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And Medical Devices Shortages Specialist

Medicines and Medical Devices Shortages Specialist Type of position: Temporary agent Job Type: Extended until 12 September 2024 at 23:59 CET Job grade: AD06 Internal job grade and Interagency: AD06 and above Type of position: Temporary agent Selection procedure reference: EMA/AD/10618 Job title: Medicines and Medical Devices Shortages Specialist Talent Pool: AD06 Science & Regulation Deadline for applications: Extended until 12 September 2024 at 23:59 CET Salary: 6,418.36 Euro (including local weighting) plus benefits (see calculators on the right) (based on a fulltime contract (40hrs/week)) XXAbout this position:We are looking for a Medicines and Medical Devices Shortages Specialist to provide scientific secretarial support to the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), management and support of the Single point of Contact Working Party (SPOC WP ) and Industry Single point of Contact (i-SPOC) systems for medicines, and case management of shortages of CAPs and critical shortages. Job holder's role and responsibilities: Management of assigned shortage cases, ensuring timely and relevant communication between all stakeholders, with a view to mitigate and manage shortages and ensure availability of product for patients; Discussion of cases escalated to the Medicine Shortages SPOC WP; Identification of shortages/events that could lead to a major event for discussion at the MSSG. Here is the link to the Role Description of Medicines and Medical Devices Shortages Specialist outlining the generic duties and responsibilities: Apply if you meet these eligibility criteria:To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:General conditions:1. enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;2. have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);3. have fulfilled any obligations imposed by applicable laws concerning military service. Specific conditions:1. possess a university degree (minimum of three years) in scientific (pharmacy, chemistry, biology or an equivalent) or technical (e.g. applied science) disciplinesand at least 3 years of professional experience after obtaining the relevant degree, that must have been obtained by the closing date. General Condition 1 and Specific Conditions will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure. Only candidates eligible will be assessed by the Selection Committee in accordance with the Assessment Criteria below.You will also need to have:Experience: At least 3 years of experience in the management of shortages, supply chain and manufacturing of medicinal products for human use and/or medical devices, obtained through previous work in academia, industry, notified body, EU competent authority. This experience can overlap or be in addition to the 3 years of professional experience required for Eligibility and listed under Specific Conditions 1. Experience in interaction with stakeholders such as patients, healthcare professionals, academia, pharmaceutical and/or medical device industry. Competencies you will need to have:Role competencies Shortage management & availability - Intermediate Sub-family competencies Regulatory frameworks & strategy - Intermediate Applied knowledge - Intermediate Grade competencies Adaptability and agility - Intermediate Analysing and problem solving - Intermediate Prioritising and organising - Intermediate Core competencies Ethics and Integrity - Intermediate Team collaboration - Intermediate Customer centricity - Intermediate Results orientation - Intermediate Communication Intermediate Cross-cultural sensitivity - Intermediate Continuous learning and self-development - Intermediate The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its for more information on the definitions of these competencies and their associated levels.These are considered Nice to have:Experience In working in a multicultural environment; Project management experience in leading, coordination, planning, implementation, evaluation and timely delivery of projects. Skills & Knowledge A clear understanding of the role of EMA within the legislative framework for the regulation of medicinal products and medical devices. Selection procedure timelines Deadline for applications extended until 12 September 2024 at 23:59 CET Preliminary Assessments Foreseen: 08 October 2024 Final assessments Foreseen: between 21 and 25 October 2024 Decision expected First week of November 2024 Selection process Only eligible candidates (see eligibility criteria) will be assessed by the selection committee. Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competences in different steps of the selection procedure. Note: Candidates who fail any assessment linked to any Need to Have requirement, Sub-family competencies, Grade specific competencies, Role competencies and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria. X Shortlisting In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria, Sub-family competencies and Role competencies. The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form. To carry out this assessment, each of your responses will be awarded points (0 to 10). The points are added up to identify those candidates whose profiles best match the duties to be performed as advertised in the vacancy notice. X Assessments Next steps of selection may include a preliminary assessment. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice. Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies (pass score is 26 out of 100 points and above). Additional assessments, such as cognitive (e.g. deductive reasoning) assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed. X Reserve list and/or job offers When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview. More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our . X Conditions of employment In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates. The successful candidate will be required to relocate to the Netherlands to pick up duties.

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