Scientific officer – European Medicines Agency (EMA)

The European Medicines Agency is looking to build a reserve list for possible upcoming recruitment as a Senior Scientific Administrator to work on GXP inspections related activities with the focus to support the development of guidelines and procedures.

Furthermore, the Senior Scientific Administrator will also support the international collaboration and implementation of relevant pieces of legislation.

The Agency is a decentralised body of the European Union located in London. Its core responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines. The Agency is a multicultural organisation with staff from EU and EEA member states.

EMA works closely with the national competent authorities for human and veterinary medicines of the 28 European Member States, the three European Economic Area countries (Norway, Iceland and Liechtenstein) and the European Commission (collectively, the European Medicines Regulatory Network).

Candidates on the valid reserve list may also be considered for a different post within the same grade if the job specification and the nature of the role are similar.

This announcement is governed by the General terms and conditions for selection procedures for Temporary Agents.

Specific objectives of the jobholder:

Reporting to the Head Service of Clinical and Non-Clinical Compliance or Manufacturing and Quality Compliance, the jobholder will be responsible for the following tasks:

• Coordination of GXP (GMP, GCP, GLP and PhV) inspections as relevant
• Assistance in the development, administration and maintenance of databases (including EudraGMDP and EUdraCT)
• Provide leadership in international collaboration on GXP inspection activities
• Provide scientific, technical and administrative support for projects involving the Agency’s committees and groups of experts related to activities of the inspections department (see EMA website: Home / Human Regulatory / Inspections or Home / Veterinary Regulatory / Inspections)
• Scientific, technical and administrative support for development of guidelines and procedures
• Provide Secretariat support, as necessary, for meetings of scientific expert groups including inspectors’ working groups
• Providing responses to external queries on inspection and related matters
• Manage a portfolio of products including coordination of suspected quality defects
• Secretariat support, as necessary, for meetings of scientific expert groups including inspectors’ working group
• Support the development of training programme, in conjunction with the GXP Inspectors Working Groups, for use to support these groups’ activities and contributions to international training programmes and capacity building
• Represent the Agency in external fora
• Support to the implementation of relevant pieces of legislation, e.g. Clinical Trial Regulation

Elements that will be taken into account in determining candidates to be invited for test/interview:

• Good, practical, knowledge of European pharmaceutical legislation, guidelines and procedures relevant to the activities described
• Extensive experience GXP activities and supervision of inspection or audit programmes or of clinical research
• Extensive experience in clinical trials, pharmacovigilance, manufacture, quality assurance, pharmaceutical engineering or regulatory affairs in the pharmaceutical sector either within a regulatory authority or industry environment
• International experience relevant to the activities described
• Experience in project management
• Experience in the use of information and communication technologies
• Ability to communicate and present the Agency’s position externally and to staff internally
• Ability to network and interact effectively with colleagues and work as part of a team and take the lead as needed
• Experience in working in a multicultural environment
• Experience and knowledge in the following areas will form part of the oral assessment:
• Strong understanding of the European and global GXP environment
• Strong sense of responsibility
• Strong communication skills, and in particular, the ability to explain complex issues
• Negotiation skills and ability to influence a wide range of stakeholders
• Ability to establish personal credibility and respectful relationships with managers, staff and other stakeholders and an ability to promote open communication
• A can-do and proactive approach, brining urgency to his/her work environment
• Team-player and confiden
• Ability to work under pressure
• Tact, discretion and diplomacy
• Experience in multicultural organisations
• Excellent written and oral communication skills in the English language

Location: London, United Kingdom

Application deadline: 14 August 2015

Read more and apply here.