Project/Program Management Specialist 2 - InVitro

Position Summary We are seeking an experienced Senior Project/Program Manager to support a major global regulatory registration and product transition program, along with other strategic integration initiatives within the Biosciences organization. The successful candidate will be a proactive, analytical project leader who can independently structure complex work, maintain reliable program data and reporting, and communicate effectively with project teams and senior stakeholders.

Our client, a leading Medical Device Manufacturing Company is looking for Project/Program Management Specialist 2 – InVitro and This is for an initial duration of 12 MonthsContract – Remote Role
 
Job Title: Project/Program Management Specialist 2 - InVitro
Job Id: 26-05217
Location: Remote Role
Duration: 12 Months Contract
Position Type: Hourly Contract Position (W2 only)

Job Description 

• On site preferred but for a stellar candidate we can do remote
• Senior Project/Program Manager (Contractor)
• Location: Milpitas, California preferred. Remote candidates may be considered based on experience and qualifications.
• Assignment Type: Temporary / Contract
• Department: Biosciences Integration PMO
• Reports To: Director, Integration Program Management

Technical Skills
Must Have 

• Integrated project planning: Ability to build and maintain detailed plans covering scope, deliverables, milestones, dependencies, owners, resources, and target dates.
• Regulated life sciences experience: Experience managing complex projects in medical devices, in vitro diagnostics, pharmaceuticals, or another regulated environment.
• Regulatory submission knowledge: Working knowledge of global product registrations, re-registrations, submission readiness, and regulatory documentation processes.
• Technical dossier management: Familiarity with dossier development, document readiness, review cycles, submission inputs, and approval dependencies.
• Quality and design control knowledge: Working knowledge of quality management systems, design controls, compliance requirements, and change control.
• Labeling and artwork project management: Experience coordinating labeling changes, artwork development, review and approval workflows, and implementation readiness.
• RAID and dependency management: Proficiency managing risks, actions, issues, decisions, assumptions, and cross-functional dependencies.
• Schedule and critical-path management: Ability to identify sequencing constraints, schedule conflicts, downstream impacts, and critical-path risks.
• Project data management: Experience designing and maintaining structured project databases, trackers, and reliable reporting processes.
• Advanced Microsoft Excel: Strong capability with formulas, pivot tables, lookups, data validation, reconciliation, and analysis.
• Power BI or comparable dashboard tools: Ability to develop and maintain dashboards that communicate milestones, overdue deliverables, risks, trends, and leadership actions.
• Project and collaboration tools: Proficiency with Microsoft PowerPoint, Teams, SharePoint, and project-planning platforms such as Smartsheet or Microsoft Project.

Nice To Have 

• Direct experience with global medical device or in vitro diagnostic product registrations and re-registrations.
• Experience coordinating technical dossier development, remediation, review, and submission readiness.
• Familiarity with labeling and artwork management systems, including review and approval workflows.
• Experience supporting quality management system, design control, change control, or compliance remediation initiatives.
• Experience managing product transitions, including dependencies across regulatory, quality, operations, supply chain, commercial, and IT teams.
• Experience supporting M&A integration, business transformation, or enterprise-level programs.
• Experience working with global teams across multiple regions, business units, and time zones.
• Working knowledge of Smartsheet, Microsoft Project, Microsoft Planner, or comparable project-planning tools.
• Experience with SharePoint-based data structures, document libraries, and program reporting.
• Experience automating reporting or workflows using Power Query, Power Automate, or comparable tools.

Position Summary 

• We are seeking an experienced Senior Project/Program Manager to support a major global regulatory registration and product transition program, along with other strategic integration initiatives within the Biosciences organization.
• Functional subject matter experts will own and perform the underlying regulatory, quality, technical, labeling, operational, commercial, and IT work. The Senior Project/Program Manager will integrate these activities into an executable plan, track progress, manage dependencies and risks, and drive timely decisions and accountability across the team.
• The successful candidate will be a proactive, analytical project leader who can independently structure complex work, maintain reliable program data and reporting, and communicate effectively with project teams and senior stakeholders.

Key Responsibilities 

• Lead assigned projects and workstreams, translating program objectives into clear scope, deliverables, milestones, owners, dependencies, and target dates.
• Build and maintain integrated project plans that align regulatory, technical documentation, labeling, quality, R&D, operations, supply chain, commercial, and IT activities.
• Coordinate across functional leaders and subject matter experts, monitor commitments, resolve planning gaps, and drive completion of deliverables in a matrix environment.
• Identify and manage risks, issues, actions, decisions, assumptions, schedule conflicts, and resource constraints.
• Assess the downstream impact of changes and delays, establish mitigation plans with accountable owners, and escalate material items through appropriate governance channels.
• Facilitate cross-functional planning sessions, working meetings, risk reviews, and decision discussions.
• Ensure meeting outcomes, approved decisions, and changes are reflected in project plans, reporting, and communications.
• Apply working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submissions to support appropriate planning, sequencing, documentation readiness, and submission readiness.
• Prepare concise status updates for project teams and leadership, highlighting progress, upcoming milestones, overdue actions, risks, dependencies, decisions, and required support.
• Design and maintain practical project databases, trackers, dashboards, and reporting processes.
• Consolidate information from multiple workstreams and analyze project data to identify trends, emerging risks, and areas requiring leadership attention.
• Improve the quality, consistency, and efficiency of program reporting, including opportunities to simplify or automate recurring data collection.

Required Qualifications 

• Bachelor's degree in business, science, engineering, operations, information systems, or a related discipline.
• Ten or more years of progressive project or program management experience.
• Experience managing complex, cross-functional projects or workstreams in a regulated life sciences environment.
• Demonstrated experience managing integrated plans, milestones, dependencies, risks, issues, decisions, and accountability across multiple functions.
• Working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submission processes.
• Strong analytical and data management capabilities, including experience developing project databases, dashboards, and data-driven reporting solutions.
• Advanced proficiency with Excel and strong proficiency with Power BI or a comparable data visualization tool.
• Proficiency with PowerPoint, Teams, SharePoint, and project planning or collaboration tools.
• Strong written, verbal, facilitation, presentation, and stakeholder management skills.
• Ability to influence and drive accountability without direct authority.

Preferred Qualifications 

• Direct experience supporting global medical device or in vitro diagnostic product registrations or re-registrations.
• Experience supporting regulatory submissions, technical documentation readiness, labeling transitions, or compliance remediation programs.
• Experience with business integration, transformation, M&A, or other enterprise-level initiatives.
• Experience working with global teams across multiple functions, regions, or business units.
• PMP, PgMP, or equivalent project management certification.

Core Capabilities 

• Independently structures ambiguous work and drives it to completion.
• Balances detailed workstream execution with broader program priorities and changing requirements.
• Translates project data into clear insights, decisions, and actions.
• Uses sound judgment in issue resolution, escalation, and prioritization.
• Manages multiple priorities effectively in a fast-moving environment.
• Maintains high standards for detail, data quality, and reporting accuracy.

Compensation: The hourly rate for this position is between $88.00-$93.00 per hour.

Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].

Qualified candidates please send your word format updated resume at the earliest to Pavan:

Pavan.p@sunrisesys.com

[732-395-4444].
 
Thank You.