Assoc Scientific Writer

**Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** This is a fully remote role supporting our GMP Laboratory in Middleton, WI. We welcome applications from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 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. **Location/Division Specific Information:** ------------------------------------------- Our PPD™ Laboratory services GMP Lab team has a direct impact on improving patient health through the expertise of scientists, industry thought leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. **Discover Impactful Work:** ---------------------------- Assists in the coordination and preparation of basic scientific documents under direct supervision. Responsible for preparing and editing scientific documents to meet or exceed quality standards. Assists in the design, preparation and review of analytical protocols for validation or analytical studies. **A day in the Life:** ---------------------- * Prepares and/or assists in the preparation of scientific documents such as next time point creates or other basic shell creation. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Reviews data tables and listings and ensures that errors are corrected. Edits and performs a quality control review of scientific documents prior to creation of the final pdf deliverable. Ensures compliance with PPD, Client, eCTD policy and procedure on publications. * Reviews technical documents for accuracy, formatting, consistency and compliance to protocols or SOPs. * May represent the laboratory on project teams and update team members on the status of study reports. Acts as a liaison on interdepartmental projects when reports are required. * Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents. May help writ