Sun Pharmaceutical Industries Ltd., one of the world’s largest specialty generics pharmaceutical companies, is seeking a talented Medical Writer for its R&D division in Gurgaon, India. This is an excellent opportunity for professionals passionate about scientific communication and regulatory documentation.

About Sun Pharmaceutical Industries Ltd.

With a legacy of innovation and excellence, Sun Pharma is a global leader in delivering high-quality, affordable medicines to patients worldwide. The company’s extensive portfolio spans generics, specialty, over-the-counter products, and active pharmaceutical ingredients. Its state-of-the-art R&D centers focus on creating impactful solutions that improve lives.

Job Responsibilities

As a Medical Writer, you will play a critical role in preparing high-quality, regulatory-compliant documents that drive product development and approvals. Key responsibilities include:

1. Document Preparation:
   • Drafting and reviewing medical documents for fresh and renewal filings, including:
     • Prescribing Information, Summary of Product Characteristics, Patient Information Leaflets, and Medication Guides.
     • Expert Reports (Clinical, Nonclinical) and Medical Data Packages.
     • Annual Reports for US NDAs.
   • Crafting responses to regulatory inquiries and preparing bio-waiver justifications and medical write-ups.
2. Support for R&D and Business:
   • Developing medical rationales, therapeutic justifications, and bio-recommendations.
   • Preparing Pre-IND, IND, NDA, Initial Pediatric Study Plans, and label documents.
3. Compliance and Quality:
   • Ensuring all documents adhere to SOPs, regulatory guidelines, and maintain zero critical errors.
   • Conducting and attending training sessions to enhance team capabilities.
4. New Product Evaluations:
   • Participating in new product proposals, evaluations, and providing medical support during development and filing phases.

Qualifications Required

To be eligible for this position, you must have:

• A Master’s degree in Pharmacy, Science, or a related field.
• Proven experience in medical writing, particularly with regulatory documentation for pharmaceutical products.
• Strong understanding of global regulatory guidelines (e.g., US FDA, EMA).

Key Skills

• Excellent writing, editing, and scientific communication abilities.
• In-depth knowledge of clinical and nonclinical data interpretation.
• Attention to detail and a commitment to quality and compliance.
• Strong organizational and time-management skills to meet tight deadlines.
• Collaborative mindset with the ability to work in cross-functional teams.

Application Link