Senior Manager, Medical Writing
Based in the United StatesFull-TimeManager
Salary$132,000 – $172,000
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Job Details
- Experience
- 7+ years
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree in Life Sciences, Medical/Health Sciences, Technical Writing, or a related field required; advanced degree (MS, PharmD, PhD) preferred.
- 7+ years of experience in medical writing, regulatory writing, document management, or related roles within biotech, pharma, CRO, or healthcare environments.
- Proven experience authoring complex clinical and regulatory documents supporting drug development and regulatory submissions.
- Strong understanding of global drug development processes and regulatory requirements (FDA, EMA, ICH, and others).
- Demonstrated ability to independently manage complex writing projects, prioritize effectively, and meet tight deadlines.
- Exceptional scientific writing, editing, and communication skills with strong attention to detail and quality.
- Experience collaborating effectively with cross-functional stakeholders in a matrixed environment.
- Proficiency with Microsoft Office and familiarity with document management systems (e.g., Veeva or similar platforms).
- Strong interpersonal skills with the ability to communicate complex scientific content to both technical and non-technical audiences.
- Adaptability to shifting priorities and evolving project requirements in a fast-paced development environment.
Responsibilities
- Lead the authoring, review, and coordination of regulatory, clinical, and safety documents including protocols, protocol amendments, CSRs, IBs, CTD modules, briefing documents, and submission materials.
- Translate complex clinical, scientific, and regulatory data into clear, accurate, and submission-ready documents that meet global regulatory expectations.
- Manage end-to-end document development processes, including timelines, review cycles, and resolution of stakeholder comments to ensure on-time delivery.
- Partner closely with cross-functional teams to ensure consistency, scientific accuracy, and regulatory compliance across all written deliverables.
- Ensure adherence to applicable FDA, EMA, ICH, and other global regulatory guidelines and industry standards.
- Lead or contribute to the development and continuous improvement of medical writing processes, templates, style guides, and SOPs.
- Provide strategic medical writing expertise across clinical development and post-marketing activities, supporting regulatory strategy and submission readiness.
- Maintain deep therapeutic and product knowledge to support high-quality scientific communication and documentation.
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