Senior Medical Writer

Senior Medical WriterSynterex, Inc. is a global consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.Synterex is seeking an organized, motivated, and collaborative individual for our medical writing team. The senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents. The medical writer may produce protocols, publications, study reports, investigator brochures, narratives, and module documents, according to client and agency guidelines, to support drug development under brisk timelines.Location: Fully remote, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients as requested.Essential Duties & ResponsibilitiesLead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelinesCoordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensure timely completion of documentsEnsure document development adheres to any relevant client processes, templates, and instructional documentsServe as an expert on client document management system and related tools, templates, and procedures to ensure efficient document developmentLead document message development in collaboration with clientInterpret data and create shell documents to support authoringPlan and lead kickoff meetingsFacilitate resolution of review feedback including planning and leading comment resolution meetings (curate review comments to ensure meetings are efficient)Follow-up with individual team members as needed to resolve outstanding review feedbackEnsure consistency among client programs in terms of messaging, formatting, and presentation of documentsConduct literature searches as neededPerform peer QC review as neededContribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if neededRequirementsExperience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical fieldBachelor's degree or higher in a relevant fieldOncology, Infectious Disease, or Vaccine experience desiredExperience desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documentsFlexibility to work across multiple therapeutic areas, if neededExperience writing documents according to established processes and document templatesFamiliarity with lean authoring approaches and structured content managementFamiliarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desiredExpertise with Microsoft Word and other Microsoft applicationsExperience developing documents using document management systems, collaborative authoring tools, and review toolsComfortable adapting to new tools and technologies, if neededAbility to work both independently and collaboratively in the face of competing prioritiesService-oriented and proactive approach to project managementExcellent conflict management and negotiation skillsComfortable providing suggestions based on previous experienceStrong written and verbal communication skillsFor further information or to apply, please reach out to View email address on click.appcast.io provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Synterex participates in the Department of Defense's SkillBridge program. For more information, please visit