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Task description and requirements

Tasks:
1.Responsible for planning and preparing high quality medical writing deliverables and disclosure/transparency activities (e.g., study protocols, clinical study reports, statistical analysis plans, Investigator Brochures, relevant modules of regulatory dossiers, Plain Language Summaries, Results Summaries for disclosure, briefing books).
2.Participates in the development of Best Practices, SOPs work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables
3.Provides input into the strategy for medical writing vendor selection, defines the scope of work to be outsourced and is responsible for medical writing vendor management.
4.Responsible for continuous improvement of in-house medical writing

Qualification:
•A solid understanding of the Clinical Development Process, including the documents that are required at each stage of development
•An excellent understanding of all aspects of ICH GCP, SOPs, and international publication pl

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