Technical Writer - GMP

Thermo Fisher Scientific•Middleton, WI

2d•Remote

About The Position

This is a fully remote role supporting our GMP Lab in Middleton, Wisconsin. We welcome applicants 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. Our PPD® Laboratory Services 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. Summary: Assists in the preparation and review of scientific documents under general supervision to meet or exceed quality standards. Writes and edits basic to moderately complex analytical methods, reports and protocols for potential submission to regulatory authorities.

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 2+ years’) or equivalent combination of education, training, & experience.
Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts
Good knowledge of word processing, spreadsheets, table and graph generation and use of applicable computer software
Working knowledge of industry regulations, ICH or other regulated environments
Working knowledge of analytical laboratory procedures
Effective written and oral communication skills
Detail oriented
Time management skills
Good editorial and proofreading skills
Good problem solving and troubleshooting abilities
Ability to work well in a collaborative team environment
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Responsibilities

Prepares and/or assists in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOPs, client correspondence and other similar documentation.
Compiles laboratory data into a specified report format.
Ensures that hardcopy and electronic reports are consistent and comply with required formats.
Reviews data tables and listings and ensures that errors are corrected.
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 scientific documents for accuracy, formatting, consistency and compliance to protocols or SOPs.
Works with senior staff to determine approach for new assignments.
Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents.
Performs other duties as assigned.