Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our general teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Summary of Essential Functions:
Essential Document Pack (EDP) reviewer is responsible for the review and approval of the country and site essential documents. The EDP contains at a minimum the most critical essential documents required for site activation. The documents required to be collected for each study site/country will be documented in a study-specific Essential Document Compliance (EDC) Review Checklist.



Once final study documents are available, the EDP is reviewed for all required essential regulatory documents for completeness, accuracy and quality. The packs are reviewed by designated EDP reviewers who are independent from the study.
Key responsibilities:
Review country essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist.
Review site essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist.
Notifies EDP Submitter via email of review outcome detailing requested revisions and/or corrected documents when deficiencies are noted.
Review revised packs to ensure deficiencies were resolved and communicate review outcome to the SSU Specialist.
Tracks EDP review details in the applicable data tracking system.
Maintain knowledge and understanding of SOPs, client SOPs/directives, and current regu

📌 FSP Essential Document Pack (Ciudad de México)
🏢 Thermo Fisher Scientific
📍 Ciudad de México