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Medical Technical Writer
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- Manages all technical aspects of GMW document development as well as publishing and archiving activities and is the interface to Global Regulatory Operations.
- Accountable for Patient Narrative process and final delivery including coordinating the strategy, overseeing the process, managing timelines with cross-functional teams, and interfacing and overseeing the vendor to ensure timely and successful document finalisation.
- Responsible for the preparation of relevant content for global clinical documents (CTPs, IBs, CTRs, ICFs, or other relevant clinical documents) including the planning and set up in the document management system for authoring teams, the planning and strategy for document development, and the overseeing of timelines.
- This may include the set-up, organization, and standard content management for various document types as well as overseeing and managing the publishing and archiving activities for global clinical documents managed by GMW. The Medical Technical Writer serves as the interface between GMW and Global Regulatory Operations.
- Ensures quality of the deliverables that are outsourced to vendors/CROs that are writing clinical trial reports or other clinical regulatory documents and acts as the interface to BI systems that are not accessible to external vendors.
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