Coordinator, Global Regulatory Affairs
Category: Research & Development | Country: United Kingdom | City: Oxford | Type: Regular, Full Time | Job ID: 4250
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Coordinator, Global Regulatory Affairs (GRA) is an integral member of the Oxford, UK R&D team providing coordination and administrative support to the EU/ROW Regulatory Team, the VP of Regulatory Affairs Strategy and CMC, and the VP of Global Regulatory Affairs. Activities include but are not limited to scheduling, coordinating and organizing meetings, conferences and department activities; organizing and maintaining the department’s files, records and data, including organizing and storing both electronic and hard-copy records in compliance with the Company’s records management policies and legal and regulatory requirements; assists with purchase orders, vendor invoices and obtaining supplies.
- Organizing and maintaining the GRA electronic and hard copy files and records and updating various databases as needed, ensuring the department’s records are maintained in compliance with the Company’s SOPs and records management policies, as well as legal and regulatory requirements
- Administration of Master Services Agreements and associated Work Orders within JazzAgree relating to external provision of regulatory services
- Maintain an overview of regulatory service providers and reconcile budget with invoices
- Collaborating with cross-functional teams for problem resolution with third party suppliers, contractors
- Creating / editing presentations in PowerPoint and/or charts, graphs, tables, in Excel
- Assisting during audits and health authority inspections as directed by R&D QA
- Scheduling and organizing interdepartmental meetings, meetings with external parties, conferences and other department activities, including catering arrangements
- Meeting coordination and seamless logistical planning
- Making travel arrangements and maintaining travel itineraries
- Maintaining GRA local level calendars as requested
- Assisting with the processing of purchase orders and invoices, and ordering supplies for the department
- Working independently and within teams on special and ongoing projects
- Knowledge of, and aptitude for, organizing and maintaining records and databases
- Knowledge of office management and administrative procedures
- Proficiency in Microsoft Office (i.e. Outlook, Excel, Word, and PowerPoint)
- Ability to demonstrate Jazz values and leadership competencies
Required Knowledge, Skills, and Abilities
- Proven experience working as an Administrative Assistant, Department or Project Coordinator
- Demonstrated ability to multi-task and shift priorities
- Exceptional organizational skills
- Ability to effectively communicate internally and externally
- Works efficiently with little supervision
Required/Preferred Education and Licenses
- At minimum GCSE qualifications or relevant experience
Description of Work Environment
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands
Jazz Pharmaceuticals is an Equal Opportunity Employer.