North AmericaFull TimeHealthcare
Remotely
documentationregulatory compliancendaindmaaamwa
Job Description
📋 Description
- Lead the end-to-end development of assigned clinical and regulatory documents, from planning and
- Serve as the primary medical writing lead for assigned documents, which may include briefing books
- Partner with project management and cross-functional stakeholders to establish timelines
- Develop document strategies and content outlines with relevant subject-matter experts, assigning
- Translate complex scientific and clinical information into accurate, well-structured narratives
- Ensure documents comply with applicable US, ICH, and international regulations, guidelines
🎯 Requirements
- Master’s degree in a relevant scientific or related discipline; a PhD is preferred. Equivalent
- Approximately 5 years of progressively responsible experience in medical writing and scientific
- Exceptional scientific and medical writing skills, with demonstrated ability to transform complex
- Strong self-editing capabilities, with meticulous attention to readability, accuracy, consistency
- Solid knowledge of US, ICH, and international regulatory requirements and guidance governing
- Experience with Common Technical Document content and an understanding of documentation
🎁 Benefits
- Competitive base salary of $157,000–$196,500 USD, depending on experience, performance, and
- Eligibility for a discretionary annual bonus and equity awards.
- Competitive base compensation plus new-hire and ongoing equity opportunities.
- Medical, dental, and vision insurance.
- Employer-paid life insurance, disability coverage, business travel insurance, and Employee
- 401(k) plan with a fully vested 1:1 employer match up to 5%.
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