This is an exciting leadership opportunity for a person with passion and talent. The company believes that medical writing is a science that continuously evolves with new regulations and technologies.  The role provides the ability to influence company leaders and work on exciting fast-paced drug development programs. This is your chance to join a dynamic Medical Writing team and be part of an emerging success story driven by the company’s unwavering commitment to patients and employees.The Role:The Medical Writing team is looking for an experienced, self-motivated individual knowledgeable of the current MW landscape to serve as Director, Medical Writing. The individual will be responsible for leading document strategy and development of complex clinical documents across programs/submissions.The position reports to the Senior Director, Global Medical Writing.What You’ll Do:Hands-on role focused on writing responsibilities, including acting as the Lead Medical Writer for complex studies/documents such as master protocols, investigator’s brochures, clinical study reports, and clinical summary documentsMentor junior medical writers as neededOverall responsibility for planning, implementing, and adhering to medical writing timelines for study/program needsRepresent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in NDA/MAA/IND submission planning and preparationStrong team player and a change agent who further reinforces/enhances Deciphera’s cultural valuesExcellent collaboration and people management skills with cross-functional partners and broader organization and outside agenciesLead/participate in significant workstreams that involve work across departments and with external vendors; may include participation in initiatives such as document templates, process development, automation of safety narratives, , and document reviewing/authoring toolsDeveloping and participating in department training and SOP developmentPerforming reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as neededMaintains cutting edge knowledge base of current developments in field and related technologiesRepresent Medical Writing in Inspection Readiness and participate in GCP Audits and Inspections
