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    • Technical Writer and Document Workflow Manager - Basel - Actalent

    Actalent
    Actalent Basel

    vor 2 Monaten

    CHF104,000 - CHF130,878 (CHF) pro Jahr *
    Beschreibung

    We are currently looking for a
    Technical Writer and Document Workflow Manager
    to support the development of parenteral drug products—from early clinical phases through to commercial launch. This role is central to ensuring high-quality documentation for process validation and regulatory submissions, transforming complex scientific data into clear, structured content for global health authorities and internal stakeholders.

    Responsibilities

    • Author, review, and format process validation protocols, reports, and regulatory documents (e.g., INDs, IMAs).
    • Interpret process validation data to support documentation efforts.
    • Compile and organize supporting data to ensure accuracy, completeness, and consistency across validation and regulatory packages.
    • Manage multiple projects and timelines in collaboration with project managers.
    • Coordinate process validation study documents and regulatory submission sections across project teams.
    • Act as a "Superuser" for IT tools supporting document workflows and process knowledge management (e.g., Veeva Quality Docs, Veeva RIM, eVAL, Basecamp2.0).

    Must-Haves

    • Bachelor's or Master's degree in a scientific discipline.
    • Minimum 2 years of experience in parenteral drug product aseptic process development and/or process validation, with strong familiarity with technical terminology.
    • 2–5 years of experience in technical writing; experience with regulatory documentation is a plus.
    • Excellent command of English, both written and verbal.
    • Strong proficiency with IT tools for text processing, flow diagrams, spreadsheets, and validation documentation workflows.
    • Ability to quickly grasp complex scientific concepts and convert them into high-quality summaries and reports.
    • Strong organizational, communication, and time management skills to manage multiple concurrent projects.
    • Self-motivated and capable of working independently.
    • Team-oriented with flexibility in prioritizing tasks and finding solutions.

    Location:
    Basel

    Duration:
    12 months

    Start date:
    ASAP

    If you want to learn more about this opportunity please feel free to reach out directly to

    *While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.

    * Diese Gehaltsspanne ist eine Schätzung von beBee
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