About the Job
The Program Manager (PgMgr) is responsible for the development and management of a program or programs and/or including the planning and execution of new priority biopharma, clinical product(s) or other highly strategic business initiatives. The role generates and executes a program or project plan, delivers the defined solution business cases, and both identifies and resolves staffing and resource requirements and issues pertaining to assigned programs. The position is both creator and manager of project deliverables. For new products, the programs and products worked by the incumbent may span from product concept initiation to global commercialization.
· Lead project through the entire product development and/or project management lifecycle.
· Develop and implements program plan, including cost, scope, schedule, risk, and resources.
· Build team ownership and commitment to program plans.
· Provide strategic thinking to program team on overall approach and delegates as appropriate.
· Direct and mentor others on key program/project management processes.
· Lead the team in appropriate decision-making through strong judgment and the ability to analyze options and implications.
Communications and Reviews:
· Responsible for team and cross-functional communications (written and oral).
· Act as liaison between the program/project teams and FMI governance (Portfolio Governance Committee), product lifecycle teams, functional management and the Executive Team, as required.
· Lead project phase reviews and design reviews; defines and tracks key project metrics.
· Elevate critical business decisions to the appropriate stakeholders and/or functional managers.
· Provide input to functional leaders on team and team member performance.
· Develop and maintains strong relationships with functional leaders to drive success of program and teams.
· Influence cross-functional collaboration.
· Product Development Process (PDP) system knowledge through delivery of high quality and high impact deliverables. Program/project management lifecycle knowledge through delivery of high quality and high impact deliverables.
· Knowledge of FDA / ISO quality system use for the creation and continued compliance of products.
· Actively reviews policy and practice improvements to drive functional excellence.
· Influences cross-functional systems effectiveness.
· Financial management - budget, forecast, and strategic plan input and preparation.
· Continuous improvement of the product development process to optimize time to market.
· May lead a group or team of employees in the achievement of organizational goals.
· Guide, coach, direct, and develop direct reports, if applicable.
· Provide leadership through influence in a complex, matrixed environment.
· Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
· Direct control over activities and budget of one or more functional areas, product groups, projects/programs and/or operations.
· Monitor and ensure compliance with company policies and procedures (e.g., federal/country and regulatory requirements).
· Other duties as assigned
• Bachelor’s Degree
• 3+ years of work experience in a program management role
• Graduate Degree or advanced project management certification (PgMP, PMP)
• 5+ years of experience in a program management role
• Proficiency in program/project management skills and principles, including scope, schedule, resource and risk management
• Portfolio of leading international and/or distributed large scale product development projects utilizing project management and product design & development frameworks
• History of applying Waterfall and Agile methodologies
• Prior experience:
· with intercultural teams
· using project management tools
· involving FDA regulated products
· coordinating program details across disciplines and integrate all aspects of business as they impact development projects
· working within deadline and resource constraints
· managing program scope, roles and responsibilities, specifications, timelines, and resources
· in a highly independent position
· With projects that include a software component
• Effective and clear communication and presentation skills, and experience presenting and communicating with all levels of an organization as well as with external customers
• Demonstrated negotiation and conflict management skills
• Willingness to adapt and work in ambiguous and/or changing conditions
• Working knowledge of FDA, ISO, CLIA and CAP regulations
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI’s values: passion, patients, innovation, and collaboration
Internal applicants, please use your FMI email address.