Regulatory Affairs Associate - Document Management System Support - 12 month STC - United Kingdom
Support and maintain the Regulatory Affairs Document Management System
As Soon As Possible
Document Management System:
- System administrator for the Document Management System
- Provide on-going User Support and Training for System Users.
- Assist in the management of user’s accounts, permissions and perform other system administration functions for Document Management System.
- Assist in development of new business processes and templates around the use of Document Management System
- Assist in Maintaining and updating the Document Management System Manuals and other training support materials.
- Propose potential Process Improvements for the Document Management System
- Assist in the Research of new technology and application to regulatory systems and identify potential system upgrades.
- Raise items or issues related to Regulatory Affairs Systems with the appropriate Regulatory Affairs team members. Perform actions to address these items or issues, as agreed.
- Be aware of and keep up to date with current legislation appropriate to European Regulatory Affairs.
- Work as a team player and perform all reasonable tasks related to regulatory activities in accordance with the priorities of the department.
- Plan and execute tasks according to the agreed schedule and priority.
- Ensure that the appropriate standards of good regulatory practice are employed.
- Ensure that department procedures are followed. Develop and document new working practices as appropriate.
- Can demonstrate the ability to work to company values and leadership attributes.
- Take responsibility for personal training and development in order to reach and maintain the required skills, knowledge and experience to perform the role.
- Has practical experience in the regulatory field or has other strong industry experience.
- Good practical understanding of the function and application of databases and document management systems.
- Ability to support system based training.
- Ability to influence other people.
- IT/Science based degree or equivalent, or HND or equivalent qualified with some applied industry experience.
- Positive work style, with an approachable, flexible manner.
- Strong analytical and problem-solving skills.
- Good written and oral communication.
- Has developed a good understanding of relevant Regulatory Guidelines.
- High attention to accuracy and detail.
- IT literate particularly in relation to using databases and document management systems
- Ability to work to strict deadlines and manage own time.
- Is results focussed.
- Actively works as a team member.
- Ability to work with minimum supervision.
- Ability to build effective working relations internally and externally.
|Adress:||Mundipharma Research Limited |
Cambridge Science Park