Senior Strategic Medical Writer
A
AbbViePharmaceutical, Life Science
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 and regulatory documents following ICH guidelines and GCP.
- Familiarity with industry standards like CONSORT and PRISMA guidelines.
- Understanding of drug development, clinical research, study designs, biostatistics, and pharmacology.
- Ability to oversee multiple projects simultaneously.
- Strong organizational, time management, and problem-solving skills.
- Outstanding written and oral communication skills.
Responsibilities
- Prepare clinical and regulatory documents for drug and/or device development.
- Coordinate the review, approval, and quality control of clinical and regulatory projects.
- Arrange and conduct review meetings with cross-functional teams.
- Maintain document quality and compliance while meeting project timelines.
- Identify and propose solutions for issues arising during the writing process.
- Collaborate with leadership and R&D Quality Assurance to draft responses for regulatory inquiries.
- Participate in the execution of tactical process improvements.
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