Ethics & Compliance Manager Barga

Ethics & Compliance Manager
Barga
Toscana, Barga

Ethics & Compliance Manager Under the supervision of the Global Compliance Officer, designs, implements and manages Ethics & Compliance ("E&C") initiatives at global level and for specific markets in which Kedrion operates including, but not limited to, the following activities: • Completing and updating periodic compliance risks' assessments.

• Developing and maintaining 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 System in the countries where Kedrion operates.

• Drafting and implementing compliance-related policies and procedures, keeping an oversight of version control, change tracking and effective roll-outs.

• Conducting training and executing communications initiatives.

• Designing and implementing compliance controls into Company's processes.

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

• Conduct and facilitate auditing and monitoring activities.

• Conduct and facilitate third party due diligence activities, including review and approval processes.

• Implement digital tools supporting compliance activities.

• Administer the Kedrion Global Speak Up Program and E&C investigations.

• Periodically report to the Management of the Company on the outcomes of the monitoring activities and other E&C initiatives.

Supports the Global Compliance Officer and the Global Ethics & Compliance Team in identifying areas of improvement for the Global Ethics & Compliance System, with an intent to focus on the Commercial Organization.

Participates in the development of performance improvement projects (e. g.

definition and measurement of compliance metrics, . . . ).

Partners with Company Functions (e. g. , Legal, Finance, IT, HR, Internal Audit, Quality, Commercial, etc. )

to ensure that the E&C System is properly designed and effectively implemented in the different areas of the Kedrion Organization and to provide independent advice to manage compliance risks.

Requirement: • Bachelor's Degree • 6-8 years relevant compliance experience, in pharma, biotech or medical devices • Understanding of the basic elements of an effective compliance program and guidance issued by the DoJ and OIG) • Strong communication and interpersonal skills (i. e. , ability to express facts and ideas clearly and concisely, both orally and in writing, listening and getting clarifications, answering questions) • Strong skills in analytical thinking, specifically, ability to identify and define problems, collect data, establish facts and develop substantiated conclusions.

• Excellent attention to detail and accuracy • Ability to manage multiple projects requiring cross-functional collaboration and to work under multiple time deadlines • Problem solving and solutions orientation • Maintain confidentiality in all matters • Intermediate to advanced computer skills including Microsoft Office Suite (i. e.

Excel, Word, Outlook, PowerPoint) • Ability to work with independently, 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 • Willingness and ability to travel as necessary (not to exceed 25%) • Fluent English and Italian are required (knowledge of additional languages of countries where Kedrion operates is highly appreciated) • Experience with regulations on Healthcare Compliance and interactions with Healthcare Stakeholders (Healthcare Professionals, Healthcare Organizations, Patients Organizations, Payors , . . . ) (preferred but not required) • Knowledge of Anti-bribery legislations (e. g. , Foreign Corrupt Practices Act, UK Bribery Act, Italian Law Decree nr.

231/01, . . . ) • IAPP Certification (e. g. , CIPP/US, CIPM, CIPT) (preferred but not required) Location: Castelvecchio Pascoli, Barga (LU)