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Associate Director, Medical Affairs Evidence Optimisation

3+ years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, Medical Affairs Evidence Optimisation
Location: München, Bavaria, DE -- [Remote/Home-Based]
Req ID: R010211
Category: Commercial

Company Overview:
Jazz Pharmaceuticals is a global biopharma company that aims to innovate and transform the lives of patients by developing life-changing medicines for individuals with serious diseases, often with limited or no therapeutic options. Jazz has a diverse portfolio, including therapies for sleep disorders, epilepsy, and a growing portfolio of cancer treatments. The company is headquartered in Dublin, Ireland, and operates globally with research and development laboratories, manufacturing facilities, and employees dedicated to serving patients worldwide.

Position Overview:
The Associate Director, Medical Affairs Evidence Optimisation will be a vital member of the EUR/INT Evidence Optimisation and Managed Access Team. The role is designed to advise and guide the execution of real-world evidence (RWE) studies in the EUR/INT region. It is a business-critical position aimed at transforming how evidence generation is operationalized and executed across the organization, ensuring efficient, effective evidence generation that supports business needs and optimizes patient outcomes.

Key Responsibilities:

  1. Advisory and Strategic Planning:

    • Provide expert guidance on the design and execution of RWE studies.

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

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

  2. Operational Excellence:

    • Develop and manage the operational model for evidence generation.

    • Ensure compliance with regulatory requirements and internal standards.

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

  3. 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 organization to enhance evidence generation impact.

  4. Financial Management:

    • Monitor and manage budgets for evidence generation activities.

    • Provide financial forecasts and updates to senior management.

    • Advise on cost-effective measures for planned studies.

  5. Governance and Compliance:

    • Develop and implement governance frameworks for RWE studies.

    • Ensure adherence to SOPs, policies, and regulations.

    • Mitigate risks and address barriers to effective evidence generation.

Required Knowledge, Skills, and Abilities:

  • Extensive experience in the pharmaceutical industry, particularly in medical affairs or clinical operations/development.

  • Proven expertise in developing and communicating operational strategies.

  • Strong leadership skills and the ability to create partnerships across the organization.

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

  • Experience with issue resolution and collaboration with internal and external stakeholders.

  • Exceptional program and project management, financial planning, and organizational skills.

  • In-depth understanding of Medical Affairs/R&D and clinical studies, including clinical study structures, costs, and CRO management.

  • Able to work in a fast-paced, team-oriented environment with flexibility due to the evolving nature of projects.

  • Excellent verbal, written, and interpersonal communication skills.

  • Strong IT skills with a hands-on approach to data input, output, and analysis.

  • Ability to manage time effectively and prioritize tasks.

Education and Licenses:

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

Additional Information:
Jazz Pharmaceuticals is an equal opportunity employer and provides consideration to all qualified applicants, regardless of race, religion, sex, or other protected status. The successful candidate will also be eligible for various benefits, including medical, dental, and vision insurance, retirement savings plans, and flexible paid vacation. For more information, visit
Benefits page.