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
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