Medical Writer m/f for Regulatory Documents Job in Biberach/ Riss 88400, Baden Württemberg Germany
The Medical Writing Europe 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, at the key research and development site of the Boehringer Ingelheim Corporation.
We offer several positions for Medical Writers to work in a broad spectrum of therapeutic areas such as oncology, metabolism, respiratory, cardiovascular diseases, virology, immunology, and central nervous system disorders. The positions are open both for candidates with limited experience and for more experienced Medical Writers.
Initially employment will be limited to 2 years with the option of permanent employment thereafter.
The focus and the realm of responsibilities will depend on the level of experience.
The position entails:
- 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
As suitable candidate you should have the following qualifications:
- Graduate scientist in a life science (biology, chemistry, pharmacy, veterinary 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, you should have at least 3 years of experience in the writing of regulatory documents within a pharmaceutical company or CRO. In addition you need 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.
Offers via recruitment or staffing agencies are not considered.
Do you have further questions?
Your contact persons are:
- in the operating department, Dr Thomas Schindler,
phone +49 (0) 73 51 / 54 92 292 - in the personnel department, Eva Spieler,
phone +49 (0) 73 51 / 54 97 703
As a company without barriers we welcome applications from people with disabilities if they have the relevant qualifications.
We look forward to receiving your online application -
please enter the reference code 4003 8729 BC 03/12 2.