Lupin Pharmaceuticals (Company Headquarters)

  • Clinical Development Associate - Contract Position

    Job Locations US-FL-Coral Springs
    Posted Date 1 month ago(12/17/2018 2:24 PM)
    Job ID
    2018-2459
    # of Openings
    1
    Category
    Administrative/Clerical
  • Overview

    Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

     

    We are looking for a Contract Clinical Development Associate.  This contract would be for at least a 6 month period. 

    Responsibilities

    The Contract Clinical Development Associate will be responsible for providing assistance to the clinical leadership for development and progression of clinical studies and submissions, the clinical study associate is responsible for supporting assigned respiratory drug development projects of global clinical research programs across all phases of research. The clinical study associate serves as key clinical support for clinical development in the respiratory pipeline.

    Essential Duties and Responsibilities
    • Provides support to Associate Director, Clinical Development
    • Responsible for organizing, communicating and evaluating team objectives for clinical studies
    • Responsible for formatting requirements of clinical documentation and/or provision to medical writing
    • Assist with development of clinical protocol training slides
    • Maintains strong working knowledge of protocols for assigned projects
    • Responsible for organizing and filing required documentation electronically
    • Assist with documentation of project related meetings
    • Timeline creation and management
    • Management of clinical monitor per company SOPs and regulatory requirements
    • Assist with documents for IND/NDA/CTA and other regulatory documents (e.g. briefing documents, protocols, IBs)
    • Contribute to preparation and/or review of any documents related to clinical study drug development requiring a clinical or regulatory background
    • Assist in preparing medical or scientific information/documentation/analysis when appropriate for protocol preparation or regulatory submissions
    • Assist with filing and maintaining regulatory and study documents
    • Track study progress using study tracking tools, ensuring timely and quality updates
    • Assist in development and revise annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissions
    • Perform administrative tasks to support team members with clinical and regulatory execution and ensure International Conference on Harmonization, and Good Clinical Practice procedures are followed in all study aspects
    • Promote and develop use of electronic tools in the medical review/validation
    • Assist in coordination and preparation of technical content/document packages for regulatory submissions, ensuring compliance with required regulations and interpretations

    Qualifications

    • B.S. or B.A. in Life Sciences
    • Previous experience in Clinical Research, Regulatory Affairs and/or Drug Development required (at least 3+ years within pharma industry or CRO)
    • Clinical drug development and regulatory processes and understanding of the design and conduct of clinical trials
    • Scientific expertise or interest and ability to learn in the domain of assigned study/project
    • Experience with asthma and/or COPD clinical trials is highly-preferred
    • High level of autonomy and motivation; self-starter
    • Quality focused and well organized
    • Strong communication skills (verbal and written)
    • Demonstrates flexibility and adaptability
    • Ability to work on multiple projects with aggressive timelines
    • Ability to synthesize the information, good presentation skills
    • Ability to work autonomously and to efficiently and effectively provide status reports
    • Ability to anticipate and timely escalate issues and to define appropriate action plans
    • Team and results oriented
    • Working knowledge of all relevant regulatory guidelines and standards (e.g. GCP, ICH, and FDA/EMA Guidance documents), as well as practices and expectations of Quality within GCP

    Options

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