Reporting to the Head of EUR/INT Evidence Optimisation and Managed Access Team this position will be an integral member of the Evidence Optimisation and Managed Access Team and is responsible for advising and guiding the execution of real-world evidence (RWE) studies in the EUR/INT region.

This is a business-critical role, designed to deliver meaningful change in the way evidence generation is operationalised and executed across the entire EUR/INT organisation. The position is responsible for collaborating with leaders across the organisation to ensure the efficient and effective generation of evidence that supports our business needs and optimises patient outcomes.

Essential Functions

Advisory and Strategic Planning:

• Provide expert advice on the design and implementation of RWE studies.

• Identify evidence gaps and recommend appropriate study types to fill these gaps.

• Collaborate with cross-functional teams to develop and implement an evidence generation strategy.

Operational Excellence:

• Develop and manage the operating model for evidence generation.

• Ensure compliance with regulatory requirements and internal standards.

• Promote efficiency, cost-effectiveness, and quality in evidence generation activities.

Stakeholder Engagement:

• Engage with key stakeholders to secure support and resources for evidence generation.

• Provide training and educational materials to stakeholders involved in RWE studies.

• Foster strong partnerships across the organisation to enhance the impact of evidence generation.

Financial Management:

• Monitor budgets for evidence generation activities.

• Provide financial forecasts and updates to senior management.

• Advise on cost-effective measures for planned studies.

Governance and Compliance:

• Develop and implement governance frameworks for RWE studies.

• Ensure adherence to relevant SOPs, policies, and regulations.

• Lead efforts to mitigate risks and address barriers to effective evidence generation.

Required Knowledge, Skills, and Abilities

• Substantial experience in the pharmaceutical industry in either medical affairs or clinical operations/development

• Demonstrated experience with developing, documenting, and communicating operational strategy

• Ability to effectively lead cross-functional stakeholders and create strong partnerships across the organisation

• Demonstrated knowledge of GDPR and GxP regulations, clinical standards, and industry best practices for RWE/observational studies

• Demonstrated record of issue resolution and effective collaboration with a variety of internal and external stakeholders

• Excellent program and project management, financial management and planning skills

• Demonstrated understanding of Medical Affairs/R&D and clinical studies

• Advanced understanding of clinical study structure, costs and CRO management

• Able to work in a fast-paced, flexible, team-oriented environment; flexibility is important due to changing nature of the projects the team will be working on at any particular time

• Excellent verbal, written, analytical and interpersonal skills

• Entrepreneurial skills with emphasis on innovation and a high motivation to partner with customers

• Strong IT skills with a “hands-on” approach to maximizing data input and output and analysis

• Excellent organizational skills and ability to effectively prioritise

• Strong in collaboration and a team player, able to work across multiple departments within the organisation, as well as externally

• Demonstrates a ‘can do’ approach with a willingness to undertake all tasks required to support the medical affairs function in a rapidly evolving organisation

• Be able to work without close supervision; well-developed time management skills are important

• Excellent presentation skills

• Excellent command of written and spoken English

Required/Preferred Education and Licenses

• Degree level or higher, preferably in a Science related field.