Senior Strategic Medical Writer
United StatesFull-TimeSenior
SalaryUSD 96500 - 183500 / year
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Job Details
- Experience
- 4+ years
- Required Skills
- GCP
Requirements
- 4+ years of bio-pharmaceutical industry experience in global pharma, biotech, or life sciences.
- Bachelor's Degree or higher (scientific discipline preferred).
- Comprehensive knowledge of medical and scientific terminology.
- Experience writing and editing clinical/regulatory documents following ICH and GCP guidelines.
- Familiarity with industry standards like CONSORT and PRISMA.
- Understanding of drug development, clinical research, study designs, biostatistics, and pharmacology.
- Ability to analyze complex data sets.
- Strong organizational, time management, and problem-solving skills.
- Ability to manage multiple projects and cross-functional collaborations simultaneously.
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day) is required.
Responsibilities
- Prepare clinical and regulatory documents required for drug and device development.
- Develop and apply understanding of submission strategies with moderate autonomy.
- Coordinate review, approval, and quality control processes for clinical and regulatory projects.
- Manage documentation quality and compliance to ensure delivery within project timelines.
- Collaborate with R&D Quality Assurance to address inquiries and draft responses for inspections.
- Identify and resolve issues during the writing process, escalating when necessary.
- Execute tactical process improvements.
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