Technical Writer (CMC)

Hello,

I hope you're doing well.

My name is Soundarya, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for 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

soundarya.kondra@intellectt.com

Job Title: Technical Writer (CMC)
Location:Los Angeles, CA
Work Arrangement: Onsite
Experience Level: 10-15 Years
Pay rate: $63/hr W2

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 withvalidation reports and CMC documentation.
• Strong scientific and technical writing background.
• Experience developing documentation templates.
• Experience reviewing or mentoring junior technical writers.

Preferred:

• Cell & Gene Therapy experience.
• Biologics regulatory submission experience.
• Experience mentoring/overseeing technical writers.

Benefits
Eligible employees may have access to benefits offered by Intellectt Inc., including medical, dental, vision, and other benefits, subject to eligibility requirements and applicable plan terms.

Intellectt Inc. is an Equal Opportunity Employer. We consider qualified applicants for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected by applicable law.

Thanks & Regards,
Soundarya
Technical Recruiter
Intellectt Inc

Soundarya@intellectt.com

Direct: 732 204 6899
Desk number: 732 412 6999 Ext: 247