Associate Medical Writer
Job description
Employer Industry: Contract Research Organization
Why Consider this Job Opportunity:
- Opportunity for career advancement and growth within the organization
- Competitive pay with bonuses offered
- Comprehensive benefits package
- Chance to work in a stable yet innovative environment
- Collaborative and supportive work culture
- Emphasis on delivering quality and on-time services
What to Expect (Job Responsibilities):
- Write, edit, and review Essential Documents for clinical projects
- Collect and track documents for Clinical Study Report (CSR) appendices
- Critically assess and summarize data from clinical studies
- Review scientific literature relevant to medical writing activities
- Perform quality control reviews of Essential Documents
What is Required (Qualifications):
- Bachelor's/Master's degree in biomedical or life sciences fields
- Minimum 2 years of industry experience in clinical documentation
- Previous experience in pharmaceutical, biotechnology, or contract research organization
- Knowledge of global regulations and guidelines (FDA, ICH) on drug development
- Familiarity with electronic Common Technical Document (eCTD) requirements
How to Stand Out (Preferred Qualifications):
- Experience working with patient safety narratives
- Strong communication and organizational skills