Bristol Myers Squibb · 1 day ago
Quality - Technical writer
Warren, NJ
Contract
Hybrid
Mid, Senior Level
$45/hr - $48.72/hr
2+ years expBristol Myers Squibb is a leading biopharmaceutical company, and they are seeking a Quality - Technical Writer to support the regulatory strategy for their Cell Therapy clinical portfolio. This role involves delivering CMC documentation and requires effective collaboration across various technical functions to meet submission timelines.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Co-authors/authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical, commercial, and life-cycle CMC regulatory submissions and responses 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 to project timelines and aligned with CTD requirements and regulatory strategy
Provide input and scientific oversight for content generation for module 2.3 and 3
Review and adjudicate comments, facilitates comment resolution, revises draft sections
Ensures content clarity/ consistency in messaging across dossier
Represent Tech 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 responses 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 ideas and initiatives
Mentor and train employees on the technical writing processes
Collaborate with cross-functional team for effective logistical process and detailed timeline for scientific/ regulatory content creation for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions
Assist with dossier creation and system compliance for regulatory submissions
Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process
Manage the logistical process and detailed timeline for authoring, review and data verification of regulatory submissions
Collaborate with external suppliers as needed for CTD content and review
Manage data verification documentation
Review and adjudicate comments in collaboration with SMEs
Train others on procedures, systems access and best practices as appropriate
Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process
Work independently under supervision and collaborates with other teams
Qualification
Required
Bachelors degree or equivalent in relevant discipline with a minimum of 2 years experience (4-7 years for senior level)
Cell therapy CMC experience required
Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred
Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery
Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required
Experience in bio tech/pharma e2e product development required
Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process
Work independently under supervision and collaborates with other teams
Preferred
BLA experience is strongly preferred
Experience with regulatory documentum software (CARA, eSub, etc) is strongly preferred along with proficiency in compliance ready standards for final publication
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-18
2026-01-16
Company data provided by crunchbase