Project/Program Mgmt Spec 2

LanceSoft • Milpitas, CA

5d

About The Position

The Senior Project/Program Manager will support a major global regulatory registration and product transition program, as well as other strategic integration initiatives within the Biosciences organization. Functional subject matter experts own and perform the underlying regulatory, quality, technical, labeling, operational, commercial, and IT work. The manager integrates these activities into an executable plan, tracks progress, manages dependencies and risks, and drives timely decisions and accountability across the team.

The successful candidate is 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. The role is based in Milpitas, California, with onsite work preferred; remote candidates may be considered based on experience and qualifications. This is a temporary contract assignment within the Biosciences Integration PMO and reports to the Director, Integration Program Management.

Requirements

• 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.
• Ability to independently structure ambiguous work and drive it to completion.
• Ability to balance detailed workstream execution with broader program priorities and changing requirements.
• Ability to translate project data into clear insights, decisions, and actions.
• Sound judgment in issue resolution, escalation, and prioritization.
• Ability to manage multiple priorities effectively in a fast-moving environment.
• High standards for detail, data quality, and reporting accuracy.

Nice To Haves

• 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.

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 aligning regulatory, technical documentation, labeling, quality, R&D, operations, supply chain, commercial, and IT activities.
• Coordinate functional leaders and subject matter experts, monitor commitments, resolve planning gaps, and drive deliverable completion in a matrix environment.
• Identify and manage risks, issues, actions, decisions, assumptions, schedule conflicts, and resource constraints.
• Assess downstream impacts 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 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 simplifying or automating recurring data collection.

What This Job Offers

• Career Level: Senior