Reporting to the Head of Paediatric Medicines, or the head of one of the sections in the Sector for Safety and Efficacy of Medicines (namely Anti-infectives and Vaccines, Central Nervous System and Ophthalmology, Endocrinology, Metabolism and Cardiovascular, Oncology, Haematology and Diagnostics or Rheumatology, Respiratory, Gastroenterology and Immunology), the jobholder will be responsible for a wide range of scientific and administrative tasks including:
- acting as a paediatric coordinator, validating and writing scientific reports on the assessment of applications for paediatric investigation plans and waivers in collaboration with the members of the Agency's Paediatric Committee and supporting joint paediatric-investigation-plan / scientific-advice procedures;
- acting as a product team leader or member, preparing Committee for Medicinal Products for Human Use (CHMP) scientific assessment reports and European public assessment reports, and scientific reports for relevant Committees for the procedure (Committee for Advanced Therapies or Pharmacovigilance Risk Assessment Committee), managing centralised applications through presubmission, submission, validation, evaluation and adoption of opinions, to liaising with rapporteurs and coordinating activities essential to the provision of objective scientific opinions of the CHMP;
- providing scientific support to the activities of the committees, working parties and drafting groups of the Agency and coordinating regulatory and administrative activities;
- liaising with colleagues across the Units within the Agency on product-related issues;
- attending internal and external expert meetings relevant for the therapeutic area;
- working on specific projects in the field of medicine development and regulation.
|Job role||Contract staff (long term)|
|Job type||Contract Agent|
|EMEA Business unit||Human Medicines Development and Evaluation|
The Agency only accepts electronic application forms submitted via e-mail. The application form is located under key documents. The application form can be completed using any official European Union language.
- Completed applications should be submitted to email@example.com. Note that applications e-mailed to any other e-mail address cannot be considered.
- You will need the latest version of Adobe Reader for the application form to work correctly. Download the latest version for free from Adobe Reader download.
- Once you have completed the application form click on the 'submit by e-mail' button at the top right of the application form. Your application form is transformed into an XML file and will be attached to an e-mail to be sent to firstname.lastname@example.org.
- Click on the send button of the e-mail to ensure that your application form is sent to the Agency.
- You do not need to write a message in the e-mail.
- You will receive an automated response from the Agency acknowledging receipt of your e-mail.
- Due to the large numbers of applications we receive, the system may encounter problems processing the large amounts of data close to the submission deadline. Applicants are therefore advised to send in their application form well ahead of the deadline.
- Curricula vitae (CVs) are not considered as an application. In order to be considered for the selection procedure, you must follow the application process as outlined above and submit the relevant, completed application form.
|Name||Language||First published||Last updated|
|General conditions - recruitment for the European Medicines Agency as Contract Staff (short-term or long-term)||(English only)||05/08/2011||01/02/2013|
Head of Human Resources
In case of technical difficulties please contact Maria Iglesias Martinez (tel: +44 (0)20 7523 6993) or Birgit Breen (tel: +44 (0)20 7523 7297), Monday to Friday 9.00am - 5.30pm