Program Manager, Global RA

Position Summary

Lead the overall global labelling strategy of critical labeling projects that supports the work-product and collaboration with cross-functional management as well as project steering committees, core teams, and stakeholders that achieves overall labeling project(s) goals and objectives. Strategic planning, collaboration, problem resolution, and implementation activities with the R&D, Manufacturing, Demand Planning, Logistics and Distribution, and International Regulatory leads and Business Unit representatives. Experienced with project management processes and can manage critical situations and provide mentorship and professional communication of project status to senior management as well as all team members.

Principal Responsibilities

• Lead/manage a team of project managers in local and remote positions globally specializing in label change management workstreams.
• Manage the strategic planning and implementation of labeling projects to a broad portfolio of medical devices with global compliance requirements, i.e. EU MDR, Legal Mfg Changes, Global Label Solutions, UKCA, Swis-exit, etc.
• Manage relationships with key stakeholders and project business owners (labelling functional teams, regulatory BU and commercial teams, manufacturing site leads, demand planning etc.)
• Communicate and report overall program/project status updates and progress.
• Manage Labeling Project Managers leading individual labeling workstreams within the scope of global labeling projects assigned.
• Knowledge and understanding of FDA 21 CRF 801, ISO 15223-1, MDR Regulation (EU) 2017/745) EU requirements. Keep abreast of updates/changes to global medical device regulations and communicate to key stakeholders impacts to Teleflex global labelling standards and work instructions.
• Mentor/coach/develop project managers with best practices and strong discipline in project leadership principles.
• Support the labeling project managers in planning, scheduling, and controlling activities to fulfill project scope and objectives by applying technical, theoretical, and managerial skills.
• Support the development and execution of integrated project plans that represents the appropriate level of label update details and interdependencies that align with project goal(s) within the overall global labelling program.
• Lead risk management strategies within scope to global labelling workstreams through implementation phase. Support labelling project managers in mitigation plans and activities as necessary.
• Present to executive leadership, steering committee members, and senior management monthly project and program status and escalate risks as necessary.

Education / Experience Requirements

• Bachelor’s degree in a business or technical discipline or equivalent education/experience required.
• Minimum 10 years’ experience in medical device or pharmaceutical labelling change management function.
• Minimum 5 years’ experience in new product development (NPD) in medical device or pharmaceutical industry.
• Minimum 10 years project management experience in large organizations with national and/or global operations in FDA and/or EU MDD regulated industry.
• Functional management experience with 5 direct reports in local and remote environment.
• Knowledge and application of disciplined project management processes.
• PMP, Scrum, and/or Six Sigma certification highly desired.

Specialized Skills / Other Requirements

• Strong skills in Project Management tools.
• Exceptional skills with MS Outlook, SharePoint, Excel, and Power Point presentation.
• Experience with Agile, SAP, Planview preferred.
• Exceptional interpersonal and leadership skills. Capable of leveraging these skills with a broad spectrum of audiences, ranging from functional SMEs to senior executive management.
• Technical aptitude and displayed ability to grasp general knowledge of multiple disciplines and technologies.
• Very strong competencies in strategic planning, project management, leadership, organization management, risk mitigation, tactical execution, and negotiation skills.
• Ability to produce and present clear, concise, and professionally written communications and presentations to senior executive management.
• Strong analytical capabilities and business acumen with superb relationship management skills.
• Ability to grasp strategic concepts and strategy development skills.
• Ability to lead and facilitate multiple activities and resources.
• Demonstrate strong work ethic, integrity, and professional conduct.
• Superior computer usage skills.