Senior Manager, Regulatory Information Management (Remote)

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If you are a Jazz employee please apply via the Internal Career siteJazz 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:The Senior Manager, Regulatory Information Management (RIM), will work closely with R&D and Manufacturing well as other functions within Jazz, to manage training, documentation, user experience, and maintenance of the RIM system and integration with the other systems at JazzEssential Functions
Understand the business processes (across R&D and Manufacturing), regulatory and reporting requirements and converting these into RIM configuration ideas/proposals
Configure RIM (Sandbox, Validation, and Production environments) as per the agreed proposals
Working with other Business and System Leads across Jazz to ensure alignment of data, system configurations and user experience
User requirement gathering and creation of end user reports
Triage support requests from users across GRA and Manufacturing
Develop and deliver data and document migration strategies
Manage RIM user accounts (in conjunction with IT), including user permissions and security profiles
Creation and delivery of RIM training material specific to different levels of knowledge and experience of individuals across R&D and Manufacturing
Knowledge of other systems outside of RIM e.g., Publishing
Required Knowledge, Skills, and Abilities
Education with a minimum of 5 years of pharmaceutical/Regulatory Affairs experience
Veeva White Belt certified
Knowledge of US/EU/International Regulatory Requirements
Ability to manage timely delivery of projects and / or programs
Exceptional written and verbal communication skills
Required/Preferred Education and Licenses
Bachelor's Degree in Business or Life sciences is required
Jazz Pharmaceuticals is an Equal Opportunity Employer.
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