![]() Interprets literature information and makes recommendations for application to clinical regulatory documents. Performs literature searches as needed for drafting document content.Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.Independently resolves document content issues and questions. Confirms completeness of info to be presented. Verifies that results are consistent with protocols. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors.Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals. ![]() Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.). Holds team members accountable to agreed-upon project dates. Responsible for effective communication among team members.Ĭommunicates deliverables needed, writing process, and timelines to team members.Ensures required documentation is obtained. Arranges and conducts review meetings with the team. Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects. Explains data in manner consistent with clinical regulatory requirements. ![]() ![]()
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