Senior Medical Writer - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Parexel is looking for a Senior Medical Writer located anywhere in the United States or Canada.Early Development/Translational Medical Writing experience required. Job Purpose:The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals.Key Accountabilities:LeadershipLeads cross-functional teams to draft agreed-upon scientific/medical content that addresses data interpretation, product claims, and internal/external questions • Coordinates and delivers document kick-off meetings with contributors or representatives from cross-functional groups • Coordinates activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines • Ensures communication between members remains open and information is disseminated appropriately • Possible participation in the orientation and coaching of junior team membersRegulatory Document AuthoringDevelops, coordinates, and oversees work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines • Develops and maintains timelines in project plans, using project tracking application following standard templatesWith minimal guidance from senior members of writing staff, prepares clinical study reports (CSRs), protocols, investigator brochures (IBs), submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development • Manages messaging for consistency with historical information and in alignment with agreed-upon strategyApplies lean authoring principles as part of document development and, when applicable, structured content management (SCM) text libraries as part of authoring processEnsures adherence to standard content, lean authoring, and messaging across team members • Works as an active member of cross-functional teams representing Medical Writing • Conducts appropriate literature searches, as needed Compliance with Parexel StandardsComplies with required training curriculum • Completes timesheets accurately as required • Submits expense reports as required• Updates CV as requiredMaintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills:Focused writing and editing following defined processes and templates • Expert level authoring in MS Word, understanding of MS Word functionality, and works with Word add-ins that facilitate the management of fonts, styles, references, etc • Follows directions, templates, and structured processes for delivering documents for review and finalizationParticipates in Medical Writing department initiatives, as appropriate. • Researches regulatory requirements to remain current in the regulatory landscape • Shares lessons learned and best practices • Ability to work independently • Ability to move across therapeutic areas to support business continuity and resource needs • Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion • Customer focused with communication skills commensurate with a professional working environment as well as effective time management, organizational, and interpersonal skills • Fluent in reading and writing American English Knowledge and Experience:Minimum 5 years in writing regulatory documents supporting global filings • Oncology and/or Infectious Disease/Vaccines experience • Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the EU and USRegulatory filing experience with a focus in authoring a broad set of different clinical document types that support regulatory filings such as protocols, amendments, CSRs, and common technical document summary documents with a preference for experience with Module 2.7, 5.2, CSRs, protocols, amendments, and IBs • Understanding of clinical development process from program planning to submission, including clinical trial design as well as medical practices regarding procedures, medications, and treatment for different disease states • Ability to facilitate review meeting