AdresseJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Reporting to the Country Medical Director Germany, and in close collaboration with the (Associate) Medical Directors/ Medical Advisors/MSLs for each therapeutic area, the Medical Project Manager successfully manages local evidence generation and medical projects from initiation to delivery; develops and implements the local evidence generation plans and the medical educational plans that will meet national strategic needs for products registered or under development, within the Jazz Pharmaceuticals Germany affiliate.
Essential Functions
Responsible for planning and overseeing clinical projects according to the company's goals and vision. These projects include company sponsored studies, including real world evidence generation (RWE) and non-interventional studies (NIS), global studies from the Jazz development program, collaborative studies, ISTs, EAPs 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 informed the entire way, ensuring they are completing in a timely fashion and within budget.
- 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 planning and overseeing key Medical Education Projects across TA according to the Medical Plans: Provide state of the art project management and implementation of projects towards achievement of medical objectives while adhering to agreed scope, time, quality and budget;
- 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
- Manage approval of CME-points
- Ensure adherence to relevant regulations including HWG, GDPR, copy rights.
- Monitor progress and make adjustments as needed
- Measure project performance to identify areas for improvement
Missions relating to project management:
Works closely with TA team to ensure a good understanding of their needs and expectations related to projects and the proper implementation of defined strategies.
Monitors the status, progress and finalization of projects by maintaining continuous communication with the various stakeholders.
Establishes strong working relationships with all departments of the affiliate EU/ROW and the Global Medical Affairs teams to ensure the optimization and efficiency of its actions.
Proactively manages changes in the scope of projects, identifies potential risks and issues and develops contingency plans in coordination with medical teams and management.
Provides scientific, medical and technological watch.
Other secondary responsibilities:
- Support MSL 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 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.
Quality System Missions
- In all actions, the Medical Affairs Operations Manager must make a priority commitment to patient safety and product quality by continuously complying with Quality Policy and all other quality processes and procedures documented by Jazz Pharmaceuticals.
Required Knowledge, Skills, and Abilities
Ability to manage scientific and medical projects:
- Good planning and organization.
- Experience in managing medical projects.
- Knowledge of relevant regulations including ICH-GCP, GDPR etc.
- 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 product.
Behavioural skills:
- Shares the company's values. Exceptional team player mindset.
- Can work both independently and in cross-functional teams.
- Able to work with tight deadline.
- 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 rigour and autonomy.
- Is highly motivated and enthusiastic.
Required/Preferred Education and Licenses :
- Relevant science/Business Degree
Miscellaneous :
- Computer skills: affinity for innovative digital solutions like smartsheet etc.
- Fluent and professional English and German (oral and writing)
Jazz Pharmaceuticals is an Equal Opportunity Employer.
