Job 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:

　　Effectively reviews documents created within or outside of the company 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. Ensures integrity of data in tables against source documents. Instructs others outside of the quality review group on the review process.

　　A day in the Life:

　　Reviews highly technical documents of all types created within or outside of the company to ensure quality standard that meets or exceeds client's expectations.Verifies 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 correctnessAdjusts 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

　　Education

　　Bachelor's degree or equivalent and relevant formal academic / vocational qualification

　　Experience

　　Previous experience reviewing regulatory documents (CSRs, Clinical Protocols, ICFs, etc.), comparable to 2+ years, required.

　　Knowledge, Skills, Abilities

　　Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's messageGood knowledge of the methods, techniques, and procedures of medical writing tasksStrong analytical abilityGood working knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g., ICH), and requirement of the FDA and other international regulatory agenciesDetail oriented, thorough and methodicalProficient grammatical and communication skills, both oral and written Good organizational and planning skillsProven ability to work effectively in a team environmentAdvanced computer literacy and expertiseGood understanding of document management systemsCapable of working well under pressure and remaining motivatedCapable of working both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment

　　Benefits

　　We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.