Co-op Jobs in Madison, NJ

At Bristol Myers Squibb, employees often ask, "Who are you working for?" That question drives collaboration, accountability, and urgency in our work. Our purpose-driven culture pushes us to discover, develop, and deliver innovative medicines for serious diseases.

Position Summary

GQ Brand Enablement Science & Technology is a function of the Global Quality (GQ) group. It supports Bristol Myers Squibb's global business units by improving brand performance and quality through science, data, and technology. The Commercial Specification Committee (CSC) is an integrated quality function within GQ-BEST. It sets up, maintains, and governs analytical controls and specification strategy for commercial drug products across the BMS global portfolio.

CSC works closely with Regulatory Affairs, Drug Substance and Drug Product Development, Manufacturing Science & Technology, Product Quality, and Commercial Operations. Together they make lifecycle decisions that protect product quality and patient safety from launch through post-approval.

Selected co-op candidates will join one of several cross-functional, multi-divisional teams that develop and execute Brand Enablement Science & Technology strategies.

Key Learnings

Learning areas depend on the position and may 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 to Friday, August 13, 2027.

Key Responsibilities

The co-op will help the CSC design and build digital tools that automate review of Justification of Specification (JoS) packages. These tools identify technical and regulatory gaps in proposed specifications so the CSC and stakeholders can reduce risk before Health Authority submission. Core work streams include:

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

• Support development of a digital tool or workflow that checks draft JoS packages against global regulatory guidance (e.g., ICH quality guidelines) and internal BMS regulatory intelligence. It flags specifications that may need revision, more data, or stronger justification.
• Help define the logic and criteria the tool uses, including what counts as a gap, how severity is scored, and how findings are shown to CSC reviewers.
• Test the tool against real and historical JoS packages, refine outputs based on reviewer feedback, and document how its assessments line up with known Health Authority precedent.

2. Regulatory Intelligence as a Model Input

• Compile, organize, and maintain a structured repository of historical Health Authority (HA) queries and responses related to product specifications.
• Analyze HA query and response data to find recurring themes and scientific rationale. Structure this intelligence so it feeds the automated review tool, not just a standalone reference.
• Write concise, traceable summaries of HA precedent to support the tool's logic and ad hoc CSC questions.

3. Specification Administrative Process Automation

• Support design and implementation of AI tools that streamline CSC administrative work, such as updating the meeting calendar, generating SharePoint pages, organizing documents and folders, and distributing meeting materials.
• Develop tracking tools (e.g., dashboards and trackers) and build automated reminder and notification systems that keep specification commitments and deadlines on track.

4. Specification Proposal & JoS Template Automation

• Support automation of standardized Specification Proposal and JoS templates, focusing on pre-filling data fields and reducing manual template work.
• Coordinate with the primary workstream so template automation feeds into the JoS review tool rather than duplicating it.

We hire for skills and capabilities, not just credentials. If this role excites you but does not perfectly match your resume, we encourage you to apply anyway.