Senior Business Systems Analyst- Quality, Regulatory, And Clinical

Epizyme Cambridge , MA 02138

Posted 4 weeks ago

Epizyme, Inc. is a fully integrated commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK (tazemetostat), for the treatment of patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in an ongoing confirmatory trial. The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.

Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies. Join a dynamic, diverse and fun work environment consistent with Epizyme's cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.

We are seeing motivated candidates to join our IT Enterprise Business Systems Team as Senior Business System Analyst. The role of Business Systems Analyst is an important function within the Epizyme's Information Technology Department, with the responsibility to ensure the technical and business solution needs are met for our Quality, Clinical and Regulatory departments.

Key Responsibilities:

  • Execute process redesign and solution implementation of IT GxP projects

  • Provide system support for Veeva Vault QualityDocs, RIM, eTMF and PromoMats; in addition to related third-party applications

  • Provide system support for LMS ComplianceWire and Docebo

  • Facilitate requirements gathering, solutions design, and documentation

  • Prepare project plans and status reports, while providing track progress on the projects

  • Provide cross-functional support with day to day issues

  • Manage request intake and drive prioritization with business partners

  • Ensure compliance to change control and SDLC procedures

  • Coordinate and manage application support with vendors and external consultants

  • Facilitate cross functional/interdepartmental Implementations

  • Help design and implement best practices for IT

Required Experience/Skills:

  • 2-3+ years working in a Life Sciences company/organization, supporting GxP systems with direct validation experience

  • Experience working with and supporting Veeva Vault solutions QualityDocs, RIM, Clinical eTMF and PromoMats

  • Experience working with and supporting Sparta Systems Trackwise Digital

  • Experience supporting Learning Management Systems

  • General knowledge of portfolio/project management methodologies

  • Ability to multi-task and manage multiple projects simultaneously

  • Ability to work as an individual contributor and as a member of a team

  • BA/BS in Computer Science, Information Technology or related field, is a plus

Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.


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Senior Business Systems Analyst- Quality, Regulatory, And Clinical

Epizyme