PRAHS

2017-42788

- | US-MA-Boston
1 week ago
Title
Publishing and Submission Support Specialist - Boston

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 13,000+ 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 Publishing and Submission Support Specialist, 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?

 

As a Publishing and Submission Support Specialist, you will assume primary responsibility for the compilation and publishing of Wave 1-3 global regulatory submission types and submission support activities in accordance with Global Regulatory Affairs objectives.   The PSS will contribute to publishing strategies to ensure that compliant submissions are delivered according to the worldwide regulatory submission plan and regional/country requirements. Promoting a global e-working environment and driving efficient, standardized best practices for regulatory submission document management, the PSS will participate in project teams and/or partner with document authors to communicate submission processes, internal and external submission requirements and document standards.  Partnering with the Global Submission Manager, the PSS will provide input to the submission strategy to introduce efficiencies by promoting re-use of documents, adopting global dossier principles and standardizing processes to enable simultaneous compilation and publication of submissions. The PSS will also provide administrative support for submissions, e.g. obtaining certificates and key submission documents (Certificate of Pharmaceutical Product (CPP), Certificate of Good Manufacturing Practice (GMP), Letter of Authorisation), managing legalization, notarization and apostil and also ensure document submission readiness and final archiving of submissions.

 

  • Responsible for the publishing of Wave 1, 2 and 3 worldwide regulatory submissions (all submission types including eCTD, NeeS, Global Dossier, paper etc.). Supports report level publishing as applicable
  • Feeds into the publishing strategy to ensure maximum re-use of documents, introduces efficiencies and learnings from other projects and accounts for planned registration activities
  • Interfaces with authoring disciplines to ensure the creation of global submission ready documents and effective management of those documents in the EDMS
  • Participates in the final review of published submissions to ensure compliance to regulatory agency standards and requirements for electronic submissions
  • As a global publishing expert, through the GSM or direct interaction, ensures document authors have sufficient awareness and understanding of eCTD principles and lifecycle management and regional submission requirements to enable valid submissions
  • Provides input to the GSM on planning and publishing time required for a specific submission
  • May act as a publishing resource coordinator where more than one publisher is working on the submission (local or remotely) and as appropriate with publishing vendors
  • Provides recommendation for formatting standards and granularity of submission documents and contributes to the creation and management of templates and associated training materials e.g. quick reference guides etc.
  • Collaborates with other submission publishers to assure standard practices and quality submission outcomes Submission Support Activities:
  • Ensures final submissions are appropriately archived
  • Contributes to the central storage of all Regulatory submission documents, Telephone contact sheets with Authorities, submission correspondence and any other documentation pertinent to Regulatory Affairs record retention policy in the EDMS
  • Assures all documents are archived in a timely manner (within 2 weeks of receipt) and that offsite archives are appropriately inventoried for retrieval
  • Ensures that all submission meta data for the regulatory documents are captured in the applicable systems
  • By reviewing submission cover letters and content, identify and archive missing Regulatory Affairs documentation
  • Performs quality control (QC) on electronic documents and hard copies to ensure accuracy of the Regulatory Affairs archive
  • Supports the Regulatory Affairs department by retrieving difficult-to-find Regulatory Affairs documentation
  • Supports the uploading, exporting and if necessary QC of documents to/from the EDMS for internal Regulatory team and external partner documents
  • Supports the management of Regulatory Correspondence including archiving and maintaining health authority correspondence log
  • Acts on requests for administrative documents
  • Certificate of Pharmaceutical Product (CPP), Certificate of Good Manufacturing Practice (GMP), Letter of Authorisation.
  • Managing legalization, notarization and apostil as required

 

Qualifications

What do you need to have?

 

Education:  Bachelor’s degree is required.

Skills: 

  • 3+ years working within Regulatory Operations environment in submissions publishing
  • 3+ years document management experience
  • 3+ years experience of working within Regulatory and/or Regulatory Operations
  • 3+ years pharmaceutical industry experience Moderate experience working within Regulatory Operations environment in submissions publishing
  • Comprehensive document management experience
  • Broad experience of working within Regulatory and/or Regulatory Operations in a pharmaceutical industry experience
  • Fluent in the applied use of eCTD publishing tools and document management systems
  • Fluent with the drug development process and evidence of working with EU and/or US Regulatory Agencies supporting Regulatory Dossier review and approval processes
  • Excellent communication and interpersonal skills and the ability to manage priorities and work under tight timelines are mandatory
  • Excellent organization skills and sound attention to detail
  • Solid understanding of records management and document management systems and concepts
  • Experience of multitasking in a deadlined controlled and highly regulated environment
  • Understanding of systems and electronic technologies used to support records

 

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

 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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!