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.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

Located at our Indianapolis, IN facility, the Warehouse Associate will be responsible for warehousing support related to domestic and international shipping and distribution of clinical trial and commercial products for RayzeBio programs.  In this role, the Warehouse Associate shall provide tactile support of all clinical trial and future commercial receiving, material handling, shipping and distribution activities for products manufactured internally at RayzeBio.  Associate will be responsible to learn Visual Inspection duties and complete them on a recurring basis.  Responsibilities also include supporting the implementation of the Supply Chain department procedures: logistics, warehousing, and materials management.  Additionally, Warehouse Associate will become one of the subject matter experts (SME) supporting compliance GXP and DOT regulations as required.

Job Responsibilities

• Execute labeling, packaging, and shipping of domestic and international shipments of internally manufactured radiopharmaceutical drug product programs.

• Assist with the scheduling of domestic and international shipments from RayzeBio.

• Execute the receipt of incoming materials.

• Execute the sampling and dispensing of materials in a cleanroom environment.

• Execute the physical activities related to the waste program.

• Execute activities related to the material cycle counting program.

• Execute the inspection of finished product prior to shipment.

• Provide tactile, hands-on support of logistics, warehousing, and materials management.

• Adhere to policies and standard operating procedures to ensure compliance with DOT and GXP regulations as required.

• Support the implementation of the Electronic Inventory System / ERP.

• Support the efforts to commercialize the distribution of current clinical programs upon FDA approval.

• Execute the day-to-day warehouse operations as assigned by the Warehouse Manager focused on KPIs to ensure compliance and operational control related to logistic and warehousing.

• Support the training of future Supply Chain team members.

• Ensure compliance with DOT, EH&S, Radiation Safety and GMP requirements as required.

Education and Experience:

• 5+ years of proven warehouse experience (2+ in a cGMP facility preferred).

• Domestic and international shipping experience, including knowledge of customs clearance and regulatory requirements for RAM shipments for ex-US countries.

• Radiopharmaceutical and DOT compliant shipping experience preferred.

• Demonstrated working knowledge of working in a cGMP warehouse environment preferred.

• Demonstrated experience with inventory control

Skills and Qualifications:

• Strong understanding of domestic and international shipping (Radiopharmaceutical experience preferred).

• Demonstrated knowledge in DOT, GMP, and NRC regulations

• Excellent professional ethics, integrity, and ability to maintain confidential information

• Highly motivated and organized professional with the ability to work under pressure while meeting corporate goals and objectives.

• The ability to perform daily work in a cleanroom environment with appropriate PPE.

#RayzeBio, #LI-Onsite

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.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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 adastaffingsupport@bms.com. Visit careers.bms.com/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.

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.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

The Document Control Specialist is responsible for the tactical oversight and maintenance of document control system for a new Radiopharmaceutical facility in Indianapolis, IN.  The Document Control Specialist will be a primary contact point for document control support.  This position will utilize quality assurance knowledge in maintaining the quality program to be ready for clinical development and GMP commercial operations.  Additional responsibilities may include providing support for corporate activities.

Job Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

• Manage the process for the creation, review, approval, and issuance of GxP controlled site documents and records including batch records, logbooks, forms, procedures, protocols, templates, and reports.

• Manage electronic document management system (EDMS) document lifecycle workflows and assignment of reviewers / approvers and training tasks.

• Review the format and metadata of new documents to ensure compliance with approved templates, procedures and EDMS requirements.

• Provide guidance to document initiators, owners, and users to ensure compliance with all applicable procedures / regulations and assist users with EDMS workflow related issues.

• Manage the periodic review of controlled documents and partner with document owners to ensure periodic reviews are completed within the required timelines.

• Coordinate and liaise with other departments to facilitate uniform quality standards for the site.

• Ensure that compliance to the training program is maintained and updated as needed.

• Process DCR packages and review for correctness and completeness; monitor and update in-process documents.

• Create, assign, and archive QA controlled lab notebooks and logbooks.

Education and Experience

·BS/MS in a Science related discipline preferred

·3-5 years of quality assurance experience

·Pharmaceutical and GMP experience preferred.

·Experience working with FDA or other federal and state regulatory bodies.

Skills and Qualification

·Highly motivated and organized professional with the ability to work independently.

·Working knowledge of 21 CFR Parts 11, 210, and 211

·Very personable with strong communication skills

·Excellent professional ethics, integrity, and ability to maintain confidential information.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. 

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

Work Environment

The noise level in the work environment is usually moderate.

#RayzeBio, #LI-Onsite, GPS_2025

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.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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 adastaffingsupport@bms.com. Visit careers.bms.com/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.

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.

Key Responsibilities

• The Global Trial Acceleration Associate is responsible for managing and executing on centralized activities in support of global trials with an emphasis on clinical documentation.

