Regulatory CMC Technical Writer – Cell Therapy

Bristol Myers Squibb; Milltown (NJ); Hybrid; USD 52,348 - 57,804; Full time

Benefits offered by this job

Comprehensive ACA-compliant health coverage

Dental and vision benefits

401(k) plan

Referral bonus program

Job summary

A leading biopharma company in New Jersey is seeking a Technical Writer and Document Specialist to support regulatory submissions for a late-stage clinical cell therapy program. Responsibilities include co-authoring scientific content, managing submission logistics, and ensuring document clarity. Candidates should have a Bachelor's degree in Biology and experience in regulatory documentation. This role requires effective collaboration across technical teams and offers a contract position with a starting hourly rate of $38 to $41.96, with 50% onsite work required.

Qualifications

• Minimum 2 years of experience; 4–7 years for senior level.
• Familiarity with regulatory requirements for CMC documentation.
• Experience in biopharma end-to-end product development required.

Responsibilities

• Co-author scientific content for regulatory submissions.
• Manage logistics for regulatory submissions.
• Collaborate with SMEs on submission documents.

Skills

Outstanding verbal and writing communication skills

Strong attention to detail

Organizational and negotiating skills

Proficiency in Microsoft Office applications

Education

Bachelor’s degree in Biology or related discipline

Tools

eCTD structure for regulatory submissions

Computer-assisted document preparation tools

Job description

A leading biopharma company in New Jersey is seeking a Technical Writer and Document Specialist to support regulatory submissions for a late-stage clinical cell therapy program. Responsibilities include co-authoring scientific content, managing submission logistics, and ensuring document clarity. Candidates should have a Bachelor's degree in Biology and experience in regulatory documentation. This role requires effective collaboration across technical teams and offers a contract position with a starting hourly rate of $38 to $41.96, with 50% onsite work required.