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Medical Writer for regulatory documents m/f Boehringer Ingelheim ranks among the world\'\'s 20 leading pharmaceutical corporations. Our vision drives us forward. It helps us to foster value creation through innovation in our company and to look to the future with constantly renewed commitment and ambition. Boehringer Ingelheim Pharma GmbH & Co. KG in Biberach is the most important research and development site of the worldwide Boehringer Ingelheim Corporation and the companys centre for biotechnological development and manufacture. Medical Writer for regulatory documents m/f Job ID: 4002 4476 BC 03/10 2 Standort: Biberach Unternehmensbereich: Forschung und Entwicklung Boehringer Ingelheim Pharma GmbH & Co. KG The Medical Writing group fulfils a central service function within the Clinical Research Department of the Boehringer Ingelheim Pharma GmbH & Co KG. We are located in Biberach/Riss, in the South of Germany. We offer a permanent position for a Medical Writer to work in a broad spectrum of therapeutic areas such as oncology, metabolism, respiratory, cardiovascular diseases, virology, immunology, and central nervous system disorders. The position is open for both candidates with limited experience and for more experienced Medical Writers. The focus and the realm of responsibilities will depend on the level of experience of the candidate. Your varied duties will include Writing and management of clinical trial reports of all phases according to ICH/GCP guidelines Writing and management of clinical submission documents in CTD format Review of statistical analysis plans and clinical trial protocols Management and supervision of external Medical Writers and CROs Training of Medical Writers Close interaction with other functions within clinical research and other relevant departments on an international level Planning and management of publication activities for entire clinical development projects The suitable candidate should have the following qualifications Graduate scientist in a life science (biology, chemistry, pharmacy, animal or human medicine), preferably at PhD level At least 2 years of experience in clinical research and a basic understanding of the pharmaceutical development process Hands-on experience in writing and editing of medical or scientific texts Excellent command of English and a good knowledge of statistics Ability to convert medical scientific data into concise and easy-to-read documents with great attention to detail Willingness and ability to work in a team and to take over responsibilities Open-mindedness and strong organisational and communication skills For a more senior level, the applicant should have at least 3 years of experience in the writing of regulatory documents within a pharmaceutical company or CRO. He or she needs to have demonstrated hands-on writing experience with global submission projects. If you are looking for an opportunity to work in a highly interactive international environment and to expand your professional horizons in a dedicated team of medical writers, we look forward to hearing from you. Do you have further questions? Your contact persons: in the Medical Writing Group, Dr Thomas Schindler, +49 (0) 73 51 / 54 92 292 in the personnel department, Christine Rechtsteiner, + 49 (0) 73 51 / 54 57 72 As a company without barriers, we welcome applications from the severely disabled if they have the relevant qualifications. Please submit your application online - quoting the code 4002 4476 BC 03/10 2 or by email to christine.rechtsteiner@boehringer-ingelheim.com Apply online © 1999 - 2010 Boehringer Ingelheim Pharma GmbH & Co. KG, Deutschland. Alle Rechte vorbehalten.
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