Regulatory Document Review Specialist II/Senior Document Review Specialist (FSP)

At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.   

Summarized Purpose:  

We are excited to be expanding our Medical Writing Functional Service Partnership (FSP) Team in North America. We are seeking an experienced and skilled Document Review Specialist II who will be dedicated to one or more clients in the FSP space to join our team; experience working in a range of document management systems would be preferred. As a remote-based Document Review Specialist within the FSP Team, you will effectively review regulatory documents, including but not limited to submissions documents, protocols and amendments, clinical study reports, investigator’s brochures, and patient safety narratives, to ensure quality standards and adherence to templates, client guidelines, editorial style guides, and industry standards. You will collaborate with internal clients, supporting and enabling effective communication that results in operational excellence and quality deliverables. This role requires meticulous attention to detail, a high English proficiency with the ability to communicate clearly and concisely, and a solid understanding of regulatory document content. 

Key Responsibilities: 

• Reviews highly technical scientific documents of all types developed within or outside of the company to ensure quality standards that meet or exceed client expectations. 
• Verifies scientific logic and clarity of the document by verifying data in tables, listings, and figures against source documents, checking for consistency according to current regulatory standards and guidelines. 
• Edits for accuracy, consistency, and grammatical correctness. 
• Adjusts schedule to accommodate unexpected requests for priority review. 
• Revises scientific language for usage, flow, clarity, and audience appropriateness. 
• Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment. 
• Maintains, communicates, and applies knowledge of current guidelines, templates, and industry standards. 

**This is a document review role only and you will not be responsible for writing**

Education and Experience:  

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification required.  
• 5 years of regulatory document review experience, including protocols, protocol amendments, clinical study reports, narratives, investigator brochures, regulatory responses, and submission modules (primarily Modules 2.5, 2.7.3, and 2.7.4).
• Experience working in the pharmaceutical/CRO industry preferred.  
• If CRO experience: experience working in a client-dedicated role or with 1 to 2 clients over multiple projects is preferred.