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Documentation Specialist
3 weeks ago
Description
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Documentation Specialist
Contract: North Chicago, Illinois, US
Salary: $28.00 Per Hour
Job Code: 349225
End Date: 2024-06-08
Days Left: 18 days, 3 hours left
Apply
Responsibilities:
- Generate document templates for Analytical Development team.
- Draft reports to support Regulatory filings including IND and BLA dossiers.
- Develop and manage documentation procedures, including good documentation practices, handling and reviewing electronic laboratory notebooks, data and reports.
- Develop and maintain document management systems.
- Provide technical writing support for regulatory documents.
- Collaborate with project leaders and subject matter experts (SMEs) to incorporate feedback into drafting and editing of technical reports.
- Perform review and edits of the documents generated in Analytical Development.
- To be considered a BS degree in chemistry, biochemistry or a related area is required; a doctorate level education is preferred. 3 years of experience with technical publications in a regulated product development environment as a technical writer.
- Experience with writing and reviewing technical documentation.
- Experience with working in a GXP environment.
- Knowledge and experience with HPLC, LC-MS, CE and icIEF methods for biologic products is a plus.
- Knowledge and understanding of the development, commercialization, and life cycle management of biologic products.
- Strong organizational skills.
- Ability to establish relationships with other support areas to gather necessary information. Ability to work effectively in a team environment.
- Attention to detail Ability to work cross-functionally Ability to organize work to meet deadlines.
- Excellent interpersonal and oral/written communication skills, and advanced technical writing for submissions. Experience in regulatory filing and addressing health authority questions is a plus.
- Familiarity with MS Word, Excel, PowerPoint, Outlook and Acrobat.
- document
- documentation
- GMP
- GxP
- GDP
- MS Office
- Word
- File
- Excel
- PowerPoint
- Recruiter
- Phone
- Sanjay Rawat
- sanjay.rawat@collabera.com
Apply Now
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