Scientific Officer Clinical Trials at The Ema Eu

We have a unique opportunity for you to demonstrate your scientific administration expertise within the leading EU institution of medicines and pharmacology based in Amsterdam

You would be a Scientific Officer in the Clinical Trials department, providing scientific coordination and regulatory and/or procedural support in relation to several areas of Clinical Trials. This is an exciting opportunity to join an institution that providesa truly international working environment where everyone is passionate about public health.

**Your responsibilities will help contributing to**:

- Development, evaluation and surveillance of medicinal products for human or veterinary use and of Maximum Residue Limits for substances for veterinary use;
- Referrals and related procedures for medicinal products for human or veterinary use;
- Management of requests for scientific advice, protocol assistance, parallel scientific advice with other decision makers (e.g. FDA or HTA bodies), as well as qualifications;
- Daily internal communication and interaction related to the management of the procedures with other colleagues across the Agency and the extended product team members;
- Prepare and contribute to the preparation of communication documents for allocated procedures;
- Contribute to the preparation of Scientific Committee meetings, Working Parties, Working Groups, Advisory/Expert Groups, including providing scientific support as applicable.
- **Profile**:
**Profile**:
University studies of at least 3 years in the Life Science field (e.g. biology, chemistry, biochemistry, pharmacy).

**Experience**
- Proven experience in Clinical Trials. Knowledge of the Clinical trial regulation and of CTIS is desirable.
- Experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting should have been obtained in:

- In the scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human or veterinary medicines
- In working with medicinal products containing medical devices and associated regulatory framework;
**Skills & Knowledge**
Knowledge of the EU pharmaceutical legislation and regulatory framework;
In information analysis and reporting on scientific/regulatory matters;
Clinical experience in a therapeutic field;
In working for a multinational organisation and managing multiple international stakeholders;
Nonclinical experience in a Good Laboratory Practice (GLP) laboratory.
Experience in dealing with external and internal stakeholders;
Excellent organisational, communication and time management skills
Fluency in English and at least one other EU language -Spanish, Czech, Danish, German, Estonian, English, French, Italian, Latvian, Lithuanian, Hungarian, Maltese, Dutch, Polish, Portuguese, Slovenian, Slovakian, Finnish, Swedish, Greek, Romanian, Bulgarian,Croatian, Norwegian, Icelandic

To apply, please send your CV in English and in Word format to Marie-Anne.
languagematters is acting as an employment agency in relation to this vacancy.