Emerging and Changing Regulations Contractor
Newark Metro Area, NJ
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.