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    Documentation Specialist - North Chicago, United States - Collabera

    Collabera
    Collabera North Chicago, United States

    3 weeks ago

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    Description
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    3. Job Description
    Documentation Specialist

    Contract: North Chicago, Illinois, US

    Salary: $28.00 Per Hour

    Job Code:

    End Date:
    Days Left: 10 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.
    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
    Apply Now
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