• LFB USA - Senior Project Manager

    Job Locations US-MA-Southborough
    Job ID
    2018-1322
    # of Openings
    1
    Category
    Program/Project Management
    Type
    Full Time
    Company
    LFB USA
  • Overview

    Develop and implement Regulatory planning strategy for timely delivery of regulatory output across LFB USA and in conjunction with concurrent activities with the LFB SA (parent company in France). Organize the implementation of RA strategies for investigational products awaiting Regulatory Submission and/or FDA meeting actions and for post approval products and any products bought into the LFB portfolio.

     

    This position is both a leadership and role-modeling project time-management and cross-program oversight position and will require extensive hands-on involvement, people skills and communication sensitivity, and contemporary cross-cultural global work experience. This position will interface with all disciplines within drug development that include (but are not limited to) CMC, Clinical, Med Writing, PV, Toxicology, Pharmacokinetics, and EU/French Project Management and Development and include individuals who may represent external partners, vendors, consultants, contractors, and stakeholders. This position requires the candidate to demonstrate foresight and analytic skills, be independent, be action oriented, be an excellent communicator with the ability to work well within international project teams to ensure all regulatory strategic events, interactions, and corporate submission timelines are met.

     

    Responsibilities

    • Develop and manage timelines for activities that result in completion of submission of BLA, INDs and amendments for domestically generated investigational products and international (French) LFB products when needed.
    • Strategize, coordinate competing priorities for preparation and submission of international Clinical Trial Applications, Variations, and Orphan Designation (or similar) for consideration by Regulators.
    • Identify/anticipate solutions to critical path elements, bottle neck issues, overlapping commitments and urgencies.
    • Ensure that cross functional resources are assigned and held accountable for task completion.
    • Provide regulatory affairs project management and tactical guidance for teams handling regulatory and clinical work including pre-market, post-market environments.
    • Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed.
    • Ensure team deliverables are in compliant with the quality system process and standard product development process.
    • Effectively communicate project plans, status and resource requirements to both core teams and senior management.
    • Responsible for achieving timely and successful implementation of governmental regulations while ensuring best-in-class practices.
    • Oversees the delivery of electronic data submitted to health authorities through up-to-date, accurately registered gateways or portals.
    • Work within project teams to guide and advise regarding most efficient Regulatory approaches to development and approval pathways.
    • In conjunction with Directors, communicate with government agencies (national and, when appropriate, international) as needed at a peer-to-peer level to resolve regulatory delays to expedite product approvals.
    • 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, ensuring project results meet requirements for technical quality, reliability, schedule, and cost.
    • Facilitate monthly program review and updates to corporate trackers and reporting platforms
    • Coordinate contributions of third-party contractors/vendors/stakeholders/suppliers/experts etc., to ensure timely preparation and submission of electronic dossiers to health authorities.
    • Establishes meaningful metrics and KPIs.

    Qualifications

    • Advanced biotech, science, or human health service degree required along with significant industry experience preparing unique documents for regulators as well as INDs and BLAs/NDAs/Combo applications and having been directly involved in handling the tasks surrounding engagement with U.S. (emphasis) and international health authorities.
    • 8 to 10 years of experience in the pharmaceutical industry and a working understanding of the U.S. and ROW regulatory environment.
    • Must have project managed/program oversight of at least two BLAs/NDAs that were accepted for filing.
    • Team and goal oriented mindset to interact with the various functional groups.
    • Significant experience is required in organizing CMC, nonclinical and clinical sections of INDs and BLAs.
    • Good computer skills and willingness to roll-up-the-sleeves is essential.
    • Strong project management skills/experience required.
    • Prior experience and facility with Microsoft Project, Gantt, or similar project management platforms required.
    • Intuitive, people-oriented communication skills and work style in managing work completion in a cross-cultural collaborative environment.

               

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