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. Converts relevant data and information into a form that meets clinical regulatory document requirements.Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve. Provides input and feedback to management regarding internal medical writers' work product/quality. As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product. Serves as a subject matter expert within department for the Aesthetics area.Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US). Works closely with the Regulatory team(s) on document strategies. ![]()
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