Compliance Officer (f/m/d)

• Implement and oversee the operation of the Compliance & Governance Framework in the DACH Area.
• Ensure that there is consistency in the interpretation and understanding of applicable policies and processes to provide timely, collaborative and constructive engagements across the DACH cluster
• Translation and validation of all regional compliance policies, documents and statements
• Advise the Associate Director EMENA – Processes & Controls where local laws and regulations require additional or separate Compliance Processes
• Review and document local policy variations and submit for approval by the Associate Director EMENA - Process & Controls (and ensure that all compliance related documentation is regularly reviewed for accuracy and completeness and is accessible in a secure location.)
• Manage the quarterly compliance framework program for the DACH cluster, ensuring questionnaires and documentation is circulated, certified, returned and stored in a secure and auditable manner
• Oversight of the material validation and certification process pertaining to the local Healthcare Compliance Regulations
• Management of the Healthcare Needs Assessment (HNA) process to ensure adequate and appropriate records are kept with regards to event approvals and local certification documentation requirements
• Ownership of the local Compliance registers for Sponsorships, donations, grants, donations and conflicts of interest
• Management of the local Transfer of Values (ToV) process, including the collection of data, Validation and annual disclosure reporting
• Management of the local KYBP process and the performance of compliance Due Diligence for High Risk/ abnormal business partners in collaboration with the Associate Director EMENA – Processes & Controls
• Management of the local Dawn Raid responsible persons register and process
• Provision of data to the Associate Director EMENA – Data Protection & Privacy to enable the maintenance of adequate and accurate processing activities registers
• Support the DACH cluster with the preparation of their risk and asset registers and in understanding the process of identifying risk
• Identification of high risk processes and operations to ensure that appropriate risk reduction strategies or mitigation measures are proposed and implemented, once approved
• Assist and support with the Internal and external Audit programs in relation to risk and compliance processes and controls within the DACH cluster
• Delivery of the regional compliance induction programme for all new DACH staff, to provide a clear understanding of compliance and the importance placed on it by the organisation
• Act as first point of contact for all DACH compliance and data privacy inquiries, providing advice and guidance as required
• Support any investigations for allegations concerning possible violations of the Code of Conduct and other policies, procedures, laws and regulations, within the DACH cluster
• Provide reports and statistical data for the DACH cluster management teams & Regional Compliance team where required
• Support of ad hoc and ongoing Regional Compliance projects

• Customer Focus: is dedicated to meeting the expectations and requirements of internal customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.

• Peer Relationships: can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.

• Problem Solving: uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.

• Dealing with Ambiguity: can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty. 

Relevant Functional/Technical Skills or Industry Experience

Essential:

• Previous pharmaceutical industry experience

• Commitment to CPD

• Experience of risk management/control systems/compliance or governance.

• Experience of generating management information and reports

• Sound understanding of relevant legislation.

• Sound communication and interpersonal skills.

• Capable of working on own initiative

• Proactive approach to problem solving.

• Flexibility in line with changing priorities.

• Meticulous attention to detail.

• Sound MS Office skills.

Desirable:

• Experience and appreciation of differing business cultures.

Relevant Professional / Educational Background:

Essential:

• Healthcare Compliance Qualification (or equivalent)

• Experience of a working in a high profile Compliance role within a Pharmaceutical or other highly regulated organisation

• Working knowledge of GDPR

• Understanding of local corporate governance requirements

Desirable:

• Understanding of Sarbanes Oxley.

• Knowledge of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code of Practice

• Knowledge of the Medicines for Europe (MfE) Code of Conduct

• Knowledge of the ABPI and IHCP requirements

Please note that this role will require travel to other sites across Europe with some overnight stays