Quality - Technical writer

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

The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO). This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.

This role requires effective collaboration across technical functions to deliver on timelines for submissions. The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality, and Regulatory Sciences across CTDO. The successful candidate will work effectively in cross‑functional project teams to accomplish company goals.

Primary Responsibilities

• Co‑author scientific content for CTD Quality sections aligned with the regulatory strategy for clinical, commercial, and life‑cycle CMC submissions and for responding to health authority questions based on high‑quality technical reports.
• Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance with project timelines and CTD requirements.
• Provide input and scientific oversight for content generation for modules 2.3 and 3.
• Review and adjudicate comments, facilitate comment resolution, and revise draft sections.
• Ensure content clarity and consistency in messaging across the dossier.
• Represent technical writing and document management in cross‑functional CMC teams.
• Manage the logistical process and detailed timeline for scientific and regulatory content creation for clinical, commercial, and life‑cycle CMC regulatory submissions and for responding to health authority questions.
• Assist with dossier creation and system compliance for regulatory submissions.
• Coordinate with CMC matrix team leaders to ensure timely submissions.
• Support and implement continuous process improvement initiatives.
• Mentor and train employees on the technical writing processes.
• Collaborate with external suppliers for CTD content and review.
• Train others on procedures, system access, and best practices.
• Work independently under supervision and collaborate with other teams.
• Take ownership of section formatting, language check, and connections to other sections and tables.
• Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy, and the GPS organization.

Additional Responsibilities for Second Technical Writer Position

• Plan and manage logistics of regulatory submissions and facilitate submission kick‑off for clinical regulatory submissions across CTD pipeline assets.
• Set up a submission content tracker and work with the document specialist/PM/regulatory CMC to maintain it.
• Track upcoming submissions and monitor ongoing submission progress.
• Co‑author scientific content for CTD Quality sections in regulatory submissions across all pipeline assets.
• Review submission content and conduct comment‑resolution meetings for submissions.
• Ensure formatting and messaging consistency across different sections of the dossier.
• Coordinate response authoring, review, and data verification for queries from health authorities.
• Interact with and facilitate submission‑related meetings with CMOs.
• Represent technical writing and document management in cross‑functional team meetings.

Qualifications

• Bachelor's degree or equivalent in a relevant discipline with a 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; BLA experience strongly preferred.
• Outstanding verbal and written communication skills, strong attention to detail, planning, organizational, and negotiating skills, and demonstrated ability to deliver on time.
• Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PowerPoint) required.
• Experience with regulatory Documentum software (CARA, eSub, etc.) strongly preferred, and proficiency in compliance‑ready standards for final publication.
• Experience in biotech/pharma end‑to‑end product development required.
• Capable of working in a fast‑paced, changing team environment, prioritizing multiple tasks to meet filing deadlines.
• Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and its correlation to the authoring process.
• Can work independently under supervision and collaborate with other teams.