• Regulatory Publishing Specialist - Boston or Home Based

    Job Locations (All) | US-MA-Boston | US-Remote
    Posted Date 4 days ago(11/9/2018 3:17 PM)
  • 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 lifesaving drugs into the hands those who need them most.


    Who are you?

    You are a leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You have a serious passion for clinical development. You never settle for what is but are always pushing clinical development forward to what it could be. You motivate others to do the same. 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.

    The Principal Regulatory Publishing Specialist will assist with submissions and operational activities.



    What You Will Be Doing: 

    • Responsible for both Submission and Document Level Publishing.
    • Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including MAAs/NDAs, INDs, CTAs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
    • May interface with project managers, regulatory product managers, and or content authors to discuss routine and non-routine submission preparation.
    • Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
    • Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
    • Liaise with functional source areas to ensure documents are compliant and submission ready. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
    • Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
    • Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.


    What You Need: 

    • Bachelor’s degree in relevant field of study or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language
    • 5+ Years of eCTD publishing experience (global eCTD filing experience preferred).
    • Experience with CTA submissions desired.
    • Knowledge of health authority procedures/guidance's regarding electronic submissions required.


    Minimum Qualifications

    • Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic.
    • Knowledge of industry trends regarding electronic submissions.
    • Proficiency with MS-Office Suite and Adobe Acrobat applications.
    • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
    • Excellent organization, written/verbal communication, and attention to detail
    • Knowledge of health authority procedures/guidance's regarding electronic submissions.
    • Knowledge of Electronic Document Management Systems.
    • Ability to balance multiple tasks to meet priorities and timelines.
    • Strong attention to detail.


    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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