.This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Work Schedule: OtherEnvironmental Conditions: OfficeJob Description: At Thermo Fisher Scientific, you'll 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.Discover Impactful Work: We are looking for a Senior Document Review Specialist to join our FSP Medical Writing team. This role would be dedicated to one client and fully remote, working from certain EMEA locations. As a Senior Document Review Specialist, you will review documents to ensure quality of a standard that meets or exceeds client's expectations. Documents include regulatory submissions, integrated clinical study reports, serious adverse event narratives, study protocols and publications. You will be ensuring integrity of data in tables against source documents, instructing others outside of the quality review group on the review process.A Day in the Life:Reviews highly technical documents of all types to ensure a quality standard that meets or exceeds client expectations.Ensures scientific logic and clarity of the document by verifying data in tables 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.Coordinates the work of team members and tracks the status of documents being reviewed.Mentors junior team members.May represent the department at meetings with clients.Contributes to the development and modification of the quality review process.Collaborates with the writer to manage alliance account(s).Delegates weekly assignments to the quality review team and fields questions as appropriate.Keys to Success: Bachelor's degree or equivalent and relevant formal academic / vocational qualification
