Regulatory System Expert
- Type Contract
- Salary competitive
- Location Leiden, South Holland
- Sectors Regulatory Affairs
Regulatory System Expert
This position is responsible for supporting the tools used for electronic publishing of regulatory submissions by RSMO Publishing and Local Operating Companies, working independently with minimal supervision.
The incumbent will support the training of junior specialists and oversee the work of others from an operational perspective to ensure quality of output. The incumbent will be proficient in eCTD lifecycle standards and requirements.
The incumbent may also be assigned various independent or team-based projects primarily focused on process improvement initiatives or the testing and implementation of new submission related technologies.
The incumbent is expected to identify opportunities to streamline processes or enhance overall quality of output.
PRINCIPAL RESPONSIBILITIES: % OF TIME
* Support current electronic document management and publishing tools to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions. 40%
* Troubleshoot and provide first-line support to RSMO Publishing. Serve as a helpdesk for inquiries regarding regulatory requirements and guidelines. 40%
* Monitor electronic publishing requirements and determine the scope for tool maintenance/development. 5%
* Assess processes to ensure that organizational responsibilities are met for quality, delivery, and effectiveness. 5%
* Develop opportunities for business process improvement. 5%
* Assist in technical training of team members & provide ongoing guidance to ensure internal standards/procedures are adhered to. 5%
DECISION-MAKING AND PROBLEM-SOLVING:
The incumbent follows established procedures and standards with a high degree of independence. The incumbent exercises a high level of autonomy and judgment on assignments and priority within the context of the submission process. The incumbent will receive multiple assignments, but is expected to manage workload within established parameters of priority and timelines. Overall priorities are normally designated by supervision.
The incumbent will have high level of independence and autonomy. Work assignments and prioritization of activities will be established by line supervision consistent with business requirements and workload, but the incumbent will have a high degree of latitude to manage workload within established limitation and decision-making authority.
* Meet regularly with members of the organization to identify and resolve issues and to assess quality, delivery, and effectiveness.
* Interact and support the publishing managers for LSM submission needs and issues.
* Exceptional interpersonal and teamwork skills are required and must possess strong communication skills.
* Exercise good judgment and communicates effectively with all levels of the organization.
* Participate in the creation and review of local and global procedures relating to electronic compilation and transfer of regulatory submissions.
KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:
* Academic training in computer science or equivalent; Bachelors or beyond in relevant discipline
* Must have enough experience in pharmaceutical industry submission publishing or related technical skills to be able to operate independently in this role
* Proficiency in submission related FDA or EU regulations & guidelines e.g., eCTD
* Expert working knowledge of Publishing related tools, like InSight Publisher, ISI Publisher, InSight for Validation, Extedo Global Validator, Lorenz eValidator, InSight for Viewing, ISI Toolbox etc.
* Strong communication skills: oral, written and effective listening
* Sound understanding of information management concepts and tools needed to support business area.
* Practical understanding of evolving technologies in support of business area.
* Use various technical skills and experience to solve publishing/document processing issues
* Can demonstrate a solid command of the technical tools needed to perform job duties.
Are you the Technical Expert I am looking for? Please contact me: n.vanalfen[at]realstaffing.com or give me a call: 020 522 1588