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| Associate Director NJ Open (J#27914) Title: Associate Director Company: Volt Description: Associate Director A global leader in the management of infectious diseases has a contract position available for an Associate Director to work on a project as part of a team. Position Description: The Associate Director prepares clinical documents that are of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency, with adherence to regulatory guidelines, company guidelines/styles/processes and standards, within established schedules and timelines. Duties and Responsibilities: * Project Responsibilities * Serve as Lead Medical Writer for Global Virology Medical Affairs studies. Using Company templates and following Company procedures, write protocols and study reports, publications and related documents. (55%) * Take an active role on assigned projects with respect to medical writing, and planning of content, format, and timing of documents, report scheduling/tracking, etc. (15%) * Interact effectively with Team Leaders, Project Physicians, Biostatisticians, Programmers, Regulatory Personnel, etc., and facilitate effective interactions and information exchange/communication among authors/reviewers as appropriate (including problem-solving and resolution of issues). (15%) * Keep abreast of project status, clinical operating plans and ongoing/new studies, as well as scientific literature within the assigned project area. Maintain/develop current knowledge of regulatory guidelines, technological advances and industry standards. (15%) More... | |||
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