Global Medical Writer

vor 2 Wochen

Wien, Wien, Österreich Octapharma Pharmazeutika Produktionsges.m.b.H. Vollzeit

Global Medical Writer - Transparency Manager (m/f/d) Job-ID: 59659 Location: Wien, AT Job Level: Professionals Department: Research and Development Working time: Permanent position, Full-time (38 hours) Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are now hiring for our team: Your new challenges which will inspire you: * Write, review and coordinate the preparation of documents under the responsibility of medical writing department * Editorial and quality control review of documents prepared by external medical writers * Ensure that all deliverables are provided on the appropriate milestone date * Collaborate with other functions concerning safety issues relative to safety writing activities such as pharmacovigilance personnel, medical reviewers, clinical department, products quality, regulatory affairs and marketing * Participate in ongoing safety data review and analysis for products in designated therapeutic areas * Contribute to the review and development of existing and new SOPs and provide input or write/update and review SOPs * Ensure archiving and traceability of all activities * Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities and Clinical Regulatory Documents * Preparation and review of response documents to specific requests from regulatory/health authorities * Redaction of documents requested by regulatory authorities for publishing * Disclosure of studies and results on Clinicaltrials.gov and EudraCT Your profile that will convince us: * Completed academic degree, ideally in a medical or healthcare * Experience in pharmacovigilance, medical writing and preparation of safety documents would be an advantage * Experience with CTIS or other data bases for redaction of PPD and CBI would be an advantage * Very good verbal and written English skills as well as communication and presentation skills * Team player with a strong focus on timelines * Good level of computer literacy, in particular in the use of databases, MS Word and MS Excel * High degree of accuracy with attention to detail * Excellent critical, analytical and problem-solving skills Our attractive benefits for you: * Wide range of tasks in an international setting, flexibility and personal responsibility * Reliable employer with generous employee benefits and a salary customary in the market. * Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more: Additional information: The minimum gross wage according to the collective agreement (chemical industry) for your new job is EUR 4.157,14. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed. Your contact: Johanna Proksch, MAOctapharma Pharmazeutika Produktionsges.m.b.H.Oberlaaer Straße 235, 1100 Wien,T: +43 (1) 610 32 - 4299 About Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.Octapharma employs around 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care.Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 180 plasma donation centers across Europe and the US.Fore more information, please visit www.octapharma.com.

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