Brief Description

During the fixed-term assignment, reporting to the Therapeutical Area Medical Director Spain & Portugal, and in close collaboration with the Medical Advisors for each therapeutic area, the Medical Affairs Operations Associate Director successfully leads the local evidence generation and medical projects from initiation to delivery; you will design, develop and implement the local  evidence generation plans and the medical educational plans that will meet national strategic needs for products registered or under development, currently in   Oncology (main focus) and Neurosciences, within the Jazz Pharmaceuticals Iberia affiliate. You will lead all PA and transversal medical projects. The incumbent is responsible for ensuring all activities are executed in accordance with regulatory and legal frameworks including but not limited to GCP, IFPMA, FarmaIndustria Code of Conduct and local regulations as well as Jazz Pharmaceuticals Policies and Healthcare compliance procedures.

Essential Functions/Responsibilities

• Responsible for leading, designing, planning, and overseeing JPI clinical projects according to the company's goals and vision. These projects include Company Sponsored Studies, ISTs as well as the coordination of other RWE data collection projects such as third parties’ databases analysis:

• From planning to publication, and follow-up the compliance of deadlines established in current laws, regulations, guidelines, procedures and policies and follow-up of main milestones of the project in collaboration with TA.

• Plan and designate project resources, prepare budgets, monitor follow-up of main milestones of the project, develop project charters, comprehensive plans, success criteria, metrics, status reporting, communications, and other deliverables to ensure successful delivery of the evidence generation projects.

• Negotiate contracts with vendors of medical services.

• Assist with study protocol development, study materials and study report completion.

• Coordinate study supplies when required.

• Keep internal and external customers engaged and informed the entire way, ensuring they are compelling in a timely fashion and within budget.

• Serve as the point of contact with the Global Team and become the MEGS Platform Champion at Iberia

• Assist with the local Publication Plan and ensure that documents comply with International Conference on Harmonisation guidelines, Jazz Pharmaceuticals SOPs, and Good Clinical Practices Comparative evidence.

• Identify process opportunities, design, and implement improvement tools.

• Responsible for leading, planning and overseeing key Medical Education Projects across TA according to the Medical Plans: Proactively manage projects towards achievement of medical objectives while adhering to agreed scope, time, quality, and budget:

• Develop and manage a detailed project schedule and work plan.

• Prepare budget based on scope of work and resource requirements.

• Provide project updates on a consistent basis to various stakeholders about strategy, adjustments, and progress.

• Manage contracts with vendors and suppliers by assigning tasks and communicating expected deliverables.

• Monitor progress and make adjustments as needed.

• Measure project performance to identify areas for improvement.

• Responsible for JPI projects with Patient Associations in coordination with the Medical Director and Medical Advisors. 

• Develop and execute the projects with PA.

• Prepare budget based on scope of work and resource requirements.

• Provide project updates.

• Manage contracts with vendors.

• Monitor progress and identify areas of improvement.

Missions Relating to Project Management:

• Works closely with Medical Advisors and Medical Director to ensure full alignment with JPI medical strategic priorities of

• Lead and monitors the status, progress, and finalization of projects in collaboration and coordination with all internal and external stakeholders.

• Establishes strong working relationships with all departments of the affiliate,  EU/INT, and the Global Medical Affairs teams to ensure the optimization and efficiency of all projects.

• Proactively manages changes in the scope of projects, identifies potential risks, and issues and develops contingency plans in coordination with medical team and senior management.

• Provides scientific, medical, and technological watch.

Relations with Health Professionals and Patient Associations:

• Develops professional relationships with key external experts (KEEs), scientific societies and patient associations in the therapeutic areas under his/her responsibility(currently Oncology/Hematology (main focus) and Neurosciences in a near future).

• He/she will participate in relevant scientific conferences and congresses, round tables and/or advisory boards, to maintain an optimal level of scientific knowledge, to understand developments in the therapeutic areas and to engage with key stake holders.

Other Secondary Responsibilities:

• Support Medical Advisors (and MSLs if needed)  in the preparation of their RGRC presentation for ISTs submitted by External Experts on the JAZZ IST portal.

• Provide training on evidence data generation processes and overall methodology to MSLs.

• Become the MEGS Platform lead and the IST platform Champion.

• Support and facilitate communication in collaboration with the therapeutic area medical director between academic centers/cooperative groups and JAZZ global medical affairs/clinical development for collaborative studies.

• Reports adverse events and product complaints as they are made aware in accordance with internal procedures.

Quality System Missions

• Reports adverse events and product complaints as they are made aware in accordance with internal procedures.

Required Knowledge, Skills, and Abilities

Has Scientific Expertise Enabling to:

• Elaborate and conduct non-interventional studies.

• To carry out exhaustive and relevant bibliographical analyses and the critical reading of scientific articles.

• To know and understand the methodology and foundations of clinical development.

• To conduct scientific exchanges.

Ability to Manage Scientific and Medical Projects:

• Good planning and organization.

• Knowledge about the steps of data management (including the design of a data validation program, the design of the CRF, etc.).

• Ability to analyze complex data and produce syntheses.

• Demonstrates strong oral and written communication, interpersonal and presentation skills.

• Demonstrates strong adaptability. Responds and reacts actively to changing situations or information.

• Mobilizes the necessary resources.

• Has the ability to manage a large volume of projects simultaneously while delivering a quality end result.

Behavioral Skills:

• Respects and shares the company's values.

• Can work both independently and in cross-functional teams.

• Able to work with tight deadlines and in a context of patient urgency.

• Must be able to prioritize and multi-task, work effectively, and build collaborative relationships with management, partners, and peers from diverse backgrounds in a matrix organizational structure.

• Develops professional relationships in an ethical manner.

• Has a keen sense of listening and communication.

• Demonstrates rigor and autonomy.

• Is highly motivated and enthusiastic.

Other Skills Desired:

• Good understanding of local healthcare systems.

• Ability to interact with scientific societies and patient associations.

• Ability to interact with patient associations.

Required/Preferred Education and Licenses

• Graduate with a higher scientific qualification e.g. MSc, PhD, or pharmacy etc.

• Experience in Clinical Development-Project Management Professional (PMP) a plus.

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