Are you a skilled Medical Writer with 4-8 years of experience in the pharmaceutical and life sciences industry? Sun Pharma, a leading global pharmaceutical company, is hiring for the role of Medical Writer. This is a full-time, permanent position offering a remote work opportunity with the hiring office located in Gurugram. With less than 10 applicants so far, this is your chance to join a reputed organization and advance your career in medical writing.
About Sun Pharma
Sun Pharma is one of the largest pharmaceutical companies globally, known for its commitment to quality, innovation, and patient care. With over 4.05789 reviews from employees, the company has established itself as a trusted name in the industry. Sun Pharma offers a dynamic work environment, opportunities for professional growth, and a chance to contribute to meaningful projects that impact global healthcare.
Job Details
- Role: Medical Writer
- Industry Type: Pharmaceutical & Life Sciences
- Department: Research & Development (R&D)
- Experience: 4-8 Years
- Location: Remote (Hiring office in Gurugram)
Key Responsibilities
As a Medical Writer at Sun Pharma, you will play a crucial role in supporting the R&D and business teams by preparing high-quality medical documents. Your responsibilities will include:
- Preparation of Medical Writing Documents:
- Create and update documents for fresh and renewal filings within defined timelines.
- Develop labels, prescribing information, Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and Medication Guides.
- Prepare Expert Reports, including Clinical and Nonclinical Expert Reports, and Medical Data Packages.
- Draft Annual Reports for US NDA submissions.
- Support for Drug Product Lifecycle & 505b2 Projects:
- Provide medical rationales, therapeutic justifications, and bio-recommendations.
- Prepare bio-waivers, bio-reports, and other medical write-ups.
- Assist in the development of Pre-IND/IND/NDA documents, Initial Paediatric Study Plans, and labels.
- Quality Assurance & Compliance:
- Ensure all documents comply with SOPs and regulatory guidelines.
- Maintain zero critical errors in documents as per quality metrics (QM).
- Training & Development:
- Attend and conduct training sessions for the team to enhance skills and knowledge.
Skills and Qualifications
- A strong background in medical writing with 4-8 years of experience in the pharmaceutical industry.
- In-depth knowledge of regulatory guidelines and documentation requirements.
- Excellent written and verbal communication skills.
- Ability to work independently and meet tight deadlines.
- Attention to detail and a commitment to quality.
