Senior Technical Writer (CMC)

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. My name is Uzma Kousar Mohammed, and I m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Senior Technical Writer (CMC) based in Los Angeles, CA with one of our prestigious clients.

Hello,

I hope you're doing well.

My name is Uzma Kousar Mohammed, and I m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a 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

uzma.kousar@intellectt.com

Job Title: Senior Technical Writer (CMC)
Location: Los Angeles, CA Remote
Pay Rate: $50/hr - $60/hr on W2
Industry: Pharmaceutical / Biotechnology

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.

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. 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,
Uzma Kousar Mohammed
Technical Recruiter
Intellectt Inc

uzma.kousar@intellectt.com

Direct: 732 993 4997
Desk number: 732 412 6999- Ext: 139