Training System Specialist
- Provides global training service and operational systems support together for all supported business for all relevant Clinical & Pharmacovigilance regulatory compliance training.
- To ensure appropriate rollout of GxP training plans in the global learning management systems, training communications and training operations.
- To contributes to the reporting and analyse training compliance metrics within the department and the supported business functions, and follow-up where required
- Contributes to the execution of the training operations plan and strategy
- The majority of the role will focus on supporting the team with daily activities relating to training administration and managing our existing Learning Management System
- Supports the test, upload, deployment of training programs required as part of the Quality Management System
- Acts as the Learning System Specialist responsible for the end to end process and works closely with the Standard Operating Procedures (SOP) and Learning Solutions group to ensure timely planning and execution of the training roll-out plan for procedural documents.
- Oversees the administration of global training programs within the Learning Management Systems, maintains and updates role based training curricula, and delivery of training compliance reports in accordance with defined processes as well as the Medical Compliance Training Grid (MCTG).
- Leads Learning System projects by incorporating concepts of Project Management Methodology (PMM)
- Collaborates with key business stakeholders by ensuring MCTG and functional training grids are accurate and current
- Performs quality checks on all training assignments, training deployments, metrics reporting and communication provided on behalf of Training Systems & Operations Group
- Communicates the training requirements to business stakeholders including completion timelines, curricula requirements for existing employees and new hires, in addition to providing status updates on all inquiries through the use of all available communication channels.
- Proficient technical and business expertise for all IT tools required to support the administration of the Training Quality System in a compliant and efficient manner and integrated training evaluation methodologies that measures training effectiveness.
- Provides Tier 1 customer service support and ensures issues (e.g., user requests, change control) are resolved in a timely manner.
- Generates innovative ideas and/or investigate potential methods in streamline workflow processes
- Ensures that business partner expectations for training operations and deployment are met.
- Contributes to the Learning Solutions Team to set strategies and achieve the long-term goals & objectives
Qualifications and Experience:
- Bachelor degree in Science-related subject or other related field or equivalent work experience.
- 3-5 years in the pharmaceutical industry, preferably development and working in a GxP regulated area; broad understanding of global expectations of Health Authorities in the area of Pharma Development.
- Experience in preparation and administration of GxP training programs.
- Training and Curricula development experience including oversight and administration of validated electronic training management systems
- Considerable organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams.
- Demonstrated knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills.
- Substantial knowledge of all services and activities provided by PDQ, Change Management expertise.
- Fluency in written and spoken English.
- Relevant working/residency permit or Swiss/EU-Citizenship required