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Comw-0 Principal Medical Writer

10+ years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Full Time Education: BPharm/MPharm/PHD/BDS/BSC/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

### **Principal Medical Writer | Bangalore, India**  
**Job ID:** 282829 | **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 play a key role in **regulatory medical writing** for **marketed products and lifecycle management**. As a **Principal Medical Writer**, you will **lead, oversee, and coordinate** the preparation of **clinical and regulatory documents**, ensuring high-quality, compliant, and impactful medical communications.  

### **Who You Are**  
- **Education & Experience:**  
  - **Graduate/Postgraduate Degree** in **BPharm, MPharm, PhD, BDS, BSc, MSc, or related fields**.  
  - **10+ years of industry experience**, including **5-8 years in regulatory medical writing**.  
  - Expertise in **postmarketing studies** and **clinical documentation**.  
  - Strong command of **medical terminology and the AMA style guide**.  
  - **Excellent English writing and communication skills**.  

### **Your Responsibilities**  
- **Regulatory & Clinical Documentation**  
  - Independently prepare or oversee **clinical and regulatory documents**, including:  
    - **Protocols**  
    - **Clinical Study Reports (CSRs)**  
    - **Investigator Brochures**  
    - **Clinical Summary Documents**  
  - Support **submissions for market approvals and line extensions**.  
- **Leadership & Oversight**  
  - Coordinate and supervise **external writers** to ensure **content quality, consistency, and adherence to guidelines**.  
  - Represent **Medical Writing** in **clinical study teams**, leading document-related meetings.  
- **Compliance & Best Practices**  
  - Ensure documents comply with **regulatory requirements and company SOPs**.  
  - Contribute to **best practices, process improvements, and strategic initiatives** in Medical Writing.  

### **What We Offer**  
A dynamic and inclusive environment where **innovation, diversity, and career growth** drive success.  

🚀 **Apply now and be part of a global team shaping the future of medical writing!**