Bristol Myers Squibb · 2 hours ago
Documentation Analyst
United States
Contract
Remote
Mid, Senior Level
$35/hr - $41.80/hr
4+ years expBristol Myers Squibb is seeking a Documentation Analyst to manage documentation activities for marketing applications and regulatory submissions for cell therapy brands. The role involves collaboration with various departments to ensure compliance with regulatory guidelines and effective management of CMC submission documents.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
This role will be responsible for managing the documentation activities for marketing applications and/or post-approval regulatory submissions for cell therapy brands
This role may also require the preparation of some CMC dossier elements of regulatory filings for marketing applications and/or post-approval regulatory submissions for cell therapy brands
This position regularly interfaces with experts in Manufacturing Sciences & Technology, Analytical Sciences, Quality and Regulatory departments
This role requires effective collaboration and communication across the internal CCTM team and external department matrix teams to deliver quality regulatory submissions on time
This candidate is expected to have a good understanding of regulatory guidelines
Author independently CMC elements of regulatory filings
Provide technical writing expertise to ensure CMC submissions meet regulatory requirements and health authority expectations
Develop authoring plans and strategic approaches to filings with cross-functional teams
Carry out integrated review process for documents and lead the finalization of drafts for next phase review
Manage document preparation of CMC regulatory submission documents to client standards and ensure final document compliance to ensure submission content meets formatting requirements
Manage the logistical process in the authoring system for CMC regulatory submissions
This process includes coordinating reviews in the review and authoring system, assisting in the triage of comments, scheduling/facilitating consensus meetings, distributing review comments to the matrix teams
Facilitate data verification to ensure accuracy of submission data following the internal standard operating procedure
Participate on various cross-functional project teams, interact with technical subject matter experts, regulatory and other key partners both internal and external to the company as necessary
Qualification
Required
Bachelors degree in a relevant discipline with a minimum of 4 - 7 years relevant experience. OR a Masters degree with 1-3 years relevant experience
Must possess the ability to work both independently and collaboratively in a team environment and communicate effectively in all teams
Must possess excellent time management and organizational skills and have the ability to navigate in electronic systems
Must possess working knowledge of regulatory CMC submissions, experience in Cell Therapy and CMC are a plus
Must be highly flexible, and able to manage multiple projects in fast-paced, changing environment, and deliver on deadlines
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
2025-12-30
BioWorld Financial Watch
2025-12-29
2025-12-25
Company data provided by crunchbase