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    Managing Director - Saint Paul, MN, United States - Parexel International

    Parexel International
    Parexel International Saint Paul, MN, United States

    2 weeks ago

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    Description
    As one of our ex-FDA colleagues describes it: "you get to see a lot of cool stuff very quickly".

    If you're looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there's no better place to be than as a Vice President, Technical on Parexel's Regulatory Strategy team (RS) As a VP, Tech you'll work on a variety of assignments, diverse product types for clients with wide-ranging geographical considerations while enjoying fantastic career opportunities and work/life balance all while working from home.

    As a critical member of Parexel's Regulatory Strategy team, you'll be creating opportunity for clients throughout the product lifecycle.

    Sharing your scientific, technical, regulatory and/or commercial expertise with them, so that they can bring better, safer products to market, in line with regulators' requirements.

    You'll be working at a senior / strategic level, and leading teams of respected SMEs in supplying the answers.

    We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team

    A Technical Vice President must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations.

    Project Execution
    Works within a team environment or individually based on the project needs
    Works within broad project guidelines and leads issue and conflict resolutions
    Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives
    Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
    Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
    Produces quality work that meets the expectations of RS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RS are met
    Manages project engagements (small or large)
    Interacts with the assigned Project Assistant to ensure accurate financial management and for general project support
    Provides guidance to project team members and acts as a mentor to junior staff
    Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field
    Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RS are met
    Regularly quoted by general and industry news outlets
    Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise
    Consulting Activities and Relationship Management
    Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies
    Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction
    Acts as a loaned executive for a client when required
    Facilitates resolutions to possible problems or conflicts within the project team and/or the client
    Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities
    Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RS management and account management
    Education - MD or PhD required

    Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications.

    Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc.

    or a related Medical role ie. Extensive Oncology experience is required.
    The ability to travel up to 20-30% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance

    Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
    #LI-REMOTE #J-18808-Ljbffr


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