• Global Ethics & Compliance Manager

    Kedrion Biopharma, Inc.Fort Lee, NJ 07024

    Job #2660347513

  • The Global Ethics & Compliance Manager ("Manager") contributes to the design, implementation and continuous improvement of the Global Ethics and Compliance System of Kedrion Biopharma (e.g., written guidelines, trainings and awareness initiatives, internal controls and monitoring system, Speak Up and periodic reporting) for the assigned company business lines and/or functions. Position can be located as hybrid schedule out of our Fort Lee, NJ office or Durham, NC.

    Main responsibilities:

    Under the supervision of the Global Compliance Officer in the U.S, the Manager will support the development and implementation of the global and local Ethics & Compliance ("E&C") programs in the assigned Legal Entities and company Functions, including, but not limited to, the following activities:

    General

    Design, implement and manage:

    • Training and communications initiatives.

    • Internal reporting with the integration of compliance into business processes.

    • Compliance-related policies, procedures/processes and tools (e.g., FMV, HCP transparency, engagements with HCPs) keeping an oversight of version control, change tracking and effective roll-outs.

    • Presentations on E&C topics/initiatives during meetings with company's internal and external stakeholders.

    • Trainings on Healthcare Compliance policies/procedures/tools.

    • Periodic risk assessments.

    • Auditing and monitoring activities.

    • Third party due diligence activities, including review and approval processes.

    • Systems and processes for monitoring changes in applicable laws and regulations (including industry guidance and best industry practices) that are relevant to or impact the E&C Program in the countries where Kedrion operates.

    • Digital tools supporting compliance activities.

    • Manage internal E&C investigations and support other functions on investigations assigned.

    Support the Global Compliance Officers and the Head of Global Compliance in identifying areas of improvement for Global Ethics & Compliance Program and participates in the development of performance improvement projects (e.g., definition and measurement of compliance metrics, etc.

    Qualifications

    • Bachelor's Degree

    • 6-8 years relevant experience, preferably in pharma or biotech

    • Knowledge of Foreign Corrupt Practices Act, Anti-Kickback Statute, and U.S. Physician Open Payments Act; knowledge of E&C principles (e.g., basic understanding of the basic elements of an effective compliance program and guidance issued by the DoJ and OIG)

    • Strong skills in analytical thinking, specifically, ability to identify and define problems, collect data, establish facts and develop substantiated conclusions.

    • Strong project management skills with the ability to manage multiple projects requiring cross-functional collaboration

    • Excellent attention to detail and accuracy

    • Ability to work effectively under multiple time deadlines.

    • Ability to identify and resolve problems in a timely manner and analyze information skillfully; ability to assess risk exposure and appropriately escalate

    • Maintain confidentiality in all matters

    • Ability to express facts and ideas clearly and concisely, both orally and in writing.

    • Intermediate to advanced computer skills including Microsoft Office Suite (i.e. Excel, Word, Outlook, PowerPoint).

    • Excellent interpersonal and organizational skills; listens and gets clarification; responds well to questions.

    • Ability to work with independently with under general guidance and supervision

    • Ability to professionally interact with all levels of employees up to Executives, BODs, Attorneys, etc.

    • Willingness and curiosity to learn

    • Fluent English (knowledge of additional languages of countries where Kedrion operates is highly appreciated)

    Kedrion Biopharma offers a number of benefits to qualifying employees, including:

    • Medical, vision and dental insurance

    • Life and AD&D insurance

    • Paid holidays

    • PTO accrual

    • and much more!

    Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

    Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.