About the Job

The Senior Project Manager, part of the Portfolio and Program Management Team, is responsible for the planning and execution of new biopharma clinical product development projects and/or lab expansion projects, as well as other business critical initiatives. The role manages multiple projects with competing timelines and interfaces with external biopharma partnerships. For each project, the role generates and executes project plans to deliver the defined solution business cases, as well as identifies and resolves resource requirements and issues pertaining to the designated projects. The position develops and manages project deliverables, and the programs and products worked by the incumbent may span from product concept initiation to global commercialization. 

Regular onsite work at a designated FMI location is an essential function of this role.

Key Responsibilities

• Project Management:
  • Lead project through the entire project management lifecycle, ensuring all project work is completed according to scope, schedule and budget
  • Ensures project resources are secured; project resource plans are managed to assure project is not delayed due to resource contention
  • Project risks are identified, prioritize and mitigated
  • Manage project scope change management
  • Develop and implement project plan, including cost, scope, schedule, risk, resource and communications plans.
  • Build team ownership and commitment to project plans.
  • Provide structured thinking to project team on overall approach and delegate tasks as appropriate.
  • Guide the team in appropriate decision-making through analyzing options and reviewing implications with the team. Make decisions pertinent to the project as needed.
• Communications and Reviews:
  • Responsible for team and cross-functional communications (written and oral).
  • Responsible for project related communications with external biopharma partners (written and oral).
  • Act as liaison between the project team and FMI governance (Portfolio Governance Committee and the Executive Team) as required.
  • Define and track key project metrics. Coordinate and guide project phase reviews on metrics.
  • Elevate critical business decisions to the appropriate committees, management teams or functional managers.
• Relationship Management:
  • Provide input to functional leaders on team and team member performance.
  • Develop and maintains strong relationships with functional leaders to drive success of projects and teams.
  • Influence cross-functional collaboration for the purpose of achieving optimal project outcomes.
  • Develop and maintain strong relationships with external biopharma teams to drive project success.
• Process Management:
  • Facilitate the Project Management Life Cycle (PMLC) at all stages. Derive from the process high quality, high impact deliverables of the project.
  • Leverage quality system use in project or product creation and continued compliance.
  • Actively review policy and practices pertinent to designated project for understanding of best practice and functional excellence. Implement improvements on an as needed basis.
  • Drive efforts to ensure cross-functional systems effectiveness.
• Team Management:
  • Lead a team of cross-functional representatives in the achievement of organizational goals.
  • Influence in a complex, matrixed environment, for optimal project outcomes.
  • Foster a team environment that enables all participants to contribute their full potential in pursuit of project objectives.
  • Monitor and ensure compliance with company policies and procedures (e.g., federal/country and regulatory requirements).
• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree
• 5+ years of work experience in a program or project management role

Preferred Qualifications

• Graduate Degree or advanced project management certification (PgMP, PMP)
• 7+ years of experience in a program or project 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
• 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
  • with Waterfall and Agile methodologies
  • working within deadline and resource constraints
  • managing program scope, roles and responsibilities, specifications, timelines, and resources
  • in a highly independent position
  • presenting and communicating with all levels of an organization, as well as with external customers
• Effective and clear communication and presentation skills
• 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.

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