Senior Medical Writer
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Job Description
Lead Medical Writer at IQVIA developing and reviewing clinical documents. Collaborating with teams and providing mentorship while ensuring compliance with SOPs and customer requirements.
Responsibilities:
- Acts as Lead Medical Writer on writing projects
- Prepares documents in accordance with SOPs and customer requirements
- Performs Senior Review of straightforward deliverables
- Negotiates timelines and resolves customer comments
- Provides feedback to junior staff and customers
- Keeps abreast of current regulatory knowledge and guidelines
Requirements:
- Bachelor's Degree in life sciences related discipline or related field required
- Master's Degree in life sciences related discipline or related field preferred
- Ph.D. in life sciences related discipline or related field preferred
- Typically requires at least 5 years of highly relevant experience
- In-depth knowledge of clinical study reports and protocols
- Good understanding of statistical methods used in clinical trials
- Ability to integrate, interpret, and summarize data from various sources
- Significant experience as a lead writer in preparing clinical study reports and protocols
- Knowledge of drug development and associated regulations
- Excellent written and oral communication skills
- Good understanding of medical terminology across various therapeutic areas.
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
- Bonuses
- Wellness programs
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