Senior Medical Writer - FSP

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: Leadership u2022 Leads cross-functional teams to draft agreed-upon scientific/medical content that addresses data interpretation, product claims, and internal/external questions u2022 Coordinates and delivers document kick-off meetings with contributors or representatives from cross-functional groups u2022 Coordinates activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines u2022 Ensures communication between members remains open and information is disseminated appropriately u2022 Possible participation in the orientation and coaching of junior team members Regulatory Document Authoring u2022 Develops, 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 u2022 Develops and maintains timelines in project plans, using project tracking application following standard templates u2022 With 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 u2022 Manages messaging for consistency with historical information and in alignment with agreed-upon strategy u2022 Applies lean authoring principles as part of document development and, when applicable, structured content management (SCM) text libraries as part of authoring process u2022 Ensures adherence to standard content, lean authoring, and messaging across team members u2022 Works as an active member of cross-functional teams representing Medical Writing u2022 Conducts appropriate literature searches, as needed Compliance with Parexel Standards u2022 Complies with required training curriculum u2022 Completes timesheets accurately as required u2022 Submits expense reports as required u2022 Updates CV as required u2022 Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: u2022 Focused writing and editing following defined processes and templates u2022 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 u2022 Follows directions, templates, and structured processes for delivering documents for review and finalization u2022 Participates in Medical Writing department initiatives, as appropriate. u2022 Researches regulatory requirements to remain current in the regulatory landscape u2022 Shares lessons learned and best practices u2022 Ability to work independently u2022 Ability to move across therapeutic areas to support business continuity and resource needs u2022 Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion u2022 Customer focused with communication skills commensurate with a professional working environment as well as effective time management, organizational, and interpersonal skills u2022 Fluent in reading and writing American English Knowledge and Experience: u2022 Minimum 5 years in writing regulatory documents supporting global filings u2022 Oncology and/or Infectious Disease/Vaccines experience u2022 Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the EU and US u2022 Regulatory 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 u2022 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 u2022 Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements u2022 Ability to interpret data and apply scientific knowledge to support regulatory document writing (i.e., IBs, protocols, amendments, CSRs, clinical summaries) as well as build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science u2022 Ability to develop and use story boards to drive statistical output planning, link data results to key messages, and develop templates as starting points for authoring u2022 Experience working on cross-functional teams with the ability to drive document content to support lean authoring u2022 Experience working in collaborative authoring tools and review tools, project tracking applications and document management systems; managing workflows eApproval/esignatures; and familiar with SCM and ability to author in an SCM environment using text libraries u2022 Flexibility in adapting to new tools and technology with capability of providing insight, alternatives, and suggestions based on previous experiences u2022 Capable of training writers/authors on the use of templates, guidelines, and tools Education: Bacheloru2019s degree or equivalent (Life Science preferred) #LI-LG4 #LI-REMOTEEEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Created: 2025-11-24