Jazz Pharmaceuticals (www.jazzpharma.com) is a specialty pharmaceutical company that identifies, develops and commercializes innovative products to satisfy unmet medical needs in neurology and psychiatry. Our unwavering commitment to improving patient care is demonstrated every day through unique patient and physician programs and our ongoing collaboration with patients, physicians and advocacy groups.

As an industry innovator, Jazz Pharmaceuticals takes a focused approach to treating serious conditions that are poorly understood and patient populations who are underserved, as demonstrated by our products and pipeline.

Jazz Pharmaceuticals is a proud recipient of the 2010 Best Places to Work in the Bay Area award.

We are continuing to build a company that is a rewarding and enjoyable place to work, and creative, intelligent, highly-motivated and caring people are essential to achieving this goal. We are searching for innovative, talented individuals to join our collaborative team.

Jazz Pharmaceuticals, Inc.’s Business Information Systems team is seeking a Project Manager with experience in implementation and administration of business applications for various R&D departments which include, but are not limited to, Regulatory, Drug Safety, Clinical, and Quality Sciences.

The Project Manager will:

• Work with business process owners, end users and other BIS project managers to identify and implement new systems and enhancements to existing systems in our IT infrastructure.

• Manage the lifecycle of systems in accordance to our project management methodology which includes development of scope, gathering business requirements and functional specifications, implementation, testing, and deployment.

• Manage the development and optimization of business processes and understand the underlying data that flows through them.

• Handle system testing, troubleshooting, configuration, and administration functions on our business applications.

• Assist business users with the development of standard and ad-hoc reports using various reporting tools.

• Perform computer system validation on processes governed by 21 CFR Part 11 compliance and work with technical writers to create necessary validation documentation.

• Create and maintain project-related documents including system validation scripts.

• Coordinate training, including the creation of printed and on-line training documentation, for both end users and IT staff.

• Schedule and facilitate status and review meetings for team members and project sponsors.

• Work with cross-functional teams to execute project plans.

• Track issues and project status while maintaining an up-to-date project plan.

• Support remote and local end users on IT-related issues.

• Develop, document, and implement best practices to improve business processes.

• Build and maintain relationships with external vendors and business partners.

ESSENTIAL REQUIREMENTS:

• Must have a bachelor’s degree and a minimum of five years of experience in implementing and supporting business applications and managing drug development processes, such as clinical trials management system, drug safety system, quality management system, and FDA submission processes.

• Must have worked with a pharmaceutical company and have a strong knowledge of the drug development processes.

• Must have experience with computer system validation and an understanding of 21 CFR Part 11 compliance.

PREFERRED REQUIREMENTS:

• Experience working with multiple business departments throughout the organization, as well as third-party vendors.

• Able to handle a wide range of IT responsibilities outside of the Project Management scope, such as user support functions.

• Proficient in Microsoft Excel, Word, PowerPoint and Project.

• Able to solve complex problems with little assistance.

• Self-motivated, detail oriented and able to multi-task.

• Excellent communication (oral and written) and problem-solving skills.

• Strong interpersonal/organizational skills.Must maintain superior customer service at all times with all users.

• Must possess the ability to work in a team environment and follow written policies/procedures.

• Must be comfortable in a fast-paced, demanding work environment.

• Experience with SQL and databases preferred.

• Experience in computer system validation and documentation a plus.

• Familiarity with ArisGlobal ARISg, Oracle (Siebel) eClinical, Pilgrim SmartSolve, and/or ISI eCTDXPress a plus.

Relocation is not available. All resumes MUST be submitted via the Jazz Pharmaceuticals Inc. website: https://jazzpharma.tms.hrdepartment.com/cgi-bin/a/highlightjob.cgi?jobid=403&lcid=en-US

No phone calls or faxes, please.