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The Medical Writer is a member of the Clinical Team. He/she is responsible for the production of key documents related to CD&MA activities (e.g. protocol, ICSR, IB, publications, etc) in line with the Company as well as external standards, e.g., regulatory requirements or journal guidelines
1. Participates as a member of the Clinical Team accountable to the Clinical Team Leader for all project issues. Responsible for the production of the key documents related to CD&MA activities, in line with the Company document standards. Documents written include study protocols, ICSR, Clinical Expert Reports, publications, ISS, and ISI.
2. The Medical Writer organizes and coordinates the meeting of the Document Review Committee for the timely review and approval of concept protocols; and the meeting of the Clinical Team for the review and approval of the full protocol.
3. The Medical Writer will collaborate with other team members to ensure that the relevant function representative produces appropriate sections according to specific needs of the project and nature of the document. Coordinates input from expert contributors to these documents, and will deliver reports to agreed project plans.