PRAHS

  • Global Submission Manager - Boston

    Job Locations - | US-MA-Boston | US-CT | US-NY-New York
    Posted Date 1 week ago(5/15/2018 11:21 AM)
    ID
    2018-46801
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it?

     

    Because we’re hoping you’re here for the latter.

     

    Who are we?

    We Are PRA.

     

    We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

     

    Who are you?

    You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Global Submission Manager, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

     

    Still here? Good. Because if this is you, we’d really like to meet you.

    Responsibilities

    What will you be doing?

     

    The Global Submission Manager (GSM) works effectively with global/regional cross functional teams to plan, monitor and deliver compliant regulatory submissions. The GSM introduces flexibility within and across therapeutic areas (development and marketed products) to provide broad regulatory submission support to ensure all submission and business deliverables are met in a timely manner. In collaboration with key members from global and local regulatory affairs, the GSM will compile and execute submission strategy plans for new marketing authorizations as well as submission strategies for the maintenance of existing drug licenses.

     

    • Management of the cross-functional global submission teams in the delivery of compliant submission components according to agreed requirements, timelines and processes. This includes planning and co/hosting and presenting at ‘kick-off’ meetings and preparing appropriate materials to facilitate team discussion, timeline mapping and submission strategy
    • Creation of standard project management tools such as submission risk, issue, escalation and communication plans (as appropriate) for larger/more complex submission types.
    • Identify appropriate submission KPIs in order to track project progress and present to cross functional submission teams.
    • Proficient in creating submission work breakdown structures and scheduling plans via the use of network diagrams and GANTT charts. This includes identifying and tracking critical path activities.
    • Firm understanding of submission deliverable dependencies and ability to reflect this in MS-Project in order to create and maintain detailed submission schedules as MS-Project tasks.
    • Conduct regular lessons learnt sessions to encourage process improvement and efficiencies within and across submission project teams.
    • Creation and maintenance of a submission forecast for functional/resource planning, in alignment with the Global Regulatory Plan.
    • Champion embedded processes and best practices within the global and local cross functional team in the creation of global submission ready documents and agrees and manages realistic dates for document handover in collaboration with the publishing group.
    • Facilitate the development of a global submission document plan (TOC) which specifies source submission content and tracks document creation through to approval and publishing. This includes familiarity with core dossier concepts and global document reusability.
    • Proactively escalates any timeline concerns, risks and issues that may impact the project and engages appropriate representatives to manage/mitigate outcomes.
    • Recognition of the internal and external interdependencies among submission activities that could have an impact to the schedule or quality of a submission and manage to ensure that submission goals are achieved on time and to the highest quality.
    • As a global submissions expert, ensures the project team has sufficient awareness and knowledge of e-submission principles and lifecycle management and understands, represents and communicates regional differences as appropriate within the context of global submission preparation.
    • Awareness of industry submission trends and ensuring changing policies and best practices are continually reflected in submission planning, monitoring and control.

    Qualifications

    What do you need to have?

     

    Education:  BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.

    Skills: Bachelor’s degree (or significant proven experience in a pharmaceutical environment)

    • Experience working within Global Regulatory Affairs, Regulatory Operations or Project Management environment.
    • Pharmaceutical/Healthcare industry experience
    • 5-8 years proven experience in Global Regulatory Affairs/ Project Management or Regulatory Operations
    • Proven experience in developing and implementing novel technological solutions and processes.
    • Fluent with the drug development process and evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes
    • Solid understanding of document management systems and concepts
    • Considerable experience of multitasking in a deadline controlled and highly regulated environment
    • Firm knowledge of regulatory procedures and a wider understanding of patient safety and commercial registration status.
    • Strong working experience of CTA’s, INDs, orphan drug applications (ODA), CTD dossiers for MAAs, national submissions, MRP/DCP and centralized procedures. Including post marketing submissions such as variations, renewals, labeling etc.
    • International travel may be required in accordance with project team requirements
    • Ability to attend offsite meetings that may involve overnight stay
    • Master’s Degree preferred
    • Qualified project management experience preferred
    • Experience of introducing new systems and procedures based on interpretation and application of regulatory agency guidance documents and mandated legislation preferred

    To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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