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Collaborating Expert - Intercurrent events related to Covid-19 in MAAs

Type of position:  Expert
Job Type:  1 November 2022 23:59 CET

Organizational Unit: Data Analytics and Methods Task Force 

                                   Methodology Office

Proposed length: 12 months (extendable if needed). This position is part-time. The successful candidate will be able to dedicate 16 hours per week to the collaboration.

Place of work: Remote.

Remuneration: Experts should be salaried by their employer or be a post-graduate student (financed by their educational entity or self-financed).  It is therefore not remunerated by the EMA but the Agency will agree reimbursement of reasonable expenses (accommodation and travel) where necessary.


 

The European Medicines Agency is a decentralized body of the European Union with all its offices and Headquarters based in Amsterdam, the Netherlands. Its core responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines.

 

The Collaborating Expert Programme is addressed to scientists and professionals who can share their expertise in a particular area of European Medicines Agency’s activities or are interested in collaborative research projects related to EMA’s scientific work.

 

The aim is to provide a mechanism for EMA and external researchers to collaborate in identifying and tackling important research questions to support regulatory decision-making.

 

This will help ensure that regulatory science remains at the cutting edge so that EMA can deliver its fundamental mission of protecting human and animal health and facilitating the availability of medicines to patients.

 

This announcement is governed by the Policy 0080. For further information please visit our Collaborating Expert Programme website.

Strategic area/objective

RSS goal 2.

Driving collaborative evidence generation – improving the scientific quality of evaluations

RSS recommendation

Expand benefit-risk assessment and communication

RSS underlying action

Enhance structured assessment of benefits, harms, and uncertainties to improve communication to the public;

Specific projects

Covid-19 has impacted ongoing trials intended as pivotal evidence for MAAs, and the estimands concept introduced by the ICH E9 R1 addendum can be used to both describe the impact, and discuss how to handle the intercurrent events (e.g. change in measurement technique from in-person to remote due to social distancing measures introduced in reaction to the pandemic). To increase the understanding of the impact of Covid-19 on clinical trials intended as pivotal evidence for drug licensing decisions, this project aims to:

 

Conduct a review of marketing authorization applications that include pivotal trials affected by Covid-19 and identify

a) Intercurrent events related to Covid-19 that have been relevant for the respective trial interpretation

b) the strategy for handling these intercurrent events and

c) the statistical methodology used as an estimator to address the estimand of interest

Deliverables

  • Study outline that operationalises the research question and defines the types of licensing procedures to target and the method for identification (intermediate deliverable, internal)
  • Presentation on research methodology and results (internal)
  • Scientific publication in peer-reviewed journal on aggregated results (final deliverable, public)

Benefits for the expert

  • Joint research undertaking and joint publication
  • Share your academic knowledge and perspectives and contribute to the Agency’s efforts understanding of the impact of Covid-19 on clinical trials
  • Contribute to the implementation of estimands in regulatory practice
  • Gain experience of working in an EU organisation and of the EMA’s work and role in regulatory science. 

 

Benefits for the collaborating institution

•    Exchange of knowledge and expertise 
•    Joint research undertaking, and if publication, joint publication
•    Building a personal and inter-institutional collaboration with EMA

 

Essential requirements

Essential:

  •  Experience with interpretation and application of the estimand concept as defined in the ICH E9 R1 addendum
  •  Research and analytical skills
  •  Excellent written communication skills

 

Desirable:

  •  Demonstrated experience with empirical research
  •  Demonstrated experience in writing, analysis and reporting of results

Behavioural competencies:

  • Communication skills
  • Interpersonal skills
  • Working with others
  • Adaptability
  • Learning and development

______________________________________________________________________________________________________

 

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 

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