Documentation Specialist

3 weeks ago


North Chicago, United States Collabera Full time

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

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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.
Qualifications:
  • 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.
Job Requirement
  • document
  • documentation
  • GMP
  • GxP
  • GDP
  • MS Office
  • Word
  • File
  • Excel
  • PowerPoint
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Sanjay Rawat
  • sanjay.rawat@collabera.com


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