Regulatory Program Manager Jobs in Chicago, IL (NOW HIRING)

The Senior Program Manager has overall accountability for complex programs from concept through launch.

The Senior Program Manager is responsible to ensure the Core Team as well as the Extended Team is on track following the established IDCP / Project plan.

The Senior Program Manager is responsible for presenting issues, recommendations and updates to various governance bodies which consists of key decision makers, in regards to their programs.

The Senior Program Manager also assists in developing various product line strategies.

Position Responsibilities

• Provide leadership to cross-functional teams by defining clear, realistic goals; clear barriers to ensure team progress, and facilitate rapid decision-making.

• Manage internal and external business partners to achieve common objectives.

• Lead the program strategy development and Integrated Development and Commercial Plan (IDCP) / Project Plan at each stage gate to present to the various governance bodies. Generate analyses of timeline, resource, and budget information that facilitate scenario planning, contingency planning, risk assessment and decision-making.

• Facilitate the management of resources in alignment with approved IDCP / Project plan. Foresee and directly handle project resource issues. Proactively raise personnel issues, such as performance directly with functional management.

• Serve as a liaison with the various governance bodies, PDL, and the Core Project Team. The Senior Program Manager is expected to report team progress, highlight risks/returns, clarify issues, and suggest recommendations, and present next stage IDCP / Project plan.

• Organize and facilitate effective meetings. Identify and delegate action items, follow-up/track action items to resolution, update project plans & deliverables, and as required identify issues and ultimately resolve issues off-line (to ensure effective meetings at all levels).

• Responsible for developing and maintaining project budgets and providing project updates and information to support the financial reporting cycles.

• Monitors and tracks team performance metrics (time, cost and quality milestones) relative to endorsed project plan and prepares periodic management reports to communicate project performance.

• Collects, analyzes, integrates, and maintains cross-functional deliverables (i.e. Integrated Project Plans).

• Drives day-to-day Core Team activities to meet project milestones and keep functions on track.

• Understand critical path activities and anticipates steps that may be bottlenecks.

• Develops and executes communication plan to ensure effective and timely communication between the Core Team and functional management, senior management, governance bodies, and external partners.

Organizational Relationships

• Senior Program Manager is accountable to get the program started which includes identifying appropriate level of resources, gaining buy in from functional managers, setting up budgets, communicating key events and issues with recommendations and action plans.

• The Senior Program Manager is also accountable to the various governance bodies, Project Team and PDL for the project time lines, deliverables, and budget as defined in IDCP / Project plan.

• The Senior Program Manager has the authority to create cross-functional action plans, delegate tasks, and expect regular updates from functional team members with respect to their projects.

• The Senior Program Manager also is responsible to provide guidance to functional project team members to ensure goals are being met within the agreed upon IDCP / Project plan

Education And Experience

• The incumbent should have experience with product development processes by having a minimum 7 years as a Program Manager or two years' experience leading teams and 5 years as a project team member.

• Cross-functional experience across different areas such as R&D, Quality Assurance, Manufacturing Operations, Medical, Commercial, Clinical or Regulatory is preferred but not required.

• Fundamental knowledge of functions as related to their particular program assignments is essential.

• The incumbent should also have successfully demonstrated cross-functional leadership competencies (diligence, developing strategies, conflict-resolution, analysis, communication and business / organizational awareness) as well as project planning skills.

Technical Skills Requirements

• The incumbent should have a technical degree in a field that is related to the organizational needs of the particular unit assigned (i.e., drug, device, etc.).

• A bachelor's degree is a requirement and provided the incumbent has successfully demonstrated cross-functional project-planning and leadership skills, Masters degrees are not required, but are preferred.

• Formal Program Management training or certification preferred.

Physical Position Requirements

• The Senior Program Manager has full authority to act for the benefit of the project or program assigned within the agreed upon IDCP / Project plan.

• When conflicts across programs arise, the Senior Program Manager will try to resolve the conflict with his/her counterpart.

• If they cannot reach consensus, the conflict is elevated to the proper level for resolution.

• The Senior Program Manager has the authority and ability to manage internal and external business partners.

What is the minimum education experience required?

• The incumbent should have experience with processes by having a minimum 7 years as a Program Manager or two years' experience leading teams and 5 years as a project team member.

• Cross-functional experience across different areas such as R&D, Quality Assurance, Manufacturing Operations, Medical, Commercial, Clinical or Regulatory is preferred but not required.

• Fundamental knowledge of functions as related to their particular program assignments is essential.

• The incumbent should also have successfully demonstrated cross-functional leadership competencies (diligence, developing strategies, conflict-resolution, analysis, communication and business / organizational awareness) as well as project planning skills.

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