Bristol Myers Squibb is hiring: Technical Writer in New Brunswick

Job Overview

Duration: 12 months with possible extension
Pay Rate: $41.29 - $44.29/ hr on W2
Onsite: 50% required
Work Schedule: Mon-Friday (normal business hours)

Job Description

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. The 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 and works effectively in cross‑functional project teams.

Primary Responsibilities

• Co‑author scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life‑cycle CMC regulatory submissions.
• Plan and facilitate submission kick‑off for clinical regulatory submissions across the CTD pipeline assets.
• Manage the logistical process and detailed timeline for regulatory submissions.
• 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 Module 2.3 and 3.
• Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, and revise draft sections.
• Ensure content clarity and consistency in messaging across the dossier.
• Facilitate and manage the data verification process.
• Assist with dossier creation and system compliance for regulatory submissions.
• Coordinate response authoring, review, and data verification to queries from health authorities for submissions.
• Track upcoming submissions and ongoing submission progress.
• Maintain submission content tracker for regulatory submissions and update it in collaboration with document specialists, project managers, and regulatory CMC.
• Represent technical writing and document management in cross‑functional CMC teams as required.
• Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.
• Collaborate with external suppliers as needed for CTD content and review.
• Support and implement continuous process improvement ideas and initiatives.
• Train others on procedures, systems access, and best practices as appropriate.
• Mentor and train employees on the document management process.
• Work independently under supervision and collaborate with other teams.

Qualifications

• Bachelor’s degree in Biology or related discipline with a minimum of 2 years of experience.
• Cell therapy CMC experience required; familiarity with regulatory requirements and guidance pertaining to CMC documentation is preferred.
• 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.
• Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) required.
• Experience with computer‑assisted document preparation tools preferred along with proficiency in compliance‑ready standards for final publication.
• Experience in bio‑tech/pharma e2e product development required; capable of working in a fast‑paced, changing team environment, prioritizing multiple tasks to meet filing deadlines.

Travel

Occasionally to other local NJ sites for larger team meetings (2‑3 times a year).

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Writing/Editing and Information Technology

New Brunswick, NJ