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Document Specialist (Temporary) - United States  

Company managed [?] Still accepting applications

Posted on : 13 May 2017

Project Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

Under limited supervision, assists with the maintenance and filing of records (documents, binders, electronic media, etc.) from Development Sciences 

  • Verifies document receipt
  • Reviews files at a high level for identification and consistency, (i.e.; number of pages and transmittal form accuracy)
  • Files, sorts, separates, photocopies, prints, scans, indexes, distributes labels and files a variety of clinical study records and documents.
  • May enter new and updated records information accurately in a variety of records management databases, such as the Vault eTMF, Clinical Document Management Database, Access and LiveLink (via scan / index software).
  • Performs searches and produces routine reports (e.g.  Study Site Listing from database, BI reports from Livelink, etc.).
  • Prepares inventory, shipment and retrievals of records to/from offsite storage.
  • Works with third party offsite storage facilities, in accordance with the DevSci Records Management (DSRM) SOP.
  • Acquires a basic understanding of Records Management database programs (i.e.; Access databases or other) and assists in the support of these database programs.
  • Fulfills requests for retrieval, reproduction, and re-filing of records or their electronic images (e.g. pdf) and other related records management requests.                                                                                                             
  • Communicates resource needs to manager to ensure DevSci Records Management is appropriately staffed and equipped for customer support as filing needs fluctuate.
  • Works according to and assists others in following DSRM department priorities.
    • 1-2 years applicable experience, including a minimum of 1-year relevant Records Management experience, with some knowledge of ICH/GCP, preferred.
    • Competent in the skills for the Records Management Assistant and the following:
      • Experience working with regulated files or in a records management environment is preferred
      • Strong organizational skills
      • Ability to identify and respond to problems
      • Strong time management skills
      • Able to identify Records Management related issues and take appropriate action
      • Basic understanding of records management requirements in Drug Development
      • Strong communication skills
      • Ability to work well with others (strong interpersonal skills)
    • Has an understanding of the clinical study phases involved in Drug Development and the corresponding records requirements.

  • AA preferred.
  • Combination of education and work experience providing competencies to perform the required responsibilities specific to position.

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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.