Senior Specialist GMS Training

PURPOSE AND SCOPE:

Support the GMS Training Office in the implementation, administration, maintenance and further development of the global GMS training system, the related regulatory training process and the IT-systems used for this purpose.
Work on projects for the continuous improvement and maintenance of learning management (LMS) systems and electronic tools (e.g. ComplianceWire).

Management of tasks in the area of GMS training, in particular supporting and guiding local training administrators in the implementation, administration, maintenance of the global GMS training system.

PRINCIPAL DUTIES AND RESPONSIBILITIES:  

Support the execution of subsequent activities within the department Management Systems Controls & Services (MaCoSe)/GMS Training Office within the Global Management System (GMS) and the related training process and systems:(Support) maintenance of the regulatory training process and MS implementation processes and associated tools.

• Support the establishment and maintenance of a global FME communication network for (local) experts on the GMS Training process (Training SMEs)
• Administration of the established regulatory Learning Management System (e.g. ComplianceWire) on global level.
• Support, guidance and training for local LMS administrators as required.
• Create and apply current and appropriate learning concepts for the respective target audiences to support training and implementation.
• Provide a regulatory training offer to standardize and support the implementation of necessary processes and regulatory requirements. In particular, this includes:
• Coordinating the qualification of regulatory key functions, such as Local Management System Representatives in consultation with the respective Corporate Management System Representative.
• Organizing a regular offer of (virtual) classroom training courses (e.g.,GMS Training Weeks, coordination of webinars by external service providers))
• Provision of a “Quality & Regulatory” training catalog within the currently established platforms
• (e.g., Learning Management System, Intranet)
• Administration of the GMS training offer (e.g., training catalog, document templates, organization of training registrations, verification documentation, interface to internal and external service providers and   to the German works council, coordination of trainers)
• Design and implementation of training courses, including the creation of suitable teaching materials
• Creation of interactive teaching materials (e-learning) using suitable authoring tools (e.g. Articulate 360), as required. 
• Support the creation and maintenance of curricula and training matrices for own department
• Guide owners of curricula and training matrices in their creation and maintenance
• Administrative tasks in the current Learning Management System (e.g., creation and maintenance of curricula and training matrices, user groups, training courses)
• Guide GMS process owners and trainers in creating a training strategy and respective training matrices as well as review of submitted training strategies and process training matrices as part of change control of GMS documents.
• As part of the document change control process, perform training task related approvals.
• Support preparation and check of Local Implementation Requests (LIR) and associated Quality and Regulatory Implementation Support (QRIS), specifically with regards to training-relevant aspects.
• (Support with) project work and system implementations in accordance with specific task assignments
• Preparation of analyses, (status) reports and presentations on the GMS processes for training and implementation (e.g., as input for the management review).
• Administration of electronic platforms used by the department for information sharing and document storage (e.g., MS-Teams,  MS- SharePoint, Intranet).

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and work environment characteristics described here represent those employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

EDUCATION:

Completed scientific, medical or technical education at a technical college or university

EXPERIENCE AND REQUIRED SKILLS:        

• In total at least 3 to 6 years working experience
• At least 3 years of professional experience in the field of medical devices / medical technology or pharmaceuticals
• Preferably work experience in a multinational company Good communication skills
• Good analytical skills
• Good conflict management skills, proactive and solution-oriented approach, openness to new tasks
• Basic Understanding of applicable normative and legal requirements for the medical device/pharmaceutical industry
• Basic Understanding of the applicable normative requirements that are the basis for FME certifications and management systems  (e.g., ISO 13485, ISO 9001, ISO 14001, GxP, MDSAP)
• Basic Understanding of about electronic learning management systems (LMS) and/or integrated software solutions for management systems.
• Good knowledge in the use of MS-Office applications including SharePoint
• Experiences with electronic Learning Management Systems would be an advantage Good knowledge of written and spoken English
• Good knowledge of written and spoken English
• Further foreign language skills are an advantage

ACKNOWLEDGEMENT:

I acknowledge that I have read and accepted this job description.  I understand what is expected of me in this position, and I am able to perform the essential functions as outlined with or without reasonable accommodation.  Furthermore, I understand that the duties and responsibilities listed in this job description are intended only as illustrations of the various types of work that may be performed.  The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.  If I have any questions about duties and responsibilities not specified in this job description that I am asked to perform, I should discuss them with my immediate supervisor or my Human Resources representative.