Technical Writer – GMP
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Wisconsin • United States
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About the role
- 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.
- 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.
- 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.
- Works with senior staff to determine approach for new assignments.
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
- Ability to work well in a collaborative team environment
Benefits
- Standard work schedule (Mon-Fri)
- Comprehensive background check including drug screening
- Opportunities for career development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
scientific document preparationanalytical methods writingreport writingprotocol developmentdata compilationquality control reviewSOPsanalytical laboratory procedureseCTD complianceregulatory submission
Soft Skills
collaborative teamworkattention to detailcommunicationproblem-solvingorganizational skills
Certifications
Bachelor's degreevocational qualification