Regulatory Publishing Specialist II

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Updated: October 14, 2019
Location: Morrisville, NC, United States
Job ID: 5816

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Overview

You’re driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

 

Responsibilities

This opportunity is with Syneos Health Consulting, an industry-leading consulting firm specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. You’ll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop achievable strategies for our clients. High-level details in one sentence about the role. More specifically:

This mid level position is for a full time publishing specialist to work in Syneos Health's Regulatory Consulting and Submissions. Syneos Health serves as regulatory consultants to the pharmaceutical and medical devices industries. The Division provides regulatory support to clients of Syneos Health through preparing, assembling and submitting regulatory applications to various government agencies.

  • Perform Assembler tasks within the document publishing system. This includes but is not limited to creating publications, modifying outline, assigning and transforming documents and adding cross references.
  • Perform Publishing tasks within the electronic publishing system. This includes but is not limited to adding special sheets, applying rules, preparing for publishing, and publishing.
  • Perform QC tasks within the electronic publishing system and QC of the published output.
  • May create, key and assemble client deliverable documents and submissions using standard word processing or publishing systems and utilities (InSight Publisher, CoreDossier, ISIToolbox, Acrobat).
  • May review documents for legibility, completeness, and accuracy.
  • May log and track regulatory documents, publications and other relevant materials.
  • May organize and compile regulatory documentation, perform pagination, clean-up and duplication tasks.
    May QC materials prepared by team or client.
  • May receive and deliver client information/documents, with significant supervision.
  • May provide alternatives for completing assigned tasks.
  • Prepare and assemble applications (INDs, NDAs, ANDAs, DMFs, etc.) for submission to the FDA.

Job Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

  • Minimum of a bachelor’s degree, with preference given to a science degree
  • 2-5 years or equivalent experience in an office environment, with preference given to drug/device/biologic-related industry,
  • experience with electronic publishing of regulatory submissions.
  • Knowledge of medical/scientific terminology and/or FDA regulations and procedures desirable.
  • Computer skills including experience with relevant software such as InSight Publisher, Documentum, CoreDossier, Ezsubs, ISI Toolbox, MS Word for Windows, Access.
  • Able to work independently, understand and carry out detailed instruction.
  • Attentive to the detail and accuracy of information, and possess good communication, organizational and interpersonal skills.
  • Must be able to work concurrently on several projects, each with specific instructions that may differ from project to project.

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality of life balance.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Here, you’re a part of the big picture. We work hand in hand to guide pre-market development through post-market commercial strategy. Knowledge sharing across advisory groups unlocks the innovation and unique strategies our end-to-end commercialization projects require. Our collaborative mindset means every project is a chance to solve a new challenge, learn from your teammates, become better-rounded, and evolve your career.


WORK HERE MATTERS EVERYWHERE | How will you accelerate biopharmaceutical commercialization?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)


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