Share this job

Senior Scientific Specialist

Type of position:  Temporary agent
Job Type:  11 October 2022 at 23.59 CEST

Job grade: AD08 

Internal job grade and interagency:  AD08 and above

Type of position: Temporary agent 

Selection procedure reference: EMA/AD/9116 

Job title: Senior Scientific Specialist 

Deadline for applications: 11 October 2022 at 23.59 CEST 

Salary: 7.431,71 Euro (including local weighting) [1] plus benefits (see calculators on the right)

 

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 450 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.

XX

XX

About this position:

We are looking for Senior Scientific Specialists to provide scientific, regulatory or procedural input and oversight relating to the safety, efficacy and quality aspects of human medicines.

You will provide scientific coordination and regulatory and/or procedural support in relation to the any of the following areas (which of the following aspects will depend on the business needs/opportunity available at the time of recruitment):

  • Development, evaluation and surveillance of medicinal products for human use;
  • Product Lead for medicines authorised via the Centralised procedure;
  • Provide scientific, regulatory or procedural input and oversight relating to the safety and efficacy aspects of human medicines;
  • Contribution, management and scientific oversight over EMA nonclinical and clinical assessments and risk management procedures; 
  • Referrals and related procedures for medicinal products for human 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;
  • The delivery of high-quality product information through assessment of invented names, product information and its translations, mock-ups and specimens, and provision of advice and training on product information guideline principles;
  • Provide scientific input, advice, oversight and/or management relating to the detection, assessment, understanding and prevention of adverse drug reactions (ADRs) or any other human medicine;  
  • Use epidemiology on the basis of real-world data to study populations, diseases and the performance of medicines for the assessment of the safety and performance of medicines once the authorisation process has been started.
  • Preparing the summary reports and supporting the coordination of the initial assessment for orphan medicines designation, paediatric investigation plans.

Depending on the area for recruitment, as Senior Scientific Specialist, you will also drive the development and maintenance of EU or international guidelines, e.g. good pharmacovigilance practices (GVP), clinical and scientific guidelines, and standards for the system, as well as development and implementation of evidence-based process improvements.

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 four years) in Life Science (e.g. pharmacy, biology, chemistry, biochemistry) or Medicine (human/veterinary) that must have been obtained by the closing date of this vacancy notice, and at least 9 years’ relevant 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. 
or
2.   possess a university degree of three years in Life Science (e.g. pharmacy, biology, chemistry, biochemistry) or Medicine (human/veterinary) that must have been obtained by the closing date of this vacancy notice, and at least 10 years’ relevant 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:

Experience
Minimum 5 years experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry, or a healthcare / academic setting.  

This work experience should have been obtained in one or more of the following fields: 

  • scientific, clinical, regulatory, or procedural aspects of the research, development, authorisation, production, therapeutic use or supervision of human medicines; 
  • working with medicinal products containing medical devices and their associated regulatory framework.

Skills & Knowledge

  • Excellent organisational skills;
  • Excellent communication skills;
  • Proficiency in performing critical reviews and preparation of scientific and regulatory documents for both expert and lay audiences;
  • Proficiency in the English language;
  • Proficiency in the Microsoft Office suite;
  • 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;
  • Knowledge and understanding of current legislation and guidance in the area of expertise and ability to interpret those and advise on their application;
  • Presenting scientific, or regulatory matters at a high level (eg to experts).

Nice to have:

Education

  • PhD and/or Specialisation in a relevant field of study (Medicine or Life science disciplines)    
  • A Master’s degree in regulatory science and or Regulatory Affairs.

Experience

  •     Experience gained in European or global regulatory affairs in a regulatory agency or the pharmaceutical industry;
  •     Experience  gained in research and development of medicines for the purpose of regulatory submissions; 
  •     Experience in information analysis and reporting on scientific/ regulatory matters; 
  •     Experience in conducting multi-centre, multi-database studies, incl. study design, data collection, data analysis and interpretation of results.

Skills & Knowledge

  •     Good knowledge of clinical trials and/or pharmaco-epidemiological concepts applied in study design and analysis;
  •     Good knowledge of project management tools and methods, including for planning, resourcing, executing, evaluating and managing changes;
  •     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.   

