Synterex, Inc.

Compensation

Full Description

Synterex, Inc. is a 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 medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in planning and preparation of high-quality clinical and 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 & ResponsibilitiesManage execution of documents, including creating, maintaining, and communicating timelinesCoordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing)Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document productionLead document message development in collaboration with clientPlan and lead kickoff meetings and roundtable meetings for each document draft; curate review comments to ensure efficient roundtable meetings; plan and lead roundtable meetingsEnsure consistency among client programs in terms of messaging, formatting, and presentation of documentsPerform peer QC review as neededContribute to medical writing operational initiatives (e.g., templates, style guides, reference management)RequirementsExperience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field, or equivalentBachelor’s degree in a relevant fieldOncology experienceFamiliarity 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 applicationsFamiliarity with document management systemsAbility to work both independently and collaboratively in the face of competing prioritiesService-oriented and proactive approach to project managementExcellent conflict management and negotiation skillsStrong written and verbal communication skillsFor further information or to apply, please reach out to careers@synterex.com. #J-18808-Ljbffr