Manages curricula and learner roles, including periodic review of curricula, learner roles, and training requirements with department heads and QMS Admin.
Coordinates with study team leads to update study-specific training documents, routes for approvals, and manages study team learner role membership in the LMS.
Coordinates with document owners and Doc Control to create or revise Training Requirements with new or revised controlled documents and training materials.
Serves as a dedicated strategic partner to assigned operational or functional business areas.
Translates business needs and regulatory expectations into effective, practical, and inspection-ready learning solutions.
Accountable for shaping learning approaches that support business outcomes, regulatory compliance, and inspection readiness.
Vertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. They employ scientists, business professionals, and researchers united around a common goal–to discover, develop, and deliver innovative medicines.
Lead GxP system qualification and validation activities for the eQMS, COTS, and TPS using a risk-based approach.
Administer and continuously improve eQMS quality event workflows - CAPA, nonconformance records (NCR), deviations, change controls, and document management.
Lead and maintain the Vendor Qualification Program and Third-Party System (TPS) audit schedule, including initial qualification, periodic requalification, performance monitoring.
Cogstate is advancing the science of brain health - making it faster, easier, and more accurate to assess cognition across clinical trials, healthcare settings, and everyday life. Our global team of experts spans psychology, data science, operations, and technology.
Develop independent assessments and evaluation metrics and updates/creates TBKs
Ensure content aligns with organizational standards, regulatory requirements, and best practices.
Collaborate with subject matter experts and authors to resolve content issues and improve quality.
Terrestris leverages technology to create better mission outcomes through better human performance. They form strong client and team relationships through transparency and strive to create an environment where their team can let their excellence shine through.
Design and manage end-to-end certification programs.
Own the planning and coordination of learning programs.
Drive cross-functional alignment across learning stakeholders.
PointClickCare is a healthcare technology company that provides cloud-based software solutions for the senior care industry. They help long-term care providers manage patient care, billing, and regulatory compliance. Their team operates in a highly collaborative, cross‑functional environment.
Build role‑based skills for staff, partners, and customers—ensuring content quality, relevance, and alignment to product and organizational goals.
Drive program adoption and performance by coordinating training delivery, enabling readiness across audiences, monitoring certification progress, and optimizing learning pathways based on data and feedback.
Ensure operational excellence and scalability by maintaining certification standards, managing exam and credentialing processes, and collaborating cross‑functionally to keep learning experiences current, consistent, and impactful.
PointClickCare is a healthcare technology company. They provide cloud-based software for the senior care industry, enabling better care and outcomes for residents. The company operates in a fast-paced and innovative environment.
Provides system administration for LMS and LMS system training as required.
Provides technical support for LMS users, diagnosing and resolving system, access, enrollment, and content issues in a timely manner.
Ensures managing and tracking of DHA training courseware in production and testing and conforms to DHA LMS mission and/or program guidelines.
NetImpact Strategies Inc. (NetImpact) has been a Trusted Advisor driving impact through digital transformation for the Federal Government for over a decade. As Trusted Advisors, NetImpact professionals partner with customer agencies to deliver solutions that empower them to not only meet their missions but also realize their strategic vision.
Prepare, compile, and submit regulatory documents to IRBs/ECs
Support migration from Complion to Florence eRegulatory
Maintain CVs, licenses, and GCP documentation
UniTriTeam is a global organization supporting clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Execute the strategic FMA training plan supporting the therapeutic area Business Unit and new product launch initiatives.
Develop and refine the GMA new hire FMA learning curriculum for their therapeutic area (i.e., Nephrology/Immunology).
Lead virtual classrooms, competency assessments & certifications (live and virtual) and serve as a key presenter and co-author of the Peak Performers series.
Otsuka is a global healthcare company committed to developing and commercializing innovative products in neuroscience, nephrology, and digital medicine. The company employs 34,400 people worldwide, including 2,200 in the U.S., and is dedicated to defying limitations for patients and earning recognition as a Great Place to Work.
Serve as the enterprise Inspection Readiness Leader by defining strategy, policies, standards, governance frameworks, roles, responsibilities, escalation pathways, and operating models across all ARI sites and functions.
Design, implement, and sustain a standardized enterprise inspection readiness program, including lifecycle models for pre-inspection, active inspection, and post-inspection phases.
Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.
American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer, developing, manufacturing, and supplying high-quality generic and branded injectables. They have locations in New York, Ohio, and California and sales territories nationwide and have been in business for over 50 years.