Compliance Officer Policy

**Passion for Innovation. Compassion for Patients.**:
**Compliance Officer (Policy & Procedures) (M/F/x)**:
**Purpose of the function**:
The Compliance Officer (Policies & Procedure) supports the Compliance Management Department on European HQ level to design, develop, implement, and evaluate the Daiichi Sankyo Compliance program and its operational implementation across Europe. The focus of this role is to self-responsibly oversee the development and execution of a comprehensive strategy for the creation and effective communication of compliance relevant polices & procedures at DSE and its European affiliates to prevent violations of applicable law, regulations, rules and ethical standards by employees, agents and others and to ensure that corporate processes remain compliant and up to date with external as well as Daiichi Sankyo internal regulatory requirements, primarily in the field of healthcare interaction. It is important that compliance policies and procedures become a part of the culture of the company. In this role, the Compliance Officer has to closely coordinate with other organizational functions such as the Complinace Officers (Training & Awareness and Monitoring & Data Analytics) as well as international (US, Japan) and/or cross-functional functions such as the Legal Departments or the Medical Departments.

**Roles and Responsibilities**:
**Policies & Procedures**:

- Ensure that the existing Compliance relevant policies & procedures meet the diverse needs of the different user groups as well as the expectation of the regulators. Oversee the development of necessary policies & procedures (and other documents such as guidances), and ensuring a high standard of quality and consistency across all European affiliates. Ensure the accurate and complete capture of active policies & procedures in SOPDB and their revision in regular intervals or ad hoc if necessary.
- Identify opportunities for innovation and creativity in the development and delivery of policies & procedures and other compliance relevant documents (e.g. guidances). Oversee management, including budget, of outside vendors hired to support the handling of policies & procedures.
- Ensure conduct of continuous needs assessments of the organization to address document gaps. Areas of focus for policies & procedures will include adherence to self-regulation and other applicable standards but also mindset in the area of healtcare compliance such as payments to HCPs, promotion, medical affairs activities and travel & entertainment.
- Provide leadership and strategic direction over the company’s policies & procedure infrastructure, philosophy, and approach by working with Internal Audit, other Compliance Officers (Training & Awareness and Monitoring & Data Analytics) and other functions to ensure that standards are incorporated into the strategy and content tailored appropriately.
- Align with and supervise DSE affiliates for harmonization of applicable Compliance relevant policies & procedures.
- Make sure that polices & procedures are communicated effectively and understood by everyone within the organisation, develop roll-out metrics in alignment with GC & CCO Europe and ensure annual metrics are being met. Regularly provide roll-out completion reports to GC & CCO.

**Knowledge Management & Communication**:

- Provides advice and support within DSE regarding healthcare compliance environment and address employee concerns or questions on regulartory compliance.
- Enhance and further develop compliance tools and job aids (e.g. Q&A-lists), electronic and paper-based, to assist employees across the organization in the field of healthcare compliance.
- Keep abreast of internal standards and business goals as well as laws, regulations and Pharma self-regulatory developments.

**Business Collaboration, Regular Advisory & Special Projects**:

- Support the GG & CCO Europe to manage various top priority, complex and multi-dimensional compliance relevant projects that may be assigned to self or team including from a global perspective. If necessary, also support the Legal Department and/or the Risk & Compliance Project Manager in certain projects and participate on global compliance teams to ensure the existence of a cohesive global compliance framework for Daiichi Sankyo.
- Offering and provide regular guidance to business partners in assessing appropriateness of marketing programs, engagements with healthcare professionals, healthcare organizations and patient organizations or patient advocacy groups with regulatory requirements to achieve business objectives in a compliant and ethical manner and ensure the establishment of an effective compliance program (ConTrax and Veeva Promomats material review and approval processes).

**Personal skills and professional experience**:

- University Degree, ideally in Natural Sciences
- 5 to 8 years working experience
- Well trained in compliance policies, procedures, standards and obligations with in-depth k