Senior Technical Writer (CMC)

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.