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IQVIA, a global leader in clinical research and healthcare intelligence, is hiring a Medical Writer 1 for its Gurugram location. This opportunity is ideal for professionals with 1โ3 years of experience in clinical medical writing, looking to work on global clinical research projects while adhering to international regulatory standards such as GCP.
This role involves acting as a Lead Medical Writer on straightforward projects, preparing clinical documents like clinical study reports (CSRs) and protocols, and collaborating with cross-functional project teams and global clients.
๐งช Key Responsibilities โ Medical Writer 1 (IQVIA)
- Act as Lead Medical Writer for simpler clinical documents under standard timelines
- Prepare clinical and regulatory documents in line with IQVIA SOPs and client requirements
- Confirm scope, templates, document specifications, and negotiate timelines
- Manage day-to-day project workload, tracking timelines and deliverables
- Communicate directly with customers and participate in comment resolution meetings
- Attend and contribute to project team and kick-off meetings
- Assist in monitoring and forecasting budgeted hours and out-of-scope activities
- Stay updated with developments in drug development, medical writing, GCP, and regulatory guidelines
๐ Qualifications & Experience Required
Mandatory:
- Bachelorโs degree in Life Sciences, Pharmacy, Biotechnology, or related field
- 1โ3 years of relevant experience in clinical or regulatory medical writing
- Strong familiarity with clinical study reports, protocols, and related documents
- Good understanding of statistical methods used in clinical trials
- Excellent written and verbal communication skills
- Strong attention to detail and ability to manage multiple projects
Preferred:
- Masterโs degree or PhD in Life Sciences or related discipline
- Ability to review Statistical Analysis Plans (SAPs) and identify inconsistencies
- Experience interpreting and summarizing clinical data from multiple sources
๐ผ Skills & Competencies
- In-depth knowledge of drug development and medical writing regulations
- Understanding of medical terminology across therapeutic areas
- Strong collaboration and independent decision-making skills
- Professional judgment in seeking senior input when required
- Proficiency in standard computer and documentation tools
๐ฐ Salary & Benefits (Estimated)
- Salary Range: โน6,00,000 โ โน9,00,000 per annum (INR, industry-aligned estimate)
- Competitive compensation package
- Exposure to global clinical research projects
- Career growth within a leading CRO
- Collaborative and compliance-driven work culture
๐ How to Apply
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