2027 Spring Co-op Global Quality - Commercial Specification Committee
About the role
Key Learnings will be based on the position and can include
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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:
- 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
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Currently enrolled in a Bachelor’s Degree program with a minimum GPA 3.0; student
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