Kabi confidential and private information.
Participate in identifying new technology / processes, requirements, vendor interviews and selection of recordkeeping systems, or those systems with recordkeeping functionality.
Assist / develop projects with RIM implications, e.g., Vital Records Identification / Protection, Disaster Recovery Planning, record conversions and file management / clean-up events.
Supervise Record Coordinator responsibilities relating to offsite storage and other RIM-related activities; escalate critical issues to Director and / or business management.
Job Requirements
Bachelor’s degree required
5 years’ work experience in functions such as compliance, legal, audit, regulatory affairs, or finance
Must demonstrate knowledge and understanding of U.S. pharmaceutical compliance issues; knowledge of ex-U.S. compliance laws and regulations and data privacy strongly preferred
CCEP, CIPP or CHC strongly preferred
Advanced PowerPoint and Excel skills
Ability to travel domestically with 1-3 trips on a quarterly basis.
Prior experience in designing training curriculum a plus
Excellent project management skills. Ability to prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data.
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