Assoc Scientific Writer

Thermo Fisher Scientific•Middleton, WI

1d•Remote

About The Position

This is a fully remote role supporting our GMP Laboratory in Middleton, WI, open to applicants from all locations within the US who are legally authorized to work without sponsorship and can pass a comprehensive background check including drug screening. At Thermo Fisher Scientific, the mission is to enable customers to make the world healthier, cleaner, and safer, providing resources for career goals and advancing science through research, development, and delivery of life-changing therapies. The PPD clinical research portfolio conducts clinical trials in over 100 countries, spanning laboratory, digital, and decentralized clinical trial services. The PPD™ Laboratory services GMP Lab team contributes to improving patient health through the expertise of scientists and therapeutic experts, delivering groundbreaking innovations with a commitment to accuracy and quality. The Associate Scientific Writer 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, and aids in the design, preparation, and review of analytical protocols for validation or analytical studies.

Requirements

Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experience.
Working knowledge of scientific terminology, medical, pharmaceutical and research concepts
Knowledge of word processing, spreadsheets, table and graph generation
Effective written and oral communication skills
Detail oriented
Computer skills including Microsoft Office
Time management skills
Good editorial and proofreading skills
Problem solving and troubleshooting skills
Ability to work well in a collaborative team environment

Responsibilities

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 write Training Materials Documents and Standard Operating Procedures related to Scientific Writing functions.
Works with more senior staff on approach for new assignments.
Performs other duties as assigned.