• The Global Trial Acceleration Associate will interact with clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitor (CTMo.), the study team and other functional areas within BMS and will provide support to the Study Team throughout the study duration (start-up, maintenance, and close-out of clinical studies).

• As the main point of contact for essential document management, ethical and regulatory submission-related activities, develops and maintains collaborative working relationships with relevant stakeholders.

• Support outsourcing activities by interfacing with operational teams, support groups and service providers for successful selection, contracting and execution of outsourced studies while ensuring compliance with regulatory standards, ethical practices, BMS outsourcing and procurement policies and procedures.

• Initiate and manage start-up documentation activities for global clinical trials.

• Submission of potential investigators to CTSS for debarment review and tracking of decisions.

• Responsible for country/Site Activation for clinical trials as applicable per region; this includes the final review of applicable documents, final sign-off of the country/site activation checklist. The incumbent may also be responsible for activating the site in accordance with all applicable global / local study procedures.

• May provide a level of quality control of start-up activity.

• Update and review of various study-related clinical systems to determine and report status of clinical trial documents for insourced studies (i.e., CTMS, eTMF, etc. or corresponding vendor systems)

• May arrange certified translation of study level documentation from translators as requested (i.e., ICF, Protocol, IB)

• May assist with the coordination or creation of other study specific materials such as pharmacy or Investigator site file to ensure that these are available on site for site initiation visits/prior to first patient visit.

• May act as single point of contact for the study team for centralized activities during study start-up.

• Ongoing maintenance and tracking of essential documentation and collection of updated/outstanding documentation and submission as required during all phases of clinical trial.

• Ongoing communication with study teams regarding centralized study activities.

• Maybe responsible for creation and management of standardized document templates.

• Assist with CSR distribution

• Country and site level ICF adaptation.

• Essential document collection, review and approval of country and site level documents.

• Centrally reviewing all the Site Monitoring Visit reports, issue escalation, resolution and follow up tasks.

• Other duties as assigned to support Clinical Trials.

Qualifications & Experience

• Minimum of a bachelor’s degree in legal, Life science, Business Administration, or equivalent experience. Advanced degree a plus.

• Minimum 3 years of relevant clinical development & operational experience in Pharmaceutical, biotech, CRO or similar fields, is required.

• Seasoned field monitor with min 3+ years of global site monitoring (Clinical Research Associate) report review experience is preferred.

• Prior therapeutic area expertise (eg: Oncology, Cardiology, Hematology, Immunology etc) is preferred.

• Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies; including formulating responses to queries.

• Hands-on experience of preparing, reviewing, and submitting clinical study start-up / activation documentation, including responses to queries.

• Knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma, Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals.

• Effective communication skills in English (written & oral), computer skills - MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred, knowledge of portals, databases and other Clinical Trial enabling technologies

• Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate.

• Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.

• Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.

• Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.

• Ability to sustain high levels of performance in a constantly changing environment.

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 adastaffingsupport@bms.com. Visit careers.bms.com/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.

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.

Shape the Future of Clinical Trials with Us

Join Our Global Development Team!

Are you ready to support the BMS portfolio and sets the strategic business direction? We’re seeking a passionate and experienced Senior Manager - Submission Management - Clinical Trials to support end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant clinical trial submissions for global health authorities and supporting continuous improvement initiatives. Position office based in Poland - Warsaw.

Position Responsibilities:

Regulatory Strategy & Submission

• Collaborate with global and local stakeholders to define clinical trial submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.

• Assess core submission deliverables to ensure compliance, prepare and distribute global CTA dossiers, and manage data required for EU CTIS and substantial modifications.

• Monitor and influence the regulatory assessment process, drive negotiations with stakeholders to resolve information requests, and communicate regulatory changes to ensure ongoing compliance.

• Manage and track queries, commitments, and submissions with health authorities, collaborate with subject matter experts for responses, and provide periodic status updates on commitments.

Continuous Improvement Initiatives

• Drive initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams.

• Contribute to the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information.

• Ensure consistency of Clinical Trial Applications across projects, studies, and countries, aligning with regulatory standards and best practices.

• Effectively communicate regulatory changes to the business to maintain compliance and support continuous improvement.

Team Leadership

• Lead a team of direct reports managing resource and  allocation and assigned projects, provide training and mentoring to new staff, and support team with development and innovation.

Education & Experience Requirements:

• Degree Requirements BA/BS degree, science / technology field preferred.

• 7+ years relevant regulatory submissions experience and people management experience.

Key Competency Requirements:

• Proficient knowledge of global regulatory practices, submission guidelines and requirements.

• Collaborates with key stakeholders and resolves cross-functional issues independently and generates solutions by weighing risks and dependencies.

• Support of other RISM members sharing expertise, providing guidance and serving as a SME.

