Senior Technical Writer

United Consulting Hub; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

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

Location is New Jersey with 50 percent onsite work. You will author and review CTD Modules 2.3 and 3, prepare regulatory dossiers, coordinate

Qualifications

• BS in Biology or related life sciences required.
• 2+ years of biotech/pharma regulatory documentation experience.
• Hands-on Cell Therapy CMC experience required.
• Strong knowledge of eCTD submissions and CTD structure.
• BLA submission experience is highly preferred.
• Excellent writing, communication and organizational skills.

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.

Skills

Technical writing

Communication

Organizational skills

Education

Bachelor's degree in Biology or related life sciences

Job description

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