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Senior Specialist/Expert Medical Writer

4-9 years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Full Time Education: BPharm/MPharm/PHD,/BDSBSC/MSC/MD/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

### **Senior Specialist / Expert Medical Writer | Bangalore, India**  
**Job ID:** 282835 | **Location:** Bangalore, Karnataka | **Job Type:** Full-time  

#### **Work Your Magic with Us!**  
Join a **global leader in Healthcare, Life Science, and Electronics**, where you will contribute to **regulatory and clinical medical writing** for **marketed products and lifecycle management** at global and regional levels.  

### **About the Role**  
As a **Senior Specialist / Expert Medical Writer**, you will be responsible for preparing **clinical and regulatory documents**, supporting **market approval submissions**, and ensuring compliance with industry standards.  

### **Your Responsibilities**  
- **Regulatory & Clinical Documentation**  
  - Independently prepare **Protocols, Clinical Study Reports (CSRs), and Investigator Brochures**.  
  - Support **submissions for market approval and line extensions** under minimal supervision.  
  - Ensure adherence to **regulatory authority requirements and company SOPs**.  
- **Process Improvements & Compliance**  
  - Contribute to the **development and implementation of best practices** in medical writing.  
  - Oversee and coordinate **external medical writers** to ensure content clarity and consistency.  
  - Participate in **quality control (QC) and compliance activities**.  

### **Who You Are**  
#### **Minimum Qualifications**  
- **Graduate/Postgraduate degree** in **BPharm, MPharm, PhD, BDS, BSc/MSc**, or an equivalent field.  
- **4 to 9 years** of **regulatory medical writing experience**.  
- **Strong English writing and communication skills**, including medical terminology (AMA style guide preferred).  
- **Knowledge of clinical and regulatory documentation** processes.  

### **What We Offer**  
A **diverse, inclusive, and innovation-driven environment** that fosters **career growth and development**.  

🚀 **Apply now and be part of a global team driving scientific progress!**