Full-time Medical Expert (m/f)

at Daiichi Sankyo in Munich

Key responsibilities:

Responsible for the strategic development of interventional (phase IIIB/IV) and non interventional trials
Medical supervision of interventional and non interventional studies and provision of input to the preparation of the relevant safety documents.
Contact person for international project leaders for medical questions
Participation in study related meetings (Investigator meetings) were medical expertise is required
Participating in global meetings to act as the medical expert regarding the planning, execution and reporting of interventional (Phase IIIB/IV) and non interventional studies
Review of medical documents for submission to authorities/regulatory bodies and Ethical Committees
Act as the medical monitor for interventional studies
Contact partner for internal stakeholders in terms of study related issues as the medical expert
Act as an interface between DSE and Daiichi Sankyo Affiliates within Europe
Training of internal CRAs regarding therapeutic areas and corresponding safety requirements
Identification and evaluation of Investigator Initiated Trials (IITs)
Support the preparation of global and Pan European publications
Close collaboration with Medical Affairs assuring that study designs meet the global medical affairs requirements

Professional and personal skills:

A graduate degree medical doctor (MD), with at least 6 years relevant clinical and scientific experience in clinical research and international project management. A Life Sciences degree with Ph.D. will be considered if relevant experience in clinical research is available
A strong understanding of regulatory environment, thorough knowledge of Clinical Research Principles, ICH –GCP , EU regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to clinical research is given. You are familiar with local regulations for non-interventional studies within EU
Knowledge of pharmaceutical business and international drug development
Strong sense in decision making and problem solving based upon thorough analytical skills as well as sound judgment
Pro-active and self-motivated personality and enthusiasm to work within intercultural teams
Excellent presentation & communication skills - combined with a strong stakeholder focus
Fluent written and spoken English knowledge

We offer:

You will be offered a challenging environment, where you will have the opportunity for personal growth. A comprehensive, attractive and competitive remuneration package will be discussed personally.

Please send us your CV and letter of interest using the online application option below.

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Published at 23-04-2012
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