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CMC Technical Writer (m/w/d) in Munich

CMC Technical Writer (m/w/d) in Munich

Job Title: CMC Technical Writer (m/w/d) in Munich
Contract Type: Permanent
Location: München, Bayern
Industry:
Salary: €60000 - €90000 per annum + negotiable
Start Date: ASAP
Reference: RA_2020_12_1583751332
Contact Name: Sebastian Gotzler
Contact Email: s.gotzler@sciproglobal.de
Job Published: March 09, 2020 10:55

Job Description

CMC Technical Writer (m/f/x) in Munich

Is strong team spirit very important to you? Are you an enthusiastic natural scientist and have a fable for meticulous and super-precise work? Your fingers tingle when you hear the word drug approval? Can you identify yourself with the role of supporting the quality experts by writing core quality sections for chemical, biological, cell-based and gene therapy products? If you feel like experiencing this with an international and leading consultancy offering a wide range of services in the field of regulatory affairs, then you've come to the right place!

What are your tasks & responsibilities as CMC Technical Writer?

  • Review of GMP source documents such as batch records or validation reports
  • Authoring and review and of high-quality reports, such as comparability reports
  • Authoring and review of documents for CTD Modules 1, 2.3 and 3 for IMPDs/INDs and MAAs/BLAs/NDAs
  • Authoring of documentation to support regulatory agency meetings in the US and EU (briefing books, presentations)

Which requirements are needed as CMC Technical Writer?

  • D. or master's degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable
  • At least 3 years' experience in technical CMC writing, thereof at least 2 years' authoring experience for INDs, IMPDs, BLAs, NDAs or MAAs
  • Knowledge of technical/regulatory requirements for at least one of the product classes listed above
  • Excellent writing and communication skills in English. German language skills are a plus
  • Sound knowledge of Microsoft Office applications

What can you expect as CMC Technical Writer?

  • Professional and friendly working environment
  • Modern office space in the south of Munich
  • Working with a dedicated small and effective team
  • Very competitive salary
  • Attractive bonus system tailored to your expertise and business success

About the client?

Our client is a leading consultancy for regulatory affairs, supporting small and big biotech and pharmaceutical companies in all phases of drug and device development, from defining the right strategy to submitting the marketing authorisation application, regulatory maintenance etc. All consultants have gained many years of experience within the industry and have know-how and proficiency in the various disciplines required for drug development. The company was founded in 2002 and delivered quality service to more than 500 clients in Europe, North America, Japan, Australia and Asia.

Contact for application: