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Quality and Regulatory Systems Analyst

Location: Cambridge
Posted on: January 12, 2022

Job Description:

Quality and Regulatory Systems Analyst at Relay Therapeutics The -Quality and Regulatory -Systems -Analyst -will -be a member of the Development Informatics group -playing -a critical -role in supporting the growth of our Pharmaceutical -Development -organization -with responsibility of continually developing and executing on the -Quality and -Regulatory -technology roadmap. You will -partner -with the growing -Quality Assurance and Regulatory Affairs -groups to understand their business needs and -how technology can address those needs. You will provide -support -of -systems used to support quality and regulatory, connect system data and process flows, -and manage -the delivery of future systems. - Your Role:

  • Act as -technical -lead for major technology -projects -
  • Hands on IT partner for -the -Quality and -Regulatory -groups -from helping with -day-to-day experiences to implementation projects -
  • Continually refine -and execute -the -Quality and Regulatory -technology roadmap -
  • Represent the needs of -Quality and Regulatory -within the -IT -organization for -enterprise efforts, including collaboration and security -
  • Manage technology -efforts from implementations to ongoing enhancements, including managing partners -who provide -support, implementation, and validation services
  • Work with external partners, including -publishers, -content providers, and service providers on data access, automation, and governance -
  • Work independently and collaboratively with your business and IT colleagues to ensure the right technology is planned for and managed to enable future strategic capabilities - Your Background:
    • 6+ years' work experience with -managing systems supporting -clinical operations, -clinical data management, -or clinical informatics -
    • Demonstrated experience in design, deployment, and support of systems -supporting -regulatory and quality -
    • Experience supporting -EDMS system(s) (Veeva preferred) -
    • Working knowledge of -eCTD and IDMP -
    • Practical knowledge of GxP -quality guidelines and regulations -for -Quality, Regulatory, -and IT, including FDA, MHRA, EMA, and ICH -
    • Demonstrated hands-on experience with -data focused technologies -including -collection, -standardization, and visualization -
    • Outstanding collaboration and communication skills -
    • Ability to build consensus across functions to align priorities and resources - About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts -fearless -and -relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us! - Company policy requires that all employees be fully vaccinated against COVID-19, and all new hires must be fully vaccinated (as defined by the CDC) by the time they start employment. By applying to this position, you are confirming that, if hired, you can satisfy this express condition of employment. The Company will make reasonable accommodations under applicable law for qualified individuals to enable them to perform the essential functions of the job, unless doing so would create an undue hardship for the Company. 29 Newbury Street
      3rd Floor
      Boston, MA 02116
      P (617) 585-2000

Keywords: THIRD ROCK VENTURES, LLC, Cambridge , Quality and Regulatory Systems Analyst, Professions , Cambridge, Massachusetts

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