Lead and manage multiple medical writing programs by authoring/reviewing high-quality clinical and regulatory documents including submission documents of various types, e.g., study or program level. This is not a people management position, but the incumbent will oversee the work of medical writers. The incumbent will also provide direct input to project budgets, as needed, and drive the establishment of process, standards, and timely completion of high-quality deliverables. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the drug/program to ensure alignment and consistency across the projects. As the lead writer, the incumbent ensures timely completion, accuracy, and quality of all clinical and submission documentation across all aspects of the drug life cycle. The Director, Medical Writing will be the designated Lead Medical Writer for multiple programs, responsible for key document preparation and providing needed support and direction to other staff/contractors on these programs.
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