Junior Project Manager

Insight Global; San Diego (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

Insight Global, within the biosciences sector, seeks a Project/Program Manager to plan and execute global regulatory registration and labeling transition programs. You will own workstreams across regions and product groups, coordinating Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, Supply Chain, IT, and regional teams.

You will translate requirements into actionable plans, maintain data accuracy, track milestones, escalate risks, and drive governance.

Qualifications

• Bachelor's degree in a relevant field.
• 4+ years of project or program management in a regulated environment.
• Experience with medical devices, in vitro diagnostics, biotech, pharma, or similar life-sciences.
• Experience developing and maintaining project plans, milestones, risks, issues, actions, and decisions.
• Familiarity with dossiers, design controls, quality systems, labeling, regulatory submissions, product registrations, or compliance remediation.
• Ability to coordinate deliverables across functions and drive timely follow-up in a matrix organization.
• Strong analytical and data-management skills to consolidate and validate information.

Responsibilities

• Lead assigned workstreams or execution packages with clear objectives, milestones, owners, dependencies, and target dates.
• Build and maintain detailed project plans aligned with integrated timelines across regulatory, labeling, quality, product, operations, and IT.
• Coordinate deliverables across functional and regional stakeholders; monitor commitments and drive closure in a matrix environment.
• Maintain risks, actions, issues, decisions, assumptions, dependencies; escalate schedule/resource/compliance concerns.
• Facilitate planning sessions, readiness reviews, and risk discussions; document decisions and owners.
• Coordinate technical dossiers and readiness reviews with SMEs; support submission-related dependencies.
• Maintain accurate product/registration data; reconcile inputs and resolve data issues.
• Prepare concise status updates and dashboards highlighting progress, milestones, risks, and support needs.

Skills

Integrated project planning

Cross-functional collaboration

Regulated life-sciences execution

Data-management

Governance & reporting

Excel proficiency

PowerPoint, Teams, SharePoint

Education

Bachelor's degree

Tools

Smartsheet

Microsoft Project

Job description

The Project/Program Manager will support planning and execution for global regulatory registration and labeling transition program within the Biosciences organization. The role will own defined workstreams, regions, product groups, or execution packages and coordinate activities across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, Supply Chain, Commercial, IT, and regional teams.

The Project/Program Manager will translate requirements into actionable plans, maintain accurate project data, track milestones and dependencies, drive follow-up, and escalate material risks or decisions through established governance. The successful candidate will combine strong execution discipline, data-management capability, attention to detail, and effective cross-functional communication.

MUST HAVES:

• Integrated project planning and scheduling using Smartsheet, Microsoft Project, or equivalent Advanced Excel and structured data management, including lookups, pivot tables, reconciliation, filtering, and data validation RAID and dependency management, including risks, actions, issues, decisions, assumptions, owners, and due dates Regulated life-sciences project execution, with working knowledge of regulatory submissions, technical documentation, design controls, QMS, or labeling Project reporting and governance, including milestone tracking, readiness reporting, dashboards, and concise status reporting

Key Responsibilities

• Lead assigned workstreams or execution packages, converting objectives into clear deliverables, milestones, owners, dependencies, and target dates.
• Build and maintain detailed project plans aligned with the integrated timeline, including regulatory, technical documentation, labeling, quality, product, operational, commercial, and IT activities.
• Coordinate deliverables across functional and regional stakeholders; monitor commitments, follow up on actions, and drive timely closure in a matrix environment.
• Maintain risks, actions, issues, decisions, assumptions, and dependencies; assess downstream impacts and elevate material schedule, resource, compliance, or scope concerns.
• Facilitate planning sessions, working meetings, readiness reviews, and risk discussions; document decisions, action items, owners, and due dates.
• Support technical dossier and documentation readiness by coordinating reviews, gap assessments, remediation activities, and submission-related dependencies with functional subject matter experts.
• Maintain accurate product, SKU, country, registration, naming, priority, lifecycle, and schedule information; reconcile inputs and resolve missing, duplicate, inconsistent, or outdated data.
• Prepare concise status updates and dashboards that highlight progress, upcoming milestones, overdue items, risks, dependencies, decisions, and required support.
• Ensure approved decisions and changes are reflected in plans, trackers, governance materials, and stakeholder communications.
• Identify practical opportunities to improve project controls, data quality, reporting consistency, and recurring workflows.

Required Qualifications

• Bachelor's degree in business, science, engineering, regulatory affairs, operations, information systems, or a related discipline.
• 4+ years of project or program management experience, including cross-functional project execution in a regulated environment.
• Experience supporting projects in medical devices, in vitro diagnostics, biotechnology, pharmaceuticals, or another regulated life-sciences environment.
• Demonstrated experience developing and maintaining project plans, milestones, dependencies, risks, issues, actions, and decisions.
• Working familiarity with one or more of the following: technical dossiers or files, design controls, quality systems, labeling, regulatory submissions, product registrations, documentation readiness, or compliance remediation.
• Experience coordinating deliverables across multiple functions and driving timely follow-up and accountability in a matrix organization.
• Strong analytical and data-management skills, including the ability to consolidate, reconcile, validate, and maintain information from multiple contributors.
• Strong Excel skills and proficiency with PowerPoint, Teams, SharePoint, and project-planning or collaboration tools.
• Strong organization, facilitation, written communication, and stakeholder-management skills.
• Ability to manage multiple priorities while maintaining accuracy, follow-through, confidentiality, and appropriate escalation.