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.
Jazz Pharmaceuticals’ Information Technology (IT) department is seeking a Manager to facilitate the day-to-day operations of Jazz’s Veeva Vault ecosystem (including RIM, eTMF, and PromoMats), or other IT systems supporting Jazz’s R&D business functions. Operational responsibilities include the creation, review, and maintenance of operations plans and validation deliverables and documentation, manage routine system upgrades and enhancements, and partnership with other Jazz/IT functions (i.e. Compliance, QA, and InfoSec teams) to ensure R&D system compliance and operations. In-depth understanding of Veeva Vault and associated regulatory submissions, eTMF, and promotional material processes are essential, so we can effectively partner with and lead our business counterparts
This role can be based in Palo Alto, CA or Philadelphia, PA.
- Collaborate with Business Process Owners and IT R&D Capability Enablement Leads to maintain and upgrade Jazz’s Veeva Vault ecosystem, including: RIM, eTMF, and PromoMats Vaults
- Work in collaboration with the Jazz Global Regulatory Affairs, R&D Quality teams, Veeva, and third parties to manage system fixes, enhancements, and maintain GxP compliance with Veeva’s tri-annual system releases
- Follow Jazz GxP change management procedures and coordinate with business partners to identify, define, resolve or implement issues/requests, and perform validation testing activities
- Create, update, and manage operational and system (GxP) documentation and test scripts
- Work with vendors, IT business leads, and other R&D functions to resolve system defects and harmonize technology with business process
- Plan and execute routine system owner activities, including conducting quarterly user access reviews, managing system upgrades, developing a systems roadmap, routine disaster recovery testing, license management, etc.
- Manage various aspects of projects and operations, including scope definition, resource allocation, and budgets
- Closely collaborate with the relevant IT, Quality, and other Jazz teams to define and ensure the proper balance of risk mitigation, operational assurance, and validation activities for Jazz’s Vault Systems
- Work with Capability Enablement Leads to transition new systems implementation to operations
Required Knowledge, Skills, and Abilities
- In-depth, procedural and technical, understanding and working knowledge of Veeva Vault is required (specific experience with RIM, eTMF, and PromoMats, Vault Loader, etc. is a plus)
- Veeva Vault Certification is plus
- Experience authoring and working with IT GxP validation and other operational assurance documentation, e.g. URS, FRS, data migration protocol, disaster recovery plan, etc.
- Experience with IT system ownership and systems operations
- Ability to work independently to prioritize support activities and operational needs
- Create and maintain systems documentation and operational plans
- Ability to work with business partners to balance and prioritize business needs along with resource availability, budgets, and timelines
- Good understanding of cloud computing / SaaS (software as a service) and exposure to web-based technologies
- Strong written, oral and interpersonal communication skills
- Strong analytical skills and methodical troubleshooting ability
- Excellent organizational and follow-up skills with strong attention to detail
- Ability to work effectively in a fast paced and collaborative environment
- Understanding of clinical research and drug develop processes and functions
- Experience working in a regulated GxP environment is desired
- Experience with managed services provider (MSP) oversight is a plus
Required/Preferred Education and Licenses
- Bachelor's degree (B.A. or B.S.) from a four-year accredited college or university and 3 years of relevant experience; or equivalent combination of education and experience.
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.