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2017-43540

2017-43540

Title 
Labeling Associate, Regulatory Affairs Global Labeling - Deerfield, IL or Boston, MA
Job Locations 
-
US-IL-Chicago
US-MA-Boston
Posted Date 
11/12/2017

More information about this job

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 13,500+ 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 Labeling Associate, Regulatory Affairs Global Labeling, 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 Labeling Associate, Regulatory Affairs Global Labeling, you will work within Regulatory Labeling and is responsible for the labeling master content documents (including USPI, patient labeling, packaging artwork, etc). Labeling Operations works in accordance with all current regulatory requirements, for all aspects of labeling document management (creation, revision, proofreading, format to FDA requirements (i.e. SPL), obtaining approvals, implementation, tracking and maintenance).  The Labeling Associate provides support for these responsibilities under varying degrees of oversight by a Labeling Product Manager and/or direction of a department Manager. Associate level to be determined upon candidate’s experience and qualifications.

 

  • Provides operational support for labeling development, management and review for assigned products/projects under oversight of Labeling Product Manager/Manager.
  • Provides regulatory support for labeling management and review, in accordance with applicable regulations and guidelines (e.g., ensuring that labeling meets the FDA Selected Requirements of Prescribing Information checklist), under oversight of Labeling Product Manager/Manager.
  • Organizes and compiles labeling annual report summaries under oversight of Labeling Product Manager/Manager.
  • Supports the conversion of labeling documents to required submission formats, i.e. Structured Product Labeling (SPL) using internal procedures or coordinating with outside vendor, within specified timelines.
  • Supports the conversion of Drug Listing or Establishment Registration, using internal procedures for coordinating with outside vendor, and file within specified timelines
  • Performs proofreading of labeling documents that is accurate, error-free and within time requirements.
  • QC/verifies of all labeling documents, such as content documents, package artwork and other labeling documents (as required).
  • Gathers supporting information and updates product labeling Activity and Implementation Log.
  • Coordinates the process of gathering appropriate labeling approvals through change control, project initiation processes, or equivalent.
  • Assists with the creation or revision of artwork for labeling, by communicating with Graphics Responsible groups under oversight by Labeling Product Manager/Manager.
  • Organizes, compiles and maintains all labeling documentation and assures compliance of manual and electronic label history files.
  • Supports Labeling Product Manager/Manager on submission and implementation strategy to ensure that all applicable agreed timelines are met.
  • Manages and tracks labeling information via databases, SharePoint sites, and other IT tools and systems, as required.
  • Responsible to learn, understand and apply current regulations and labeling guidelines as they relate to drug product labeling and US Labeling Operations.
  • Other duties as assigned.

Qualifications

What do you need to have?

 

Education:  Bachelor’s degree (BS/BSc or BA), preferably in a scientific or health-related discipline

Skills:  

  • Associate level to be decided based on the candidate’s experience and qualifications:

Labeling Associate 2:

  • At least 2 years of pharmaceutical experience in labeling or a related aspect of drug development. Basic knowledge of FDA and current regulations/guidances, particularly those related to labeling. Basic understanding of industry practice and the drug development process

Labeling Associate 1:

  • 0 - 2 years of pharmaceutical experience in labeling or a related aspect of drug development, preferred but not required. Interest to learn and understand about the FDA and current regulations/guidances, particularly those related to labeling. Basic understanding of industry practice and the drug development process are a plus.
  • Attention to detail and demonstrated ability to meet timelines.
  • Problem-solving skills and ability to generate proposed alternative solutions for elevation of issues to Manager.
  • Ability to communicate effectively in cross-functional setting. Works well with others.
  • Desire to learn, grow and contribute to US Labeling Operations group




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

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