• Communicates effectively in English and simplifies complex topics for presentations and workshops.

• Applies project management methodologies and strategic thinking to define objectives, track progress, and deliver results on increasingly more complex projects.

• Proficient with desktop software and able to instruct others.

Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.

Why Join Us?

• Be a key leader in global studies impacting diverse therapeutic areas.

• Work with talented teams across the US, India, Switzerland, and beyond.

• Grow your career in a supportive, forward-thinking environment.

• Make your mark in delivering high-quality, innovative clinical solutions.

Ready to take your leadership to the next level? Apply now and help us shape the next generation of Submissions Manager - Clinical Trials!

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

We kindly ask all applicants to send their CV in English.

#LI-Hybrid

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 adastaffingsupport@bms.com. Visit careers.bms.com/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.

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.

Summary:

At Bristol Myers Squibb, we are inspired by a single vision—transforming patients’ lives through science. Across oncology, hematology, immunology and cardiovascular disease, our colleagues advance innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Overview:
The Senior Business Analyst in the LIMS ELN and Entity Registration Platforms team will bridge scientific research needs and IT solutions, with a primary focus on Electronic Laboratory Notebooks/Laboratory Information Management Systems (ELN/LIMS) and the responsible adoption of Generative AI tools. This hands-on role partners with researchers, lab personnel, and IT to gather requirements, design solutions, and ensure effective implementation and support of ELN/LIMS capabilities, instrument connectivity, and GenAI-enabled workflows that improve data quality, speed of insight, and compliance.

If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!

Desired Candidate Characteristics

• Strong commitment to a career in technology with a passion for healthcare and impact on patients.

• Proven experience with ELN/LIMS in biotech/pharma research labs

• Degree in Biological or Chemical Sciences with prior hands-on research experience.

• Knowledge of molecular biology, antibody discovery, protein chemistry/biochemistry workflows and data management.

• Comfort translating scientific needs into system configurations, integrations, and training.

• Ability to work collaboratively with scientists, IT colleagues, vendors, and contractors.

• Demonstrated success operating within a matrixed organization and driving consensus.

• Strong focus on user experience, change management, and adoption.

• Excellent communication skills and agility to learn new tools and processes.

Key Responsibilities

• Requirements Gathering: Collaborate with scientists and lab managers to understand experimental workflows; document user needs, process maps, and data standards for ELN/LIMS and GenAI use cases.

• Solution Design: Partner with platform engineers and vendors to design configurations (schemas, registration models, templates, routing), integrations (APIs/webhooks/ETL), roles/permissions, and audit/traceability aligned with BMS standards.

• GenAI Enablement: Identify high-value GenAI opportunities (e.g., protocol drafting, experiment summarization, semantic search, assay troubleshooting assistants); define guardrails, evaluation, and privacy controls; support pilots through scale-up.

• Instrument & Data Connectivity: Coordinate instrument data capture, ensure metadata/FAIR practices, and support interoperability with analytics/warehouse environments.

• Delivery & Support: Manage backlogs and Jira boards; write user stories and acceptance criteria; plan and script UAT; develop training materials and conduct structured end-user training; provide post-go-live support.

• Compliance & Quality: Partner with QA/Validation as applicable (e.g., 21 CFR Part 11, GxP/CLIA contexts), ensuring documentation, change control, and audit readiness.

• Stakeholder & Vendor Management: Coordinate across Research, IT, Security, and vendors; contribute to roadmaps, SOWs, and service reviews to meet SLAs and continuous improvement goals.

Qualifications:

• Education: Bachelor’s or Master’s in Life Sciences (e.g., Molecular Biology, Biochemistry, Bioengineering) or related field.

• Experience: 3+ years as a Business Analyst (or Product BA) in life-sciences R&D; 3+ years configuring/implementing ELN/LIMS  ( Benchling, Genedata, Dotmatics, Revvity, Sapio etc.)

• GenAI: 1–2+ years enabling enterprise GenAI solutions (prompting/RAG, evaluation/guardrails, responsible use) for scientific knowledge or workflow assistance.

• Technical Skills: Familiarity with ELN/LIMS configuration, REST APIs/JSON, basic SQL; understanding of data models, ontologies, and controlled vocabularies.

• Analytical Skills: Ability to translate complex scientific requirements into testable specifications and measurable outcomes.

• Communication: Strong written/verbal skills for lab, IT, and leadership audiences.

• Regulatory Knowledge: Working understanding of 21 CFR Part 11, data integrity, and GxP/CLIA principles as applicable.

Preferred Qualifications:

• Hands-on system administration, including schema/registry design, workflows, templates, and data analysis configurations.

• Experience with instrument data capture and pipeline tooling; exposure to cloud analytics (e.g., Databricks/Snowflake/Power BI).

• Familiarity with vector search/embeddings and evaluation frameworks for GenAI; basic Python or notebooks for demos/data exploration.

