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Name Of the Company : Debiopharm Group
Company Location : Lausanne
Country : Switzerland
Senior Scientific Officer – Personalised Medecine :
You will report to the Director, Personalised Medicine
Your main responsabilities :
** Partner with preclinical pharmacology during the pre-clinical stages of drug development to help develop a biomarker strategy to support early clinical development
** Provide biomarker input into the overall Translational Medicine Plan
** Participate in pharmaceutical development project teams and drive companion diagnostics discovery and development, particularly regarding development strategy, budget, risk management and operational implementation
** Establish partnerships in the following field in collaboration with the head of Personalized Medicine
** Diagnostics relevant to companion diagnostics discovery and development
** External experts in personalized medicine
** Contribute to increase understanding and knowledge of personalized medicine within Debiopharm
** Follow the external evolution of diagnostics, clinical development and commercialization fields related to personalized medicine.
Your profile :
** PhD related to life science
** Experience in pharmaceutical product development in pharmaceutical or biotechnology industry with a deep knowledge in the field of biomarkers, personalized medicine and companion diagnostics
** Significant experience in matrix organization within product development project teams with strong capabilities in planning, implementation and priority management
** Excellent teamwork and good communication skills within a matrix environment
** Strategic thinking capabilities
** Willingness to discover and integrate new paradigms and technology, with a strong innovation capability.
Debiopharm can offer you :
** An international and highly dynamic environment.
** The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
** The possibility to be in a company in which Innovation, People and Entrepreneurship are the fundamentals of its success.
Regulatory Affairs Specialist :
Your tasks :
** You will be responsible for leading technical activities linked to the maintenance of marketing authorizations (variations, renewals, etc…) in Switzerland and the EU. In addition, you participate in the preparation and review of new applications and variations
** As support of the Regulatory Affairs Managers, you will be involved in the preparation of clinical trial application dossiers for products under development
** You will also be responsible for writing regulatory standard operating procedures.
Your profile :
** Degree in Pharmacy, Medicine or Life Sciences, preferably at PhD level
** 1-2 years of experience in regulatory affairs and/or an advanced degree in regulatory affairs
** Knowledge in the preparation and review of variations and renewals
** Knowledge in the preparation and review of Clinical Trial Application and/or US INDs would be an asset
** Excellent team-working and interpersonal skills, with the flexibility to actively contribute within multidisciplinary and multicultural teams
** A high degree of self-motivation, coupled with a positive and proactive approach
** Computer literacy is essential
** Excellent written and communication skills in English and French.
How to Apply : Apply through the form given against each job in the official website
https://www.debiopharm.com/careers.html
Contact us :
Debiopharm Group
Chemin Messidor 5-7
Case postale 5911
CH-1002 Lausanne