About the Job

The Project Manager, R&D 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. Responsibilities include development and execution of project plans to deliver a defined solution business case, identification and resolution of project resource requirements and issues, and developing and managing project deliverables. The programs and products the incumbent works on spans from product concept initiation to global commercialization. This position does not have any direct reports.

Key Responsibilities

• Develop the project plan, including scope, schedule, risk, resource, and communications plans for projects.
• Build team ownership and commitment to project plans.
• Provide a structure, a conceptualization of the implementation process and outcomes to project team on overall approach.
• Delegate sections of project work.
• Leverage Voice of Customer, Voice of Business, and personal accountability to initiatives on unyielding commitment to results.
• Guide the team in appropriate decision-making through strong judgment and the ability to analyze options and implications.
• Act as a liaison between the team and FMI governance (Portfolio Governance Committee, Executive Team and other governing organizations).
• Coordinate and guide project phase reviews that define and track key project metrics.
• Elevate critical business decisions to the appropriate committees, management teams and/or functional managers.
• Provide input to functional leaders on team and team member performance.
• Initiate regular communication with functional leaders at set intervals on the topic of the success of projects and teams.
• Provide cross-functional collaborative consultation to teams and groups.
• Initiate policy and practice improvement efforts to drive functional excellence.
• Periodically mentor team members with less years of experience to contribute to and support their full potential in pursuit of project objectives.
• Monitor and ensure compliance with company policies and external regulations (e.g. state, federal or country requirements), in particular during project launch activities.
• Other periodic projects and duties pertinent to project management as assigned.

Qualifications:

Basic Qualifications:

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

Preferred Qualifications:

• Graduate Degree or advanced project management certification (PgMP, PMP)
• 3+ 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
• Experience using Smartsheet software
• 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: Integrity, Courage, Passion

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