2027 Spring Co-op Global Quality - Commercial Specification Committee

Regulatory Jobs; Madison (NJ); On-site; USD 39,000 - 41,000; Full time

Job summary

Bristol Myers Squibb in Madison, NJ offers a co-op with the Global Quality - Commercial Specification Committee. You will help build digital tools to automate JoS reviews, analyze regulatory inputs, and support automation across CSC.

This internship develops skills in regulatory science, data analytics, and cross-functional teamwork. The role emphasizes compliance with ICH standards and Health Authority precedents, with a focus on quality and patient safety.

Qualifications

• Currently enrolled in a Bachelor's degree program with GPA ≥3.0
• Pursuing CS, Data Science, Regulatory Affairs or Digital/Tech
• Strong analytical and data skills (Python, Excel)
• Excellent written and verbal communication
• Authorized to work in the US for duration of employment

Responsibilities

• Design & build digital tools to automate JoS review workflows
• Define logic and criteria the tool uses to assess specifications
• Test tools against JoS packages and align outputs with Health Authority precedents
• Maintain a structured knowledge repository of HA queries and responses
• Develop dashboards and trackers to monitor CSC activities
• Automate Specification Proposal and JoS templates to pre-populate data fields

Skills

Python

Excel

Data analysis

Education

Bachelor's degree in CS/Data Science/Regulatory Affairs or related

Tools

SharePoint

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

GQ Brand Enablement Science & Technology is a function of the Global Quality (GQ) group that serves Bristol-Myers Squibb's global business units by advancing brand performance and quality excellence through the integration of innovative science, data, and technology solutions. The Commercial Specification Committee (CSC) is an important and integrated quality function within GQ-BEST, responsible for establishing, maintaining, and governing the analytical controls and specifications strategy for commercial drug products across BMS's global portfolio. CSC plays a critical role in bridging science, regulatory requirements, and manufacturing quality standards — ensuring that product specifications are scientifically sound, compliant with global regulatory frameworks, and aligned with the evolving needs of patients, markets, and business stakeholders. Through cross-functional collaboration with Regulatory Affairs, Drug Substance and Drug Product Development, Manufacturing Science & Technology, Product Quality, and Commercial Operations, CSC drives lifecycle management decisions that safeguard product quality and patient safety from launch through post-approval.

CSC enhances the colleague and customer experience by delivering the right insights, tools, and capabilities at the right time — in the most efficient and effective way. Strategic solutions aimed at optimizing end-to-end brand enablement capabilities, and which align to where our stakeholders and customers are evolving, are critical in ensuring the highest levels of quality and innovation in what is a rapidly changing environment.

The candidate(s) chosen for this position will become valued team members of one of several cross-functional, multi-divisional teams responsible for developing and executing Brand Enablement Science & Technology strategies for Bristol-Myers Squibb.

Key Learnings will be based on the position and can include

Pharmaceutical analytical controls strategy and specification lifecycle management; regulatory science principles (ICH quality guidelines); applied data analytics and automation tool development (e.g., Python, structured data pipelines, AI-assisted document review); Digital & Technology Innovation; Communications and Quality Systems operations.

Program Dates

Monday June 7, 2027 - Friday, August 13, 2027.

Location

Madison, NJ (Giralda Farms)

Key Responsibilities

The Co-op will support the Commercial Specification Committee (CSC) by helping design and build digital tools that automate the review of Justification of Specification (JoS) packages — identifying technical and regulatory gaps in proposed specifications so CSC and stakeholders can proactively mitigate risk ahead of Health Authority submission. Core work streams include:

1. JoS Review Automation & Gap Analysis (Primary Focus)

• Support the development of a digital tool/workflow that evaluates draft JoS packages against global regulatory guidance (e.g., ICH quality guidelines) and internal BMS regulatory intelligence, flagging specifications that may require revision and/or additional data or stronger justifications

• Help define the logic and criteria the tool uses to assess a specification package — what counts as a gap, how severity is scored, and how findings are presented to CSC reviewers

• Test the tool against real and historical JoS packages, refine outputs based on reviewer feedback, and document how the tool’s assessments align with known Health Authority precedent

2. Regulatory Intelligence as a Model Input

• Compile, organize, and maintain a structured knowledge repository of historical Health Authority (HA) queries and corresponding responses related to product specifications

• Analyze HA query/response data to identify recurring themes and scientific rationale, structuring this intelligence so it can be used as an input to the automated review tool (not just a standalone reference)

• Develop concise, traceable summaries of HA precedent to support both the tool’s logic and ad hoc CSC questions

3. Specification Administrative Process Automation

• Support the design and implementation of automated AI tools to streamline CSC administrative processes, including update meeting calendar, SharePoint page generation, document and folder organization, and distribution of meeting materials

• Develop tracking tools (e.g., dashboards, trackers); Build automated reminder and notification systems to ensure timely follow-through on specification-related commitments and deadlines

4. Specification Proposal & JoS Template Automation

• Support automation of standardized Specification Proposal and JoS templates, focused on pre-populating data fields and reducing manual template-filling effort

• Coordinate with the primary workstream so template automation feeds into, rather than duplicates, the JoS review tool

Qualifications & Experience

• Currently enrolled in a Bachelor’s Degree program with a minimum GPA 3.0; student must be enrolled in school the semester prior to the co‑op.
• Seeking candidates pursuing an undergraduate degree in Computer Science, Data Science, Regulatory Affairs/Regulatory Science, or a Digital/Technology discipline.
• Must have strong analytical and data analysis skills (e.g., Python, Excel/data tools) and the ability to translate regulatory guidance into structured logic, plus excellent written and verbal communication skills.
• Must be highly organized and can work in teams in a matrixed environment.
• All candidates must be authorized to work in the US both at the time of hire and for the duration of their employment. Please note that immigration or visa sponsorship is not available for this position.

Compensation Overview

$28 - $30/hr

Pay for this internship/co‑op position is provided in accordance with local market practices and applicable laws. Pay may be offered as an hourly rate and/or monthly stipend, or other locally compliant structure. Pay is determined based on objective factors such as academic level, relevant experience, skills, and work location.

Interns and co‑op participants may be eligible for limited benefits depending on program structure, work location, and local requirements. Eligibility and offerings are governed by applicable policies and employment regulations.

This is a temporary, time‑bound position intended for the duration of the internship or co‑op program and does not guarantee continued or permanent employment following program completion.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

For roles based in Los Angeles County only: 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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607361 : 2027 Spring Co-op Global Quality - Commercial Specification Committee