• Professional certifications (CBAP/CCBA, CSPO/PSPO, PMP)

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.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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 adastaffingsupport@bms.com. Visit careers.bms.com/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.

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.

Key Responsibilities

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs
• Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
• Support the electronic submission preparation and review
• Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities
• Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers
• Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices
• Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors
• Independently leads and / or performs programming assignments with minimal supervision
• Support improvement initiatives

Minimum Requirements:

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• At least 5 years programming experience in industry recommended.
• Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs.
• Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database.
• Have worked on Japan/PMDA submissions, proficient in creating eSub package (aCRF, SDRG, define.xml)
• Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.
• Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
• Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
• Have good understanding of regulatory, industry, and technology standards and requirements.
• Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
• Demonstrated ability to work in a team environment with clinical team members.

Preferred Requirements:

• Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e.g. NDA, BLA, MAA)
• Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
• Experience in other software packages (e.g. R)
• Experience with the Linux operating system

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 adastaffingsupport@bms.com. Visit careers.bms.com/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.

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 Summary

Lead the authoring of clinical/regulatory documents in Japan.

The scope of clinical/regulatory documents includes clinical study reports (CSR) for local Ph 2 or 3 study, regulatory submission documents (CTD), briefing document for PMDA consultation, regulatory response documents, orphan drug designation.

• Lead the authoring of clinical/regulatory documents and support the performance goals (including quality and timeline) for the clinical development and regulatory submission in Japan as planned by the R&D Development Teams.
• Establish cross-divisional cooperative partnership with other functions according to the optimized and standardized processes and systems.
• Fulfill the role of Japan Documentation Lead.

Duties/Responsibilities

Play the following roles and take responsibilities at each phase in the life cycle of the BMSKK asset;

• Build the storyboard to author regulatory dossier policies and align with global team based on the information provided by DT.
• As DOC lead, understand the global authoring regulatory dossier strategy and lead the finalizing of domestic regulatory dossiers of clinical part.
• Set an appropriate and the shortest timeline to complete authoring regulatory dossiers and comply with the timeline.
• Propose to the team the optimal strategy for preparing regulatory submission documents based on the tendencies of each review division concerning the contents of PMDA review reports and inquiries.
• Complete the clinical modules with J-CDL/J-CS based on the storyboard.
• Manages and provides global submission materials to stakeholders as needed.
• Authoring and conducting a coordinating activity as CSR author.
• Take charge of the CSR authoring part in the inspection.
• Manage the operational execution by strategically using outsource vendors and ensure quality of deliverables.
• Comply with internal and external processes and guidelines.
• Review and edit other clinical/regulatory documents as required.
• Drive continuous process improvements by identifying and simplifying processes. Lead implementation of business process improvements based on information from collected metrics.
• Give advice to other scientific writers to help them improve their capabilities in creation of clinical/regulatory documents for Japan.
• Provide additional value by creating better collaborative work environment internally and externally to ensure that Japan team has a good communication with HQ counterparts as well as key stakeholders, such as clinical research and regulatory.

Qualifications

B.S. in medical / pharmaceutical / veterinarian / life-science area or three years or more experience in either pharmaceutical R&D industry is mandatory.

• PharmD/PhD/MD in a relevant scientific discipline, or MS/BS with a minimum of 3 years (MS) to 5 years (BS) in preparing regulatory submission documents or have equivalent credentials and experience.
• Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
• Good understanding of the tendency of each review department of PMDA regarding the contents of review reports and inquiries.
• Demonstrated ability required for strong writing skills both in Japanese and in English, preferably in authoring and leading the production of clinical/regulatory documents for submission to PMDA. Samples of required and experienced abilities are the followings:
• Capable of updating appropriately the first draft of M2.5.1 and M2.5.6 authored by J-CDL/J-CS and providing appropriate advice when authoring the first draft, or can prepare the first draft in collaboration with J-CDL/J-CS
• Capable of independently finalizing other clinical modules getting cooperation from R&D Development team.
• Also, capable of independently authoring the draft inquiry to regulatory regarding clinical matters.
• Experience in authoring the clinical part of the pre-JNDA/Eop2 consultation documents.
• Capable of communicating with the Global team about the contents/strategies of the authoring documents such as CTD module and the response to inquiries.
• Ability to analyze and interpret complex data from a broad range of scientific disciplines.
• Excellent organizational communication, facilitation and interpersonal skills in a cross-functional team.
• Demonstrated ability to manage timelines and keeping quality of work.
• Working knowledge of a document management system.
• Skills to appropriately manage CROs or translation vendors.
• Skills to read scientific documents in English and communicate with the global members both in English.

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 adastaffingsupport@bms.com. Visit careers.bms.com/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.

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.

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 adastaffingsupport@bms.com. Visit careers.bms.com/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.