Pharma Labeling Regulatory Affairs Analyst / Remote Work

Pioneer Data

  • Pearl River, NY
  • 4 days ago
  • Remote

    Highlights

    Our client, a world-leading Pharmaceutical Company in Pearl River, NY is currently looking for an Pharma Labeling Regulatory Affairs Analyst to join their expanding team. Experience in interpreting and applying global and local regulatory guidance around labeling/regulatory and associated supportive documentation desirable.

    Numbers & Facts

    LocationPearl River, NY (
    Remote
    )

    Description

    Position Details:
    Our client, a world-leading Pharmaceutical Company in Pearl River, NY is currently looking for an Pharma Labeling Regulatory Affairs Analyst to join their expanding team.
    Job Title: Pharma Labeling Regulatory Affairs Analyst / Remote Work
    Duration: 10 months contract, extendable up to 48 months
    Location: Remote Worker
    Note:
    The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
    You may participate in the company group medical insurance plan
    Job Description:
    Pan-Portfolio Strategy & Support Business Analyst
    Education:
    Bachelor's Degree or equivalent
    Advanced academic qualification/degree desired, equivalent relevant professional experience will be considered.
    Experience and Attributes:
    8+ years' experience in global/multi-national pharmaceutical environment, including direct experience either in Labeling or Regulatory Affairs role.
    Experience with Business Analytics required.
    Experience with interacting autonomously with leaders and working in a matrix team environment a must.
    Experience in interpreting and applying global and local regulatory guidance around labeling/regulatory and associated supportive documentation desirable.
    Experience in labeling and/or artwork processes preferred
    Demonstrated track record of delivery to time and quality
    Technical Skills
    Proven fluency with use of soft skills and negotiation skills
    Ability to transform ambiguous situations/discussions into structured outcomes
    Ability to partner with wide range of business stakeholders, crossing multiple divisions across multiple countries/cultures
    Proven leadership driving highly complex projects to meet evolving business needs
    Ability to manipulate and understand complex data.
    Ability to synthesize and communicate complex information and analyses to a variety of audiences in both verbal and written format
    Clear and adaptive verbal and written communication skills
    Excellent problem-solving capabilities
    Strong facilitation and project management skills
    Ability to evaluate and diagnose process and systems
    Knowledge and experience with labeling or similar tracking systems
    Knowledge of XML, regulatory tracking, document management systems, various reporting tools
    The preferred candidate will have experience with Pfizer's labeling intelligence systems (PfLEET, GDMS, PEARL).
    This position is responsible for coordinating and supporting to maintenance of the Pfizer's labeling intelligence interfacing with internal stakeholders to support Pfizer's labeling portfolio in alignment with business needs and compliance standards.

    Specific responsibilities:
    Coordinate the labeling universe maintenance process, including analysis and tracking of updates. Ensure regular data quality checks are performed support the resolution of identified issues.
    Coordinate the implementation of label tracking strategies throughout the lifecycle of Pfizer's products including end of label maintenance activities are performed.

    Specifications:
    This role has expertise in clinical, global and international labeling and/or artwork functions and interdependencies.
    The preferred candidate will have experience with Pfizer's labeling intelligence systems (PfLEET, GDMS, PEARL).

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