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Regulatory Affairs Associate - Document Management System Support - 12 month STC Cambridge United Kingdom,  

Mundipharma Research (company)


Posted on : 23 August 2017

Project Description

Job Introduction

 Support and maintain the Regulatory Affairs Document Management System 

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

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.

General:

  • 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.

Key Competencies

.

Main requirements

  • 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.

Contact Information

Name: Sophie Anthony
Email: MR.HR@mundipharma-rd.eu
Telephone: 01223 400400
Adress: Mundipharma Research Limited
Unit 196
Cambridge Science Park
Milton Road
CB4 0GW

Locations

Cambridge (UK)

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