Senior Manager, Regulatory Information Management (Remote)

Jazz Pharmaceuticals; Oxford; Remote; GBP 96,000 - 146,000; Full time

Job summary

A leading biopharmaceutical company in Oxford seeks a Senior Manager for Regulatory Information Management to oversee the RIM system's training and documentation. The ideal candidate will have over 5 years of experience in pharmaceutical regulatory affairs and a Bachelor's degree in Business or Life Sciences. This role offers competitive compensation and the chance to work in an innovative environment with continuous development opportunities.

Benefits

Discretionary annual cash bonus

Equity grants under Long Term Equity Incentive Plan

Qualifications

• Minimum of 5 years of pharmaceutical / Regulatory Affairs experience.
• Knowledge of US / EU / International Regulatory Requirements.
• Ability to manage timely delivery of projects and/or programs.

Responsibilities

• Manage training, documentation, and user experience of the RIM system.
• Configure RIM according to agreed proposals.
• Work with system leads to ensure data and user experience alignment.

Skills

Pharmaceutical / Regulatory Affairs Experience

Veeva White Belt Certification

Exceptional Communication Skills

Education

Bachelor's Degree in Business or Life Sciences

Job description

Brief Description

The Senior Manager, Regulatory Information Management (RIM), will work closely with R&D and Manufacturing as 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.
• Work 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