Senior Medical Writer (m/f/x)
Bayern
Senior Medical Writer (m/f/x) | Bavaria |Pharma This role focuses on creating medical documentation throughout all development phases for small molecules, biologics, cell-based, and modern targeted/personalized therapies. What will your tasks as "Senior Medical Writer (m/f/x)" be?Set up medical documentation for all development phases of small molecules, biologics, cell-based, and modern targeted/personalized therapies.Develop and draft essential documents required during the clinical development stage, such as clinical study protocols, investigator brochures, clinical study reports, and publications.Draft a variety of high-quality regulatory documents needed for marketing applications, such as non-clinical and clinical summaries, clinical overviews, risk management plans, product information documents, and responses to inquiries from regulatory agencies.Perform strategic gap analyses of draft regulatory documents and clinical data packages and conduct critical literature searches to support and strengthen the messaging.Document and support agency meetingsPrepare documents aimed at expediting drug development and approval, such as Fast Track and Breakthrough DesignationGenerate additional documents as needed for specific projects, such as Orphan Drug Applications, Diversity Plans, and Pediatric Investigation Plans.Collaborate closely within cross-functional project teams, both internally and with clients. Your requirements as a "Senior Medical Writer (m/f/x)"?Master's degree in Life Science or Medicine or veterinary medicineExtensive experience in medical writing (preferably over 10 years) covering a wide range of regulatory documents.Thorough understanding of EMA, FDA, and ICH regulations and guidelines.Ability to work independently, analyze and summarize data (clinical, non-clinical, quality).Excellent written and oral communication skills in English, German as a second language is a nice to haveCapability to handle multiple tasks concurrently while meeting tight deadlines. What does the role as "Senior Medical Writer (m/f/x)" offer to you?Relocation support is available, including assistance with accommodationHybrid working model with 40-60% home office possibleOpportunities for professional growth by exposure to a wide range of innovative projects, focusing on expanding specialist skills rather than advancing to higher managerial levels.The role does not include client acquisition responsibilities.Are you interested in this position? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!My contact details:Email: inderhees@sciproglobal.deTel: +49 089 26 20 09 25I look forward to your application!