Hays
Bern | Freelance/temporary employment for a project
Reference number
578957/1
Start date
asap
Project duration
6 MM++
My duties
  • Develop the CTA submission strategy for global clinical trials during the whole study lifecycle
  • Act as interface regarding regulatory CTA topics between key functions and key stakeholders as well as authorities
  • Prepare, compile and submit country-specific CTA dossiers
  • Contribute to or review key documents such as Clinical Study Protocols, Investigators Brochures, Investigational Medicinal Product Dossiers, IMP-Labels and Development Safety Update Reports
  • Prepare and approve CTA dossiers
  • Manage Clinical Trial Projects/ activities and ensure documentation
  • Work closely with Regulatory teams and Global Regulatory Affairs as well as the study teams
  • Liaise with and act as first point of contact regarding CTA related topics for all stakeholders (GRA, R&D, CO, PV, PM, QA, Legal)
  • Manage interactions between the company and competent authorities
  • Ensure tracking and documentation of CTA activities 
  • Improve processes, procedures, concepts and systems regarding CTA
  • Use synergies to ensure timely CTA approvals 
  • Oversee all activities that are outsourced to CRO's
  • Act as Expert for all CTA-related topics (requirements, regulations, operations, implementations, benchmarking, knowledge databases, standards)
  • Lead a Regulatory-Execution Team 
  • Plan and prepare CTA-related SOP's and working practices
My qualifications
  • A degree in life science, pharmacy, medical laboratory technology or other health/medical related area.
  • Experience in managing Clinical Trial Authorizations
  • Experience in working with or working within a Contract Research Organization (CRO)
  • Knowledge of regulatory requirements and ICH guidelines/ GCP
  • Experience in scientific/medical research
  • Project management skills
  • Excellent written and oral communication skills in English – German is a plus
My benefits
  • A very renowned company
About Hays
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays

My contact person
Marc Peter Linder

Reference number
578957/1

Contact
E-Mail: marc.linder@hays.ch