Regulatory Data and Information Specialist in Research Triangle Park, North Carolina | DiversityInc Careers
 
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Regulatory Data and Information Specialist

.pre {white-space: pre-wrap;} Your tasks and responsibilities

 

The primary responsibilities of this role, Regulatory Data and Information Specialist, are to:

 

  • Ensure that all submissions to Environmental Protection Agency (EPA) and selected State Agencies  (CA,FL, and NY) are submitted using the most recent electronic standard by maintaining current knowledge of regulatory body expectations. All Data Submissions to the US authorities should be managed electronically with the Global IT system DDCT (DART Dossier Compilation Tool) regardless of the published output requirements (electronic or paper) to ensure a proper history of submitted content (e.g. for litigation, data compensation, divestment purposes). Develop a detailed understanding about the involved systems (like DART, DDCT, Nexus) and external submission requirements and needs of the involved authorities. As all agencies are transitioning to electronic submissions, their requirements and processes are changing. The RDIS provides transition solutions until the required changes can be implemented into the Global systems. The RDIS assists the Managers of NA and Global Documentation on the compilation of complex submissions (e.g. new Active Ingredient Joint submissions);
  • Analyze and optimize processes and data management systems within the North American (NA) Regulatory Science organization. (Documentation/Archiving, Federal Registration, Compliance, States Registration and Label) and interface functions (e.g. Supply Chain, Marketing, Business Development) to increase regulatory compliance, efficiencies and flexibility. Responsible for implementing process and data management changes into the organization; in particular, ensure optimization of the Structured Label Database. Small IT solutions to support changes and streamlining of information will be developed. Prepare and file new O&I project proposals for approval decision by the US leadership team including project NPV calculations. Upon Approval, manage the O&I project as the Business Project Lead;
  • Maintain a thorough understanding of regulatory relevant electronic systems and data sources, e.g.:
    • Global BCS systems: DART/DDCT, RegPrime, Nexus, GRIP, eLabelServer, SAP Master Data, SAP Business Warehouse;
    • US BCS Systems: Kelly, Structured Label Database (BRIDG & BRIDG(ES), Bryant Christie MRL Database, TradeFlow Database;
    • US Authority Systems: NPIRS, ALSTAR, EPA PPIS and PPLS, EPA Docket system;
    • Future systems: Regulatory Intelligence, Data Compensation.
  • Deliver rapid responses to various departments by linking and analyzing data systems that support different business needs such as Legal litigation Support, Divestment and Registration Transfer Support, Data Compensation Claims Support and Regulatory Decision building;
  • Represent US Regulatory to external (e.g. AGRIAN, CDMS, EPA on the Web Distributed Label and SMART label initiative) and internal Stakeholders (e.g. Marketing (digital farming)) with respect to Regulatory Data Management including electronic exchange of or access to regulatory data in a reliable and compliant manner;
  • Support regulatory Global IT projects and address North America business needs and regulatory requirements. (e.g. DART/DDCT, RegPrime, GRIP, Nexus, Label4SafeUse);
  • Work in the documentation team to build and/or maintain the framework for archiving and submission tasks, methods and guidelines;
  • Represent all IT related activities for the US Regulatory Group (e.g. PWP@work, Record Custodian, SharePoint Administration) to help to implement changes and solving issues.

     

.pre {white-space: pre-wrap;} Who you are

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • Bachelor’s degree with a minimum of 2 years’ experience in a life science or other science oriented industry or related field;
  • Must possess a good working knowledge of data management and IT infrastructure preferable in Archiving and Documentation Practices;
  • Must have experience in or be able to quickly acquire the following IT skills:
    • Designing and Querying advanced relational databases;
    • Basic Document Management System knowledge;
    • Basic SharePoint Configuration and administrative knowledge;
    • Advanced MS Office experience including macro programming;
  • Good written and oral communication skills, including negotiations skills for external and internal customers;
  • Strong commitment to accuracy and attention to detail;
  • Must be flexible and adept at accommodating shifting priorities;
  • Must be able to evaluate and compile information in a concise and useful fashion;
  • Must be able to responsibly handle extremely confidential company information;
  • Must be able to drive change management within the organization.
.pre {white-space: pre-wrap;} Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.