Manager Regulatory Information Management

Research & Development    ·      Remote Non Sales-USA, California; United Kingdom    ·       Full time

Multiple Locations: Remote Non Sales-USA, California; Remote Office Non Sales Intl, United Kingdom

Categories: Research & Development

Req ID: 6756

Job Description

Jazz 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.

Brief Description:

Manager Regulatory Information Management will lead the Jazz Vault RIM configuration and process development activities. They will work closely with other members of the Regulatory Information Management team to ensure appropriate training material is developed to support end users.

Essential Functions

• Understand the businesses process, regulatory and reporting requirements and converting these into RIM configuration ideas/proposals
• Configure RIM (Sandbox, Validation, and Production environments) as per the agreed proposal
• Complete validation testing (including the writing of UAT test scripts)
• User requirement gathering and creation of end user reports
• Triage support requests from users across GRA, R&D contributing groups, and IT • Develop and deliver data and document migration strategies
• Manage RIM user accounts (in conjunction with IT), including user permissions and security profiles
• Maintain and deliver RIM related training

Required Knowledge, Skills, and Abilities

• Strong understanding of Regulatory activities, projects, and processes (3-5 years of pharmaceutical/Regulatory affairs experience)
• Knowledge of US/EU/International Regulatory Requirements
• Veeva White Belt certified
• Ability to engage and influence system users
• Ability to manage timely delivery of projects and / or programs
• Exception written and verbal communication skills

Required/Preferred Education and Licenses

• Bachelor’s degree

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.

Please click here to apply.