PRAHS

  • Senior Regulatory Labeling Specialist - Remote

    Job Locations (All) | US-Remote | Canada-Remote
    Posted Date 1 week ago(11/7/2018 1:21 PM)
    ID
    2018-50220
  • Overview

    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 labeling. 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 Senior Regulatory Labeling Specialist has responsibility for activities associated with the creation, management, and implementation of US labeling, in conjunction with the Global Labeling Lead and Regulatory Lead.

    Responsibilities

    What You Will Be Doing: 

    • Functions as a Subject Matter Expert (SME) for US regulatory labeling requirements. Identifies and provides regulatory labeling guidance to ensure that labeling development processes conform to all applicable regulatory, legal and company requirements.
    • Based on knowledge of regional regulatory requirements for the US, provides labeling expertise to the Global Labeling Lead (GLL) and Regulatory Lead (RL) for labeling development, management and review. Controls the consistency of labeling content across a product family.
    • May facilitate regional labeling working groups for US packaging artwork. May participate in label working groups for prescribing information.
    • Manages all labeling development activities for new product introductions and for updates of current product labeling, with minimal supervision, while working with external vendors to execute the final deliverable.
    • Ensures the US labeling content meets current CCDS.
    • Initiates the creation or revision of artwork for labeling, by communicating with Graphics Responsible groups.
    • Ensures that change control processes are followed to maintain accuracy of change during revisions/versioning of documents.
    • Manages pending labeling implementation timing, including new submissions, pending submissions, planned submissions and changes in approved timelines through formalized systems and processes.
    • Supports GLL and/or RL for submission and implementation strategy, to ensure that all applicable agreed timelines are met.
    • Establishes and manages cross-functional relationships to ensure control and continuous improvement of labeling programs to meet business needs and regulatory requirements
    • Ensures that tracking of development and implementation activities are documented and maintained.
    • Initiates and/or implements procedures, processes, or programs that result in improvements, corrective actions, problem prevention, or cost-savings
    • Supports US Labeling Operations Manager, as needed
    • Evaluate risks and appropriately escalate issues to management.
    • Participate in training Labeling Associates on relevant labeling policies and procedures, as needed

     

    Qualifications

    What You Need: 

    • Bachelor’s degree (BS/BSc or BA), preferably in a scientific or health-related discipline or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated
    • Pharma/CRO experience
    • At least 5 years of pharmaceutical experience, with at least 2 years in labeling or a related aspect of pharmaceutical drug development.
    • Significant knowledge of FDA current regulation/guidance, particularly those related to labeling and demonstrated ability to apply regulations, guidelines and regulatory processes to provide regulatory guidance
    • Strong understanding of industry practice, scientific principles and regulatory/quality systems in the drug development process.
    • Demonstrated project management skills, attention to detail and ability to meet timelines.
    • Demonstrated problem-solving skills with ability to generate proposed alternative solutions for to Manager.
    • Ability to communicate effectively in team and cross-functional setting.
    • Excellent oral and written communication skills.
    • Demonstrated negotiation and interpersonal skills.
    • Ability to work in a team environment but can function equally well independently
    • May require approximately up to 10% travel.
    • 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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