Sun Pharmaceutical Industries Ltd, a global leader in pharmaceuticals, is seeking a highly skilled and experienced Medical Writer to join our Research & Development (R&D) team in Gurgaon. If you have a passion for medical writing, a strong understanding of regulatory guidelines, and at least 5+ years of experience, this is an excellent opportunity to contribute to cutting-edge pharmaceutical innovations.
Key Responsibilities of a Medical Writer
As a Medical Writer at Sun Pharma, you will play a critical role in ensuring the timely and accurate preparation of medical writing documents. Your responsibilities will include:
- Preparation of Medical Writing Documents:
- Create and update documents for fresh and renewal filings within strict timelines.
- Develop Labels such as Prescribing Information, Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and Medication Guides.
- Draft Expert Reports, including Clinical and Nonclinical Expert Reports, and Medical Data Packages.
- Prepare Annual Reports for US NDA filings.
- Write Medical Write-ups, Bio-waivers, and responses to Regulatory Information Requests (RFIs).
- Support for R&D and Business Projects:
- Provide medical writing support throughout the drug product life cycle and for 505b2 projects.
- Develop Medical Rationales and Therapeutic Justifications.
- Prepare Bio-recommendations, Bio-waivers, and Bio-reports.
- Assist in the preparation of Pre-IND/IND/NDA documents, Initial Paediatric Study Plans (iPSP), and Labels.
- Regulatory Compliance and Quality Standards:
- Ensure compliance with Standard Operating Procedures (SOPs) and regulatory guidelines.
- Maintain zero critical errors in documents as per Quality Metrics (QM).
- Conduct and attend training sessions to stay updated on industry standards and best practices.
- New Product Development:
- Evaluate and propose new product ideas to support the company’s growth and innovation goals.
Qualifications and Experience
- Minimum 5+ years of experience in medical writing within the pharmaceutical or biotechnology industry.
- Strong knowledge of regulatory guidelines (e.g., FDA, EMA, ICH).
- Proficiency in preparing clinical and nonclinical documents.
- Excellent written and verbal communication skills.
- Attention to detail and ability to work under tight deadlines.
Why Join Sun Pharmaceutical Industries Ltd?
- Be part of a globally recognized pharmaceutical leader.
- Work on innovative projects that impact patient lives worldwide.
- Collaborate with a team of industry experts in a dynamic R&D environment.
- Opportunities for professional growth and skill development.
