Chaucer

  • SOP Writer

    Job Locations US-New Haven, CT
  • Overview

    Chaucer is a 30-year-old management consultancy built on pragmatism, collaboration, and taking a hands-on approach to solving our clients’ problems and adding value to their businesses. By drawing on an individual's strengths, creativity and passion, the consulting team is able to produce results that last.

    Since our MBO in 2014 we have grown a lot as a business, but are able to maintain the same 'family feel' of our earlier days. Our client list boasts some of the world’s most recognizable name brands but we have more opportunities for people to develop and more space for them to carve that path out in a way that suits their development needs.

    Currently we are looking for strong management consultants, people with a background in supporting the delivery of large & complex transformations and change programs, specifically within Global Clinical Operations and R&D.

    At your level you must be able to stand on your own with clients, but still working within teams. Experience would include Project Management, SOP Writing, Business Analysis and/or Process Improvement and PMO (Chaucer's own PMO).

    Specifically, you will:

    • Create, update and improve procedures within global R&D including the following functions:
      • Clinical Operations, Data Management (Site Oversight, Monitoring, Compliance), Biostatistics, Quality, Risk Management, Document Retention
    • Work with cross functional teams & SMEs to collect requirements and validate language in procedural documents; acts as thought partner to these “customers”
    • Author SOPs, Working Practice Documents and supporting guidance and instructions
    • Understand required regulations and compliance requirements to incorporate into procedures.  Ensure processes include appropriate controls and verification points.
    • Follow procedural document authoring, versioning and approval process
    • Assist in maintaining prioritization of documents requiring updates or creation based on business urgency (e.g. inspection finding vs. continuous improvement)

     

    Background should include:

    • Ability to work with a sense of urgency and diligence in engaging SMEs and other required personnel to prioritize this effort
    • Knowledge of Clinical Operations/SOP best practices to apply here or suggestions for improvements
    • 5+ years of prior business experience, prior consulting experience at a professional services firm a plus
    • 5+ years’ experience in Life Sciences/pharmaceutical/regulatory environment in a clinical operations setting
    • Experience creating and supporting project management plans
    • Proven success in contributing to a team-oriented environment
    • Proven ability to work creatively and analytically in a problem-solving environment
    • Excellent communication (written and oral) and interpersonal skills required
    • Strong Excel and PowerPoint skills; Visio and other visualization and analytical tools a plus
    • Solid project management skills, PMP a plus
    • MS Project
    • Excel, PowerPoint & Word Ability to integrate into client environments seamlessly

     

    At Chaucer, we are looking for outstanding talent to help support the growth of our Life Sciences Practice. We seek professionals who have demonstrated high academic/professional achievement, leadership, communication skills, and have a strong interest in consulting, with specific expertise or knowledge in the following:

    • Clinical Operations
    • Systems Implementations & Integrations
    • GCP Quality
    • Medical Affairs
    • Product Launches
    • Procurement & Software Licensing
    • Regulatory Affairs
    • CTMS/CDMS
    • Sample Management
    • Records Information Management (eRIM; LIMS)

     

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