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Senior Nonclinical Project Manager (m/f/d) (DE)

[5908]

Our client 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. It is one of the leading pharmaceutical companies, in particular in the field of niche products. Senior Nonclinical Project Manager (m/f/d) permanent direct employment. Your tasks ·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 our client to qualified research organisations/institutions ·Preparation of nonclinical parts of internal due diligence reports Your qualifications ·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 You will be offered ·Your work-life balance is important to us. Our client offers flexible working conditions with the option of working up to 60% of your hours remotely, 30 annual vacation days and an excellent cafeteria ·Attractive salaries and success-based bonuses for all employees ·Individual training opportunities: Our client´s academy offers a wide range of programmes including leadership training, coaching essentials and language classes ·A funded pension scheme and other social benefits ·Our client cares for our employees beyond the workplace and provides advice on caring for elderly relatives as well as offering counselling and childcare ·Our client promotes sports and activities to improve employees’ health If you feel attracted by this job feel free to get in touch with Bettina Cöppicus at Optares via bettina.coeppicus@optares.de or by phone under +49 441 21879-18

Our client 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. It is one of the leading pharmaceutical companies, in particular in the field of niche products.

Senior Nonclinical Project Manager (m/f/d)
permanent direct employment.

Your tasks
  • 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 our client to qualified research organisations/institutions
  • Preparation of nonclinical parts of internal due diligence reports


Your qualifications

  • 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


You will be offered

  • Your work-life balance is important to us. Our client offers flexible working conditions with the option of working up to 60% of your hours remotely, 30 annual vacation days and an excellent cafeteria
  • Attractive salaries and success-based bonuses for all employees
  • Individual training opportunities: Our client´s academy offers a wide range of programmes including leadership training, coaching essentials and language classes
  • A funded pension scheme and other social benefits
  • Our client cares for our employees beyond the workplace and provides advice on caring for elderly relatives as well as offering counselling and childcare
  • Our client promotes sports and activities to improve employees’ health


If you feel attracted by this job feel free to get in touch with Bettina Cöppicus at Optares via bettina.coeppicus@optares.de or by phone under +49 441 21879-18

map Near Hamburg, Germany date_range 01.03.2023 update Permanent
Medical
Direct contact

Bettina Cöppicus

Teamlead Recruitment
mail bettina.coeppicus@optares.de
phone +49 441 21879-18


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