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CMC Documentation Specialist

With your experience within a pharmaceutical environment (GMP) and knowledge of CMC documents, you want to be a key player in the registration process of novel vaccines during (clinical) development and preparation for future commercialization.

Functie omschrijving

As CMC Documentation Specialist you will work at the department that focusses on dossier development, e.g. technical editing, proofreading, and formatting CMC dossiers according to the Document Standards and GMP guidelines. You provide resources, support, and coaching to CMC Scientists in the editing of CMC sections of clinical and marketing applications (new and amendment/supplement/variation).
Your Main Tasks and Responsibilities will be:
  • Produce high quality submission deliverables, meeting aggressive timelines, using electronic document management systems.
  • Assist Technical Writers in the formatting of submissions. Serve as a role model to the global CMC documentation community with regard to pertinent software applications.
  • Provide individual instruction or support to authors, when needed, on selective topics involving Microsoft Word, Standards, or the Content Management application.
  • Provides options or alternative solutions to dossier editing/formatting/challenges.
  • Analyze, troubleshoot, define innovative workarounds, and document solutions to software applications
  • Transform technical ideas, thoughts, and discussions into written process documentation. Define and optimize detailed workflows/processes that involve the editing of submissions level CMC documentation.
  • Superior ability to interpret current regulatory agency guidelines and implements into submission documentation.

Profiel kandidaat

  • Bachelor degree and as a minimum
  • Experience in a pharmaceutical environment and good knowledge of GMP
  • Extensive knowledge of the CMC dossier planning and production process and standards
  • General understanding of product development and organizational functions that contribute to the dossier production process
  • Professional proficiency in English

Since different CMC projects are carried out in teams comprising members from different departments, teamwork, good organizational capabilities and flexibility are three very important characteristics that are required attributes.
In your Support role you have excellent communication and soft skills. You will need to effectively communicate with other scientists, management and team members. In your Support role you must be able to work independently but also participate effectively as part of a team in a global environment.

Bedrijfsprofiel

Our client works with its own teams of motivated people with a can-do mentality at the location of clients. These are mostly pharmaceutical companies with an international group of employees. Working together is extremely important and having fun in what you do is of course part of that! There are monthly team lunches, team outings and awards are given to colleagues.

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