Spec 2, Project/Program Mgmt

Lancesoft; Milpitas (CA); Remote; USD 120,000 - 170,000; Full time

Job summary

Lancesoft is seeking a Senior Project/Program Manager (Contractor) to lead a major global regulatory registration and product transition program within the Biosciences organization. The role requires coordinating regulatory, quality, labeling, and IT work, integrating activities into executable plans, tracking progress, and driving timely decisions across teams.

The ideal candidate has 10+ years of PM/Program experience in regulated life sciences, PMP or PgMP is preferred, and must be adept with

Qualifications

• Bachelor's degree in business, science, engineering, operations, information systems, or related field.
• 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.
• Working knowledge of technical dossiers, design controls, labeling, quality systems, and regulatory submission processes.
• Strong analytical and data management capabilities, including dashboards and data-driven reporting.
• Advanced proficiency with Excel and Power BI or comparable data visualization tool.

Responsibilities

• Lead projects and workstreams translating objectives into scope, milestones, owners and dependencies.
• Build integrated plans aligning regulatory, technical docs, labeling, quality, R&D, ops, supply chain, commercial, and IT activities.
• Coordinate across functional leaders, monitor commitments, drive deliverables in a matrix environment.
• Identify and manage risks, issues, actions, decisions, assumptions, schedule conflicts, and resource constraints.
• Facilitate cross-functional planning sessions, risk reviews, and decision discussions.
• Ensure meeting outcomes and changes reflected in plans and reports.
• Prepare concise status updates for teams and leadership highlighting progress and risks.
• Design and maintain project databases, trackers, dashboards, and reporting processes.

Skills

Integrated planning

Regulated life sciences

Regulatory submissions

Dossier management

Quality and design controls

Labeling coordination

RAID management

Schedule management

Data management

Advanced Excel

Power BI dashboards

PowerPoint / Teams / SharePoint

Education

Bachelor's degree in a related discipline

Tools

Smartsheet

Microsoft Project

Power BI

Excel (Advanced)

SharePoint

Job description

Title: Senior Project/Program Manager (Contractor) Duration: Oct 30, 2026 Oct 29, 2027 Location: Milpitas, CA 95035 preferred. Remote candidates may be considered based on experience and qualifications Schedule: Pst hours Preferred at least 10 years experience Experience with Acquisitions and Mergers, working with large global teams . PMP certification Experience with Product Registration, Labeling and Regulatory Submissions,

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 escal…
• 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.