Senior Manager, Regulatory Information Management (Remote)

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 Jazz

Essential 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 ., 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 / 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.

FOR US-BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.

For this role, the full and complete base pay range is $128,000-$192,000. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other

pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy.

Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to,

FOR US-BASED CANDIDATES ONLY