About the job

ProductLife Group are looking for a skilled and enthusiastic student living in Denmark, who can work approximately fifteen (15) hours per week from the client’s offices in Valby. The activities to be provided by students will be varied. Full training will be given. The activities may include the tasks outlined below:

Group 10
Responsabilities

  • Administrative activities
  • Import/export of documents to and from Pluto
  • Support to EDMS activities and library services –data clean-up, training logs, load of documents, re-indexing, load of articles
    • Provide review of packaging texts.
  • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hub
    Others
  • Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
  • Assist in the management of ProductLife Quality Management System.
  • To participate in training as required for ProductLife staff.
  • Support the Pharmacovigilance group in the production of Regulatory Authority and Ethics Committee documentation.
  • To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.

Profile

ProductLife Group applies the principles of equality and diversity in the workplace and opposes all forms of unlawful discrimination.

Education and Experience

  • Currently studying for a bachelor or master’s degree related with Library & Information science
  • Is structured and detail-oriented, Excellent organizational and interpersonal skills
  • Used to use and work with IT tools
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel would be a plus
  • Eager to learn and deliver high quality work
  • Understands and speaks fluent English and Danish for daily contacts
  • Is in the beginning of their studies or has a study period of minimum 2 years left

 

Student Regulatory Affairs Assistant 436