Senior Technical Writer

Job Title: Technical Writer

Location: New Jersey (50 percent Onsite)

Duration: 6+ Months

We are seeking a CMC Regulatory Technical Writer with Cell Therapy experience to support clinical and regulatory submissions from early stage development through BLA registrational filings This is an excellent opportunity to work with a leading biotech organization and collaborate with cross functional teams driving innovative cell therapy programs

Key Responsibilities

• Author and review CMC documentation for CTD Modules 2.3 and 3
• Prepare regulatory dossiers and support eCTD submissions
• Coordinate submission timelines and manage documentation activities
• Collaborate with Process Development Analytical Development Technical Operations Quality and Regulatory teams
• Support responses to Health Authority questions and regulatory requests
• Ensure consistency accuracy and compliance of submission content
• Manage document tracking data verification and submission readiness
• Drive continuous process improvements and support document management best practices

Required Qualifications

• Bachelors degree in Biology or a related life sciences field
• 2 plus years of experience in biotech pharmaceutical regulatory documentation
• Hands on Cell Therapy CMC experience required
• Strong knowledge eCTD submissions and CTD structure
• BLA submission experience highly preferred
• Excellent technical writing communication and organizational skills
• Proficiency Microsoft Office Word Excel PowerPoint SharePoint