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Scientist - Medical Technical Writer, Clinical Studies (m/f/d) job in Bergisch Gladbach bei Miltenyi Biotec B.V. & Co. KG

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Scientist - Medical Technical Writer, Clinical Studies (m/f/d) bei Miltenyi Biotec B.V. & Co. KG

Scientist - Medical Technical Writer, Clinical Studies (m/f/d)

Miltenyi Biotec B.V. & Co. KG Bergisch Gladbach, Nordrhein-Westfalen Vollzeit
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Medical Technical Writer (m|f|d)

The company

Miltenyi Biomedicine is a newly established international biopharmaceutical company that develops innovative cell and gene therapies. We are focused on bringing cancer treatments and regenerative therapies to patients. Our initial focus is on difficult to treat hematological cancers using CAR-T technology whilst exploring treatments for solid tumors. We are currently in discussion with the FDA, EMA and Japanese health authorities regarding initiating pivotal Phase II trials. We strongly believe that despite promising developments, there is significant room to improve on current cancer therapies.
Your role
As a Medical Technical Writer you are responsible for writing of submission relevant documents, which include among others Module 5 sections and Module 2 (i.e. clinical summaries and overviews) in CTD format for submission to FDA and EMA, study reports, answer questions related to Module 5 and pediatric plans (PIP) and orphan maintenance reports.
  • You oversee clinical study protocols, clinical study reports, and investigators brochures.
  • In cross-functional working groups you contribute to the overall project management to facilitate efficient development and finalization of regulatory documents for submission.
  • Writing up CMC documents and reports from different suppliers and sources of data will also be your task.
  • You will be a part of our Miltenyi Biotech Biomedicine branch working in the Team that is responsible for Regulatory Affairs in EU.
Your profile
  • You hold a bachelor or master degree in a scientific study program or you finished a scientific/technical apprenticeship with success.
  • A minimum of 2 years’ experience in Regulatory Medical Writing is mandatory.
  • A solid knowledge about CTD documents, clinical study reports, study protocols, and investigator brochures is needed Further you should have experience in writing the SmPC or PI in generell.
  • You have an excellent time and priority management and work efficiently.
  • You are a strong communicator and are fluent in English (written and spoken).
What we offer
  • A modern workplace and exciting opportunities in the development of technologies with a secure future
  • Cross-border intercultural cooperation and short communication channels
  • A collegial corporate culture and flexible working hours enable time management on your own terms
  • Personalized employee development program: specialist and personal training courses provided by our own training academy
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Job ID: 158488