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Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

**Position:** Senior Manager, Cell Therapy Technical Writing & Document Management

**Location:** New Brunswick / Warren / Princeton Pike (NJ)

Position Summary:

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. The role will be responsible for technical writing and document management.

This role requires effective collaboration across technical functions to deliver on timelines for submissions and accomplish company goals. The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences across CTDO.

Key Responsibilities:

+ Co-author/author 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 CMC modules

+ Review and adjudicate comments, facilitate comment resolution, revise draft sections

+ Ensure content clarity & consistency in formatting and messaging across 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 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

+ Technical writing and document management support across lifecycle of the asset

+ Collaborate with external suppliers as needed for CTD content and review

+ Manage data verification documentation

+ Mentor and train employees on the technical writing processes, systems access and best practices as appropriate

+ Work independently under supervision and collaborate with other teams

+ Setup and track submission content tracker for regulatory submissions and work with Documentation Specialist/PM/Regulatory CMC to maintain tracker

+ Coordinate response authoring, review and data verification to queries from HA for submissions

+ Manage submission, preparation of HA meetings, briefing books, IRs and other critical documents writing

+ Management of CTD book of work of submissions, prioritization, contractor management to align integrated overview of all submissions across CTD

Education & Experience :

+ Bachelor's degree or equivalent in relevant discipline with a minimum of 5 years' direct experience in managing Cell Therapy technical writing and document management

+ Cell therapy CMC experience required

+ Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process

+ 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 with regulatory documentum software (CARA, eSub, etc.) is strongly preferred along with proficiency in compliance ready standards for final publication

+ Experience in biotech/pharma e2e product development required

+ Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines

+ Demonstrated ability to work independently under supervision and collaborate with other team members from scientific functions, project management, and document management

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

**Company:** Bristol-Myers Squibb

**Req Number:** R1592221

**Updated:** 2025-05-28 04:26:39.301 UTC

**Location:** Princeton-NJ

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.