Day in Life- • Partner with a wide variety of functional areas to gather information required to maintain, update existing labeling, and track approved labeling and indications globally• Manage complex labeling-related programs, schedules, milestones, inter-dependencies, deliverables, and resources.• Oversee program teams and activities to meet business plan and quality requirements• Act as a focal point for and liaison to functional and program managers for planning, development, logistics, quality, etc.• Identify and/or participate in strategic cross-team or cross-functional initiatives and opportunities when appropriate. • Partner with wide variety of functional areas to gather information required to write accurate user instructions.• Work cross-team and cross-functionally to plan, budget, coordinate and manage programs, milestones, program priorities, and resources • Participate, or ensure team participation on, high-level product development team(s) as appropriate.• Coordinate/manage program team work with all related functional groups and outside contractors and suppliers • Serve as key communications contact with management to provide information on schedules, milestones, deliverables, etc., and to identify resource issues and needs• Ensure personal understanding of all quality policy/system items that are personally applicable.• Follow all work/quality procedures to ensure quality system compliance and high quality work.• Work with management and functional groups to ensure use of standard business processes and procedures to support compliance with federal and international regulations and industry standards.
Responsibilities may include the following and other duties may be assigned.
- Responsible for planning, initiating, monitoring, tracking and/or prioritizing internal and external communication projects and facilitating successful, on-time and within budget execution.
- Sets clear direction and management objectives that aligns with defined practices and policies and builds, protects and strengthens the credibility of the company among various internal and external stakeholders including the community, the public, government and regulatory authorities, shareholders and employees.
- Works closely with other departments, including but not limited to Marketing Communications, Graphic Design, Creative Media & Design, External Communications and Internal Communications to ensure high-quality content and execution.
- Directs day to day activities for multiple work-stream teams through managing project plans, resourcing, status reporting, resolving issues, identifying project risks and accountability for deliverables across multiple functional organizations.
- Establishes meaningful metrics and tracks against them.
- Responsible for project performance, risk management, administration, financial management, budgeting and issue resolution.
Must Have: Minimum Qualifications• BA/BS degree with 5+ years of program management experience; or a MA/MS with 3+ years of program management experience.
Nice to Have• 5+ years of job-related experience in a labeling creation environment or medical device industry• Experience leading business programs to completion• Demonstrated excellent people and communication skills (verbal and written)• Demonstrated strong organizational skills• Experience managing multiple programs successfully• Experience using electronic tools for managing programs, routing reviews and approvals, allocating resources, etc.• Proven ability to interact with a broad range of functional groups and individuals at various levels of the organization• Experience managing complex programs, especially electronic products, labeling, and/or medical devices• Experience in program resource coordination• 5+ years of experience in cross-functional, cross-geography program management• Experience working in a regulated environment• Experience working in an international organization• Management/supervisory experience• Experience working with cross-geography programs and teams• Experience working on programs requiring localization/translation