Senior Scientific Specialist - Inspections
- European Medicines Agency
- Amsterdam (Stad), Noord-Holland (NL)
- EUR 8400.00 - 9600.00 Monthly
- Closing date
- Jun 11, 2023
- Life Sciences, Biochemistry, Biology, Pharmacology, Physical Sciences, Chemistry
- Job Type
- Senior Scientist
- Organization Type
About this position:
The European Medicines Agency (EMA) promotes and protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA serves a population of approximately 400 million citizens living in the EU. EMA operates at the heart of the European medicines regulatory network - a unique collaborative model between over fifty national regulatory authorities for both human and veterinary medicines in the European Economic Area, EMA and the European Commission.
The Human Medicines Division oversees and manages human medicines throughout their lifecycle, from evidence generation planning, through evaluation and monitoring of medicines to interfacing with stakeholders to facilitate access and optimal use. The division also supports the European regulatory network to produce patient-centred high-quality scientific opinions.
We are looking for senior scientific specialists leading the Agency strategy to facilitate the regulation of advanced and innovative manufacturing of medicinal products and active substances. The role will involve leading relevant activities within the EU Medicines Regulatory Network, through interactions with experts from the 27 EU Member States, working groups/ Committees as well as with International Partners , the Commission and WHO .
The role will be located within the Agency’s Inspection Office and will also involve scientific and administrative support to Inspection Office tasks including inter alia, contributing to GMP guideline development, co-ordinating inspections, co-ordinating assessments of quality defects, support to the Agency GMDP Inspectors Working Group.
The successful applicant will be expected to progress the Agency and Network strategy in the following areas;
- Advanced and innovative manufacturing of active substances and medicinal products, including new Quality Control and Quality Assurance approaches arising from the use of inter alia, sensors, data analytics and artificial intelligence.
- Innovations in manufacturing facilities and manufacturing networks including decentralised manufacturing, modular systems and portable systems.
- Convergence with international partner authorities on the regulation, including GMP standards, for advanced and innovative applications and facilities.
- Enabling and facilitating post approval change management as per the ICH Q12 principles
Here is the link to the Role Description of Senior Scientific Specialist outlining 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:
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.
1. possess a university degree (minimum of four years) in Life Science (e.g. pharmacy, biology, chemistry, biochemistry) or Medicine (human/veterinary) or Engineering that must have been obtained by the closing date of this vacancy notice, and at least 9 years’ professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.
2. possess a university degree of three years in Life Science (e.g. pharmacy, biology, chemistry, biochemistry) or Medicine (human/veterinary) or Engineering that must have been obtained by the closing date of this vacancy notice, and at least 10 years’ professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.
For general condition 1 and for specific conditions 1 and 2 you will be required to provide proof in the application form and 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:
Out of the years of professional experience required above (eligibility - specific conditions), at least 5 years of GMP experience (specifically in the areas of GMP inspections, manufacturing of medicinal products for human or veterinary use, quality control, quality assurance and/or innovative manufacturing) 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 the scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human or veterinary medicines (including medicinal products containing medical devices and associated regulatory framework).
Skills & Knowledge
- Critical review and drafting of scientific and regulatory documents for expert and lay audiences;
- Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU, including ICH guidelines relevant to the role, and their application;
- Presenting scientific, or regulatory matters at a high level (eg to experts);
- Proficient in MS Office suite.
Competencies you will need to have:
- Regulatory frameworks & strategy Advanced
- Applied Knowledge Management Advanced
- Scientific product lifecycle and procedure management Intermediate
- Adaptability and agility Intermediate
- Coping with Pressures and Setbacks Advanced
- Analysing and problem solving Advanced
- Ethics and Integrity Intermediate
- Team collaboration Advanced
- Customer centricity Advanced
- Results orientation Advanced
- Communication Advanced
- Cross-cultural sensitivity Advanced
- 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 Competency Framework for more information on the definitions of these competencies and their associated levels.
Nice to have:
- PhD and/or specialization in a relevant field of study (Medicine or Life science disciplines);
- Master’s degree in regulatory science, regulatory affairs, quality, manufacturing or pharmaceutical technology.
Background and/or work experience in the following areas:
- Novel/innovative manufacturing technologies or products (e.g. ATMPs, bedside manufacturing, continuous manufacturing);
- GMP for veterinary medicinal products or active substances;
- Inspection or manufacturing of substances of human origin/medicinal products revived from substance of human origin.
Skills and Knowledge
- Knowledge of the typical issues in quality, non-clinical, or clinical development in one or more therapeutic areas;
- Knowledge of general methodology for quality, non-clinical, or clinical development;
- Knowledge of trends and innovative developments in the area of pharmaceutical manufacturing and bordering legislation (e.g. medical devices);
- Knowledge of analytical methods and research skills.
Selection procedure timelines
Please note that timelines may change.
Deadline for applications
29 May 2023 23:59 CET
Week of 19 June 2023
Week of 17 July 2023
End of July 2023
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: Need to Have requirements and grade specific competences and sub-family competences are essential to progress your application further. Before the start of the selection procedure, it is decided which assessment criteria and competences will be used at each stage of the process. Certain criteria / competences will be assessed / scored only for shortlisted candidates during interviews (and/or tests). Please consult the Careers at EMA - Guidance on selection and recruitment (epigraph 1.3. selection procedure) for an overview of the criteria and competences assessed at each stage of the process.
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 the assessment criteria listed above (Need to have criteria and sub-family competences).
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.
Only the candidates with the highest total marks at the shortlisting stage will go through to the next stage. The Selection Committee may decide to limit the number of candidates invited to the next stages. Please consult the Careers at EMA - Guidance on selection and recruitment (table on epigraph 1.3.6 Preliminary and final assessments) for an overview of the thresholds.
Next steps of selection may include a preliminary assessment (Webex/Teams, remote test, etc.). Most assessments will be conducted remotely. All assessments are based on the assessment criteria listed in this vacancy notice.
Candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) as part of the selection process. 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. Please consult the Careers at EMA - Guidance on selection and recruitment (epigraph 1.3.3 selection procedure) for an overview of the criteria and competences assessed at each stage of the process and the type of assessment tolls used.
Reserve list and/or job offers
This selection procedure is run to create a reserve list. Each candidate having reached the final step of the selection procedure will be notified via e-mail whether she/he has been placed on the reserve list. Candidates should note that the placement on a reserve list does not guarantee an employment offer.
Reserve lists are usually valid until the end of the next calendar year. The validity of the Reserve Lists may be extended.
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 careers website.
Conditions of employment
In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates.
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