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Emerging and Changing Regulations Contractor

Newark Metro Area, NJ

Posted: 07/10/2018 Job Type: Scientific Job Number: JN -072018-22014
Description:


1. PURPOSE AND SCOPE OF POSITION:

This position is responsible for managing and administering the Emerging/Changing Regulation Process.

2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Must have expert GMP/GDP, Quality, and in-depth risk management knowledge at a global level;
Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy;
Ability to complete routine tasks with no supervision; Confident in making non-routine decisions in their subject matter area; Able to work proactively. Drives continuous improvement and improves efficiency and productivity within the group or project;
Skilled at getting resources and information from internal and external contacts.



3. DUTIES AND RESPONSIBILITIES:

The candidate will be responsible for managing the Global Emerging and Changing GMP/GDP Regulation and Guidance process.
- Required experience with monitoring emerging and changing GMP/GDP regulations and guidance documents on a global level.
- Ability to coordinate change evaluations and comments.
- Must have the ability to follow up and ensure that impacted documentation is updated within the established timeframe.
- Must have the ability to consolidate, write, and publish reports (experienced technical writer).
- Required experience with monitoring and gaining regulatory intelligence including external observation trends.

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