id: MDMxMzE5MDQwMDA5MDEgMjYx

reference: 03131904000901

documentId: 03131904000901

connectionPointId: 261

Stillingstittel:
PhD Fellowship in International Research Ethics - Regulatory Ethics

Stillingsbeskrivelse:

Jobbnorge ID: 168348

Job abstractJV_description

One position as PhD Research Fellow in International Research Ethics is available at Centre for Medical Ethics (CME) at the Institute of Health and Societyat the University of Oslo.

The successful PhD candidate will be part of an interdisciplinary research group at CME focusing on International research ethics, global health and human rights, and he/she will be involved in the project Incorporation of Ethics in Pharmaceutical Authorization Regulatory Procedures (Regulatory Ethics) . Good Clinical Practice and European Medicines Agency (EMA) documents require clinical trials to be conducted in accordance with ethical principles and that major ethical flaws should have an impact on the final conclusions about approvability of an application. In spite of these requirements, clinical trial regulators frequently encounter ethical issues through the post-clinical trial inspection reports (from several parts of the world, including low and middle income countries) that are submitted to the EMA for the marketing authorization application of a new medicinal products. At the same time, these ethical issues never reach the marketing authorization deliberation processes.To address the gap between what is ethically required and the reality outlined above, this project will investigate how ethics should and could be incorporated in the regulatory procedures leading to marketing authorizations of medicinal products (main objective). The specific aims are:

1. To perform a systematic review of reasons on the place of ethics in the regulation of clinical development programs;

2. To identify regulatory options for action on ethically relevant Good Clinical Practice violation findings;

3. To explore the opinions of relevant stakeholders on what regulatory ethical responsibility means, what it consists of, who ought to be responsible and what the possible courses of action might be given specific types of ethical issues;

4. To develop a normative framework on the ethical responsibility of regulators;

5. To provide recommendations on how ethics should be incorporated in the regulatory procedures leading to marketing authorizations.

The Centre welcomes proposals demonstrating the candidate's suitability to address issues highlighted in the above mentioned project abstractJV_description (Regulatory Ethics).

Starting date has to be September 15 2019 at latest.

More about the position

Positions as research fellows are fixed-term educational position for a periode of three years where the aim is that the research fellow completes a doctoral degree (PhD) during the period of employment. A prerequisite for the employment is admission to the Faculty's doctoral degree program, and applicants' formal and other qualifications for admission will therefore also be assessed. Research fellowship positions are defined as recruitment posts and represent an important instrument in the sector's work of generating qualified applicants for other academic posts at universities and university colleges in the long-term perspective.

The doctoral candidate is expected to participate actively in the organized research training and in the Faculty's research community.

We refer also to Guidelines concerning appointment to post doctoral and research posts at the University of Oslo.

Qualification requirements

Applicants must satisfy the requirements for admission to the Faculty's PhD program. This includes:

• Successful completion of an MD degree, or a Master's degree with thesis, or equivalent qualifications, with sufficient relevance to the announced research field
• Minimum grade B (ECTS grading scale) or equivalent on the Master's degree, and explicit indication of the grade achieved on the thesis part.
• The successful candidate will have background in medicine or pharmacy, and/or a master's degree in a relevant health or social science programme, as e.g. health care ethics and law.
• Excellent knowledge of everyday and academic English is a requirement.

Personal skills

In the assessment of applications, emphasis will be placed on

• The application's compliance with the main objective and specific aims of Regulatory Ethics.
• The applicant's personal suitability and motivation for being involved in the research project, and to form part of a cross-disciplinary academic community.

We offer

• salary in line with pay grades 51 - 58 (NOK 449.400,- - 505.800,- per annum depeding on qualifications in position as PhD candidate (position code1017)
• a positive and challenging working environment
• pension arrangements in the Norwegian Public Service Pension Fund
• a position in an inclusive working life enterprise
• attractive welfare arrangements
• The University of Oslo has an Acquisition of Rights Agreement for all employees for the purpose of securing intellectual property rights to research results etc.

How to apply

The application must be submitted electronically and must include the following:

• Letter of application and project abstractJV_description of 2-3 pages
• Certified copies of diplomas, grade transcripts and any other testimonials
• List of referees, minimum 2 persons, with contact information; email and telephone numbers
• In the event of diplomas from other countries: printouts of prospectuses or similar that describe the content and framework of the courses of study on which the application is based.
• CV that also includes an overview of any previously published academic/scientific works.
• Applicants from countries outside the Nordic countries where English is not the official language must attach a TOEFL test with a minimum score of 550 unless they have a diploma from a university in an English-speaking country.

Incomplete applications will in normal circumstances not be assessed.

Formal regulations

Please see theguidelinesand regulations for appointments PhD positions at the University of Oslo. No one can be appointed for more than one specified period at the same institution.

According to the Norwegian Freedom and Information Act (Offentleglova) information about the applicant may be included in the public applicant list, also in cases where the applicant has requested non-disclosure.

The University of Oslo has an agreement for all employees, aiming to secure rights to research results etc.

The University of Oslo is an equal opportunity employer and strives for diversity.

The University of Oslo also aims to recruit more individuals with an immigrant background to academic positions. Candidates with an immigrant background are encouraged to apply.

Contact information

Questions regarding the project and position: Professor Jan Helge Solbakk Telephone: +47 22844641, mobile: +47 99235752 E-mail: j.h.solbakk (at) medisin.uio.no

Practical information regarding the application prosess: HR advisor Åse R. Halfstad Telephone: +47 22850508

Se annonsen og søk på stillingen www.jobbnorge.no

PAM

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2310

abstractJV_contact_0: See jobabstractJV_description

contractTypeCodes_0: fulltime

Arbeidsgiver Navn: Universitetet i Oslo

source: NAV