Regulatory CMC Technical Writer, Cell Therapy

Bristol Myers Squibb; Summit (NJ); On-site; USD 75,000 - 95,000; Full time

Job summary

Bristol Myers Squibb is looking for a Technical Writer and Document Specialist in Summit, NJ, to support regulatory strategy for Cell Therapy clinical portfolios. This role demands effective collaboration across technical functions and management of CMC documentation for submissions.

Successful candidates will engage in various responsibilities including co-authoring scientific content, ensuring document clarity, and mentoring. Expertise in eCTD structure and 2+ years of related experience preferred.

Qualifications

• Minimum of 2 years of experience (4-7 years for senior level).
• Cell therapy CMC experience required.
• Familiarity with eCTD structure for regulatory submissions required.

Responsibilities

• Co-author scientific content for CTD Quality sections aligned with regulatory strategy.
• Manage logistical processes for scientific and regulatory content creation.
• Collaborate with external suppliers for CTD content and review.

Skills

Outstanding verbal and written communication skills

Strong attention to detail

Planning and organizational skills

Negotiating skills

Education

Bachelor's degree or equivalent in a relevant discipline

Tools

Microsoft Office applications (Word, Excel, SharePoint, PowerPoint)

Regulatory Documentum software (CARA, eSub, etc.)

Job description

Bristol Myers Squibb is looking for a Technical Writer and Document Specialist in Summit, NJ, to support regulatory strategy for Cell Therapy clinical portfolios. This role demands effective collaboration across technical functions and management of CMC documentation for submissions.

Successful candidates will engage in various responsibilities including co-authoring scientific content, ensuring document clarity, and mentoring. Expertise in eCTD structure and 2+ years of related experience preferred.