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Senior Technical Writer (CMC)

Intellectt INC

  • Los Angeles, CA
  • 18 days ago

    Highlights

    Skills: CMC Technical Writing, Pharma/Biotech Documentation, Regulatory Filings, Late-Stage Development, Validation Reports, CMC Documentation, Scientific & Technical Writing, Documentation Templates, and Technical Writer Mentoring/Review. Our client is seeking an experienced Senior CMC Technical Writer to support a growing Cell Therapy organization through late-stage development and regulatory submission activities.

    Numbers & Facts

    LocationLos Angeles, CA

    Description

    Hello,

    I hope you're doing well.

    My name is Rudra, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for Senior Technical Writer (CMC) based in Los Angeles, CA with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at prasad.kunnath@intellectt.com

    Job Title: Senior Technical Writer (CMC)
    Location: Los Angeles, CA
    Work Arrangement: Remote
    Experience Level: 3 5 Years
    Pay rate: $50-$63/hr on W2

    Skills: CMC Technical Writing, Pharma/Biotech Documentation, Regulatory Filings, Late-Stage Development, Validation Reports, CMC Documentation, Scientific & Technical Writing, Documentation Templates, and Technical Writer Mentoring/Review.

    Job Description:
    Our client is seeking an experienced Senior CMC Technical Writer to support a growing Cell Therapy organization through late-stage development and regulatory submission activities.

    Key Responsibilities:

    • Prepare and review CMC technical and regulatory documents.
    • Support late-stage development and marketing authorization submissions.
    • Prepare and review validation reports and related CMC documentation.
    • Develop standardized technical documentation templates.
    • Work independently with scientific and technical teams.
    • Review work completed by junior technical writers.
    • Provide guidance and oversight to junior writers.

    Required Skills:

    • Extensive CMC technical writing experience in Pharma/Biotech.
    • Experience supporting late-stage development and regulatory filings.
    • Experience with validation reports and CMC documentation.
    • Strong scientific and technical writing background.
    • Experience developing documentation templates.
    • Experience reviewing or mentoring junior technical writers.

    Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

    Equal Employment Opportunity: Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

    Thanks & Regards,

    Kunnath Rudra Prasad
    Technical Recruiter
    Intellectt Inc
    prasad.kunnath@intellectt.com
    Direct: 732 200 2726
    Desk number: 732 200 2726 Ext: 189

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