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    Senior Nonclinical Project Manager (m/f/d)

    from:
    EG10
    medac is a dynamic company that has been growing continuously for over fifty years. More than 2,000 employees work on the further development of medical products and medical devices for the diagnosis and treatment of oncological, urological and autoimmune diseases. We are one of the leading pharmaceutical companies, in particular in the field of niche products.
    • Conception and management of nonclinical drug development programs and life-cycle activities according to appropriate governmental and regulatory requirements (like GLP/ICH, OECD, EMA, FDA) and company's SOPs and development strategy
    • Preparation of relevant nonclinical regulatory documents in the course of nonclinical and clinical development of investigational new drugs as well as in the context of generic, bibliographic or full dossier submissions for marketing authorization
    • Evaluation of scientific publications and other pharmacological/toxicological reports regarding their relevance for revision/rewriting of existing nonclinical documentations such as nonclinical parts of development plans, briefing books for scientific advice, target product profiles, investigational medicinal product dossiers, investigator brochures, developmental safety update reports, periodic safety update reports, orphan drug applications, paediatric investigational plans, CTD modules 2.4, 2.6 and 4
    • Independent co-ordination and oversight of the conduct, analysis and reporting of nonclinical in vitro and in vivo studies contracted by medac to qualified research organisations/institutions
    • Preparation of nonclinical parts of medac-internal due diligence reports


    • University degree (PhD, MD, PharmD or DVM) in biology, chemistry, medicine, pharmacy or veterinary medicine
    • Appropriate training and experience in the field of pharmacology/pharmacokinetics/toxicology
    • Knowledge regarding international guidelines for preclinical drug development and non-clinical dossier structure (CTD) for pharmaceuticals
    • Demonstrated experience from previous work in pharmaceutical industry; communication with health authorities; understanding of regulatory submission components (including IB, IMPD, DSUR, PSUR, SA, PIP, CTA, MA)
    • Fluent English (oral and written)
    • Detailed knowledge of MS Word, Excel, PowerPoint, MS-Project
    • Team spirit, dedication and sense of responsibility as well as an independent and reliable way of working
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