Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson.

Johnson & Johnson

NL - Regulatory Affairs Consultant - Dossier Development and Operations Technical Integrator

Posted Feb 23, 2021
Job ID: JJJP00005833
Location
Leiden
Duration
10 months
(Feb 28, 2021 - Dec 30, 2021)
Hours/week
40 hrs/week
Payrate range
Unknown

Johnson & Johnson is currently recruiting a RA Consultant - Dossier Development and Operations Technical Integrator for our Janssen Vaccines & Prevention site in Leiden.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science, bringing innovative ideas, products and services to advance the health and well-being of people.


As a RA Consultant - Dossier Development and Operations Technical Integrator you are responsible for writing Modules 2.3 and 3 of Vaccines IND/IMPD, MAA/BLA dossiers.


Responsibilities:

  • Ensures compliance with regulatory agency regulations and interpretations.
  • Prepares responses to regulatory agencies' questions and other correspondence.
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
  • Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  • Provides solutions to a variety of problems of moderate scope and complexity.
  • Organizes and maintains reporting schedules for new drug application and investigational new drug applications.



Requirements:

  • 3-5 years experience in writing these dossiers and  in Module 2.3 and Module 3 Dossier Development.
  • Good communicating skills (written and verbal).
  • Able to work in CMC (Chemistry, Manufacturing and Controls) Teams.
  • Great attention for detail.
  • Hands on experience in documentum based systems.
  • Degree in pharmaceutical sciences, biochemistry, biology, biomedical science or chemistry.



EXTRA INFORMATION:

  • Flexible working hours.
  • Currently you will work remotely because of COVID-19.
  • This is a contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Yacht. Yacht can offer you a payroll contract for the duration of the assignment at J&J or a freelance (ZZP'er) contract.

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