Artech Information System LLC Verified 36h ago
Regulatory Affairs Specialist V (5608050)
Swiftwater, PA, United States On-site
Salary not listedPaySalary not listed
TypeContract
Work settingOn-site
Verified listing
JobFig found this opening at its original source and checks that it remains available.
About the role
Candidate to author technical documents in Client's internal documentum system. Must have working knowledge of bacterial biologics and regulations pertaining to early and late phase pre-licensure activities. Must have working knowledge of GMPs and application to preparing clinical materials. Must be well-organized, work with minimal management and meet aggressive timelines. Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality. This position is working in the CMC area. Relevant experience is required
What you'll bring
- Must have working knowledge of bacterial biologics and regulations pertaining to early and late phase pre-licensure activities.
- Must have working knowledge of GMPs and application to preparing clinical materials.
- Must be well-organized, work with minimal management and meet aggressive timelines.
- CMC/ Regulatory writing experience