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Medical Writer Specialist

vor 2 Monaten


Böblingen, Baden-Württemberg, Deutschland Wörwag Pharma Vollzeit

{"h1": "Join Wörwag Pharma as a Specialist Medical Writer", "p": "At Wörwag Pharma, we are looking for a highly skilled Specialist Medical Writer to join our team in Böblingen, Germany. As a Specialist Medical Writer, you will be responsible for preparing parts of eCTD dossiers, reviewing and evaluating clinical and non-clinical documents, and collaborating with Regulatory Affairs and Global Pharmacovigilance teams.", "ul": [{"li": "Collaborate with cross-functional teams to prepare high-quality eCTD dossiers for marketing authorizations in Europe and globally."}, {"li": "Review and evaluate the accuracy, consistency, and plausibility of externally produced clinical and non-clinical documents."}, {"li": "Develop and maintain high-quality information texts for medicinal products and food supplements."}, {"li": "Interface with Regulatory Affairs and Global Pharmacovigilance teams on medical/scientific issues."}, {"li": "Edit and review technical information and directions for use, ensuring medico-scientific relevance."}, {"li": "Collaborate with the manager of the Generic portfolio to maintain up-to-date and compliant Generics PILs and SmPCs."}, {"li": "Serve as a contact person for regulatory authorities and internal customers on non-clinical and clinical questions."}, {"li": "Ensure compliance with internal deadlines and quality specifications for the above-mentioned processes."}], "h2": "What We Offer", "ul": [{"li": "A dynamic, international environment with opportunities for growth and development."}, {"li": "Varied challenges and exciting projects with a strong team spirit."}, {"li": "Competitive compensation and benefits package, including flexible trust working hours and mobility allowances."}, {"li": "A wide range of opportunities for personal and professional development."}, {"li": "Regular employee events and a healthy work-life balance."}], "h2": "Requirements", "ul": [{"li": "Successful completion of scientific studies or a comparable scientific education."}, {"li": "Several years of professional experience in Medical Affairs (Medical Writing) and/or Regulatory Affairs/Regulatory Medical Writing."}, {"li": "Proven ability to produce high-quality written documents and check technical content."}, {"li": "Excellent communication and assertiveness skills, with German as a native language or equivalent and very good English skills."}], "h2": "About Wörwag Pharma", "p": "Wörwag Pharma is a medium-sized, internationally active, family-owned pharmaceutical company headquartered in Böblingen, Germany. We have been fighting civilization diseases for over 50 years, and our slogan "Getting closer helping better" reflects our commitment to our employees, customers, and the community."}