Associate Director, Regulatory Medical Writing

Details: Overview:POSITION SUMMARY:Provides technical and editorial expertise and administrative guidance to medical writers within the Worldwide Clinical Research Department with regard to regulatory document preparation processes, standards, quality, and timeliness in support of drug development, product registrations, and product marketing. The incumbent creates, revises, and maintains document templates; manages and oversees document quality control; coordinates clinical quality assurance workflow; and edits and critically reviews regulatory documents. Depending on the structure of the group, the role may be mainly focused on the operational aspects of document preparation or on document review, editing, and writing.Responsibilities:ESSENTIAL AREAS OF RESPONSIBILITYProvides technical expertise to writers in the use of document templates and other tools for the preparation of regulatory documents to ensure adherence to relevant standards and applicable regulations and guidelines.Provides editorial expertise to writers in the preparation of high“‘quality regulatory documents to ensure both high editorial quality and adherence with agreed writing standards.Provides administrative guidance to writers to ensure that standard processes and accepted practices are followed with regard to developing schedules and the overall preparation of documents.Develops and maintains document templates and guidance documentation.Works with writers and quality control (QC) staff to schedule document QC according to agreed time lines, and manages the QC workload.Works with writers and Clinical Quality Assurance (CQA) to schedule document audits according to agreed time lines.Performs macroediting of documents for organization, content, structure, and tone, and to ensure documents are consistent within clinical programs, and microediting of documents for punctuation, grammar, sentences, paragraphs, and writing styles.Critically reviews regulatory documents for content for comprehension and to ensure inclusion of clear and consistent messages.Represents Regulatory Medical Writing on interdepartmental projects and initiatives within Cephalon.10. Prepares regulatory documents as a senior contributor.

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