Manager, Medical Writing Operations

This is a fully remote position, open to applicants in California.

📋 Description

• Act as a subject matter expert for Microsoft Word, focusing on document formatting, style management, templates, and best practices in document production.

• Execute advanced document formatting and publishing tasks, which include managing complex tables, figures, references, cross-references, automated numbering, table of contents creation, and ensuring document quality control.

• Oversee the timelines for document development, review cycles, and activities related to comment resolution to guarantee the timely completion of high-quality deliverables.

• Create, maintain, and enhance standardized document templates, style guides, macros, and formatting tools to facilitate efficient document development and regulatory submissions.

• Collaborate with Medical Writing, Regulatory Operations, Clinical Development, Biometrics, Pharmacovigilance, and other departments to ensure documents are ready for submission and meet regulatory publishing standards.

• Write 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 documents related to submissions.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Medical/Health Sciences, Technical Writing, or a related field is required.

• Over 6 years of pertinent experience in medical writing, regulatory writing, document management, publishing, or medical writing operations within the biotechnology, pharmaceutical, CRO, or similar healthcare industry.

• Advanced skills in Microsoft Word, particularly in styles, templates, section management, automated numbering, cross-references, table of contents, document comparison tools, and large-document management.

• Experience in authoring and/or coordinating clinical and regulatory documents that support drug development programs and regulatory submissions.

• Familiarity with drug development processes and relevant global regulatory requirements.

🏝️ Benefits

• Premium health insurance.

• Financial benefits.

• Work-life balance initiatives.

• Well-being offerings for eligible employees and their dependents.

• Wellness and employee support programs.

• Life insurance coverage.

• Disability benefits.

• Retirement plans with employer matching contributions.

• Generous paid time off.