Competencies:

Sub-family Competencies    

  • Regulatory frameworks & strategy    Advanced 
  • Scientific evidence management    Intermediate 
  • Scientific product lifecycle and procedure management    Intermediate 
  • Applied Knowledge Management    Advanced 

Grade Competencies    

  • Adaptability and agility    Intermediate
  • Coping with Pressures and Setbacks    Advanced
  • Analysing and problem solving    Advanced

Core Competencies    

  • 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

Selection procedure timelines

 

Deadline for applications

11 October 2022 23:59 CEST 

Preliminary Assessments

Approx. between 11 and 18 November 2022 

Final assessments

Approx between 05 and 14 December 2022

Decision expected

Approx. between 19 and 23 December 2022

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             XXXX                                         XXXXXX  XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX                                                                                                                                                                                                                                                             XXXXX                                                                                                                                                                       

X

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 (need to have and nice to have) in different steps of the selection procedure. Before the start of the selection procedure, the selection committee decides which assessment criteria will be used at each stage of the process. Certain criteria will be assessed / scored only for shortlisted candidates during interviews (and/or tests).

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 the assessment criteria listed above (Need to Have and Nice to Have). Note: Need to Have requirements are essential to progress your application further. 

The Selection Committee will therefore assess eligible candidates using solely the information provided in the responses to those questions. 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, the selection committee will first assign each question a weighting that reflects its relative importance, and each of your responses will be awarded points (1 to 10). The points are multiplied by the weighting factor and added up to identify those candidates whose profiles best match the duties to be performed.

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.

X

Assessments

X

Next steps of selection may include a preliminary assessment (Webex,remote test, etc.) and / or an interview and a test. Please note that due to current travel restrictions the assessment will be conducted remotely. All assessments are based on the assessment criteria listed in this vacancy notice.

At this stage, the selection committee will also look at the other sections of your application form (work experience, education, etc.).

Candidates will participate in cognitive (e.g. deductive reasoning) and personality assessments (e.g. SHL occupational personality questionnaire OPQ32) as part of the selection process.

 

X

Reserve list and job offers

Following the assessment stage(s), the selection committee recommends the most suitable candidate(s) to be placed on a reserve list for future recruitment.

When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview.

Each interviewed candidate will be notified in writing whether he or she has been placed on the reserve list. This reserve list will normally be valid until the end of the next year full calendar year (the validity period may be extended) (TA). Candidates should note that the placement on the reserve list does not guarantee an employment offer.

More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our careers website.

 

Conditions of employment

X

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates placed on the reserve list.

If you currently hold a different contract, a contract in a different function group or your grade is outside the grade bracket stipulated in the vacancy announcement, you will receive a new contract. Chapter IV of the Rules on Temporary Agents 2f of the CEOS as of 1 July 2015 stipulate that the successful candidate will receive a new contract at the grade advertised and will serve probation.

If you currently hold a contract in a grade and function group corresponding to the grade bracket and function group coherent with the post to be filled, you will also be offered the opportunity to be assigned to the post by means of mobility under the provisions of Article 6(2) of the Rules on Temporary Agents 2f of the CEOS as of 1 July 2015.

If you are successful in the selection procedure and offered a position, you will be informed of the options available to you and asked to make a decision within a given timeframe (usually 10 working days).
 


[1] The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location in Amsterdam, the Netherlands, is 110.3. Please consult the Eurostat and Commission websites for more information on weightings.

 

______________________________________________________________________________________________________

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu

 

© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.

Join us to work for every patient in Europe!

Who we are?

Serving a population of 500 million citizens, we promote and protect public 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. 

What do we offer?

  • Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team
  • Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
  • Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)

Benefits

(applicable only to Temporary and Contract vacancies) 

  • Initial 5 year contract with competitive monthly tax-free salary and household & children’s allowances (where applicable)
  • Privileges for expatriate staff including expatriation and education allowances (where appropriate) and additional home leave
  • Relocation assistance
  • Excellent  health insurance scheme and social benefits
  • Retirement Pension Plan 

Read more about Contracts and Salary

Useful links:

 


Job Segment: Pharmaceutical, Regulatory Affairs, Compliance, Chemistry, Medical Device, Science, Legal, Healthcare