Bristol Myers Squibb · 19 hours ago
Technical Writer
New Brunswick, NJ
Contract
Onsite
Entry, Mid Level
$41.29/hr - $44.29/hr
2+ years expBristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines. They are seeking a Technical Writer to deliver CMC documentation in support of the regulatory strategy for their Cell Therapy clinical portfolio, collaborating effectively across technical functions and managing timelines for submissions.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Hiring Manager
Somya Roy
Responsibilities
Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports
Plan and facilitate submission kick-off for clinical regulatory submissions across 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 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
Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process
Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections
Ensures content clarity/ consistency in messaging across 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 HA for submissions
Track upcoming submissions and ongoing submission progress
Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker
Represent Tech 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
Qualification
Required
Bachelors degree in Biology or related discipline with a minimum of 2 years experience
Cell therapy CMC experience required
Familiarity with eCTD structure for regulatory submissions is required
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 be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines
Take ownership of the section formatting, language check, connections to other sections / tables
Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy
Preferred
Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred
BLA experience is strongly preferred
Experience with computer-assisted document preparation tools is 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 (213)
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
2025-12-30
BioWorld Financial Watch
2025-12-29
2025-12-25
Company data provided by crunchbase