Job 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 & Responsibilities Manage execution of documents, including creating, maintaining, and communicating timelines Coordinate 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 production Lead document message development in collaboration with client Plan and lead kickoff meetings and roundtable meetings for each document draft; curate review comments to ensure efficient roundtable meetings; plan and lead roundtable meetings Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents Perform peer QC review as needed Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management) Requirements Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field, or equivalent Bachelor’s degree in a relevant field Oncology experience Familiarity 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 desired Expertise with Microsoft Word and other Microsoft applications Familiarity with document management systems Ability to work both independently and collaboratively in the face of competing priorities Service-oriented and proactive approach to project management Excellent conflict management and negotiation skills Strong written and verbal communication skills For further information or to apply, please reach out to careers@synterex.com. #J-18808-Ljbffr Jobleads-US

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