Manager, Medical Writing Operations

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🏄 California – Remote

🏄 California – Remote

💵 $116k - $151k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

✏️ Content Writer

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Travere Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Travere Therapeutics is a biopharmaceutical company committed to identifying, developing, and delivering life-changing therapies for people living with rare diseases, particularly those related to rare kidney and metabolic disorders. The company has a strong focus on advancing science in these fields, with a pipeline that includes treatments for conditions such as IgA nephropathy and focal segmental glomerulosclerosis. With the full U. S. FDA approval of its non-immunosuppressive treatment for IgA nephropathy, Travere Therapeutics continues to set new standards of care. The company collaborates with the rare kidney disease community, including patient advocacy organizations and clinical trial investigators, to bring hope to patients with these serious conditions.

📋 Description

• Serve as a subject matter expert for Microsoft Word, document formatting, style management, templates, and document production best practices • Perform advanced document formatting and publishing activities, including management of complex tables, figures, references, cross-references, automated numbering, table of contents generation, and document quality control • Manage document development timelines, review cycles, and comment resolution activities to ensure high-quality deliverables are completed on schedule • Develop, maintain, and improve standardized document templates, style guides, macros, and formatting tools to support efficient document development and regulatory submissions • Partner with Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance, and other functions to ensure documents are submission-ready and comply with regulatory publishing requirements • Author and coordinate the preparation of clinical, regulatory, and safety documents, including protocols, protocol amendments, clinical study reports (CSRs), investigator brochures (IBs), CTD components, and other submission-related documents.

🎯 Requirements

• Bachelor's degree in Life Sciences, Medical/Health Sciences, Technical Writing, or related field required • 6+ years of relevant experience in medical writing, regulatory writing, document management, publishing, or medical writing operations within the biotechnology, pharmaceutical, CRO, or related healthcare industry environment • Advanced proficiency in Microsoft Word, including styles, templates, section management, automated numbering, cross-references, tables of contents, document comparison tools, and large-document management • Experience authoring and/or coordinating clinical and regulatory documents supporting drug development programs and regulatory submissions. • Working knowledge of drug development processes and applicable global regulatory requirements.

🏖️ Benefits

• premium health • financial • work-life • well-being offerings for eligible employees and dependents • wellness and employee support programs • life insurance • disability • retirement plans with employer match • generous paid time off