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 global 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 regulatory guidelines.

Skills and Abilities:

• Good English language (written and oral) communication skills as well as local language where applicable

• Good attention to detail and quality as well as editorial/proofreading skills

• Good interpersonal skills to work effectively in a team environment

• Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies

• Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects

• Good negotiation skills

• Capable of working independently with direction and exercising independent judgment

• Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables

• Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management

• Basic understanding of medical terminology, statistical concepts, and guidelines

• Good analytical, investigative and problem-solving skills

• Capable of interpreting data

Education and Experience:

• Bachelor's degree/previous experience comparable to 2+ years