To participate and to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development planFunctieomschrijving
To participate to Phase I-IV Clinical Development activities within a program or group of related programs within the context of the company’s Vaccines process in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and the company’s Vaccines standard operating procedures (SOP).
- Participate in Clinical Development activities for a study or a number of studies within a specific program or group of related programs.
- Serves as a scientific and management reference for the project (internally/externally)
- As a member of the Clinical Project Team, always actively participate and engage within the project matrix: Actively participate as a core member of the clinical project team and contribute to the achievement of team objectives; May be delegated by Clinical and Epi Project Lead or Senior CRDL to lead the Clinical Project Team.
- Actively participate in preparing the clinical portion of the regulatory files and the registration process; Contribute to the development of the clinical section of regulatory files, including labelling.
- Provide medical support to Marketing/Business Development throughout product life cycle in order to achieve Company’s objectives.
- Show active follow-up the product-related Environment
- MD certification (mandatory)
- Minimum 2 year industry experience OR minimum 5 years experience working in a scientific or medical institution
- Knowledge and understanding of vaccines, clinical research and biomedical research regulation (including ICH and GCP)
- Working knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape
- Excellent knowledge of spoken and written English
- Sensitivity to the needs of diversified ethnic groups and ability to build rapport across the spectrum
- Strategic thinking skills and achievement oriented
- Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks
- Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences
- Preferred PhD certification
- License to practice medicine and board and/ or professional certification is an asset.
The vaccines, medicines and consumer healthcare products that they research and develop can improve people’s health and well-being, ultimately helping them to live life to its fullest and contribute to the prosperity of their communities.Locatie/Standplaats
Our client will offer a competitive benefits package in line with the seniority of the position.Sollicitatieprocedure
Voor meer informatie neem je contact op met Gyöngyvér Lukács via telefoonnummer 06-10317714
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