DDReg Pharma Pvt. Ltd. is a leading global consulting firm specializing in regulatory affairs, pharmacovigilance, and medical writing. With over a decade of experience, DDReg Pharma offers comprehensive services to pharmaceutical, biopharmaceutical, and medical device companies, ensuring compliance and accelerating market access. The company is headquartered in Gurgaon, Haryana, India, and operates internationally.
Job Overview
DDReg Pharma Pvt. Ltd. is seeking a detail-oriented and experienced Sr. Associate/Associate in Medical Writing to join their Drug Safety & Regulatory Affairs team. This full-time, on-site position in Gurgaon offers an excellent opportunity to contribute to global regulatory submissions and safety reporting.
Key Responsibilities
- Medical Writing: Prepare and review regulatory documents, including CTD modules, SmPCs, PIs, PILs, safety reports, and aggregate reports (PSUR/PBRER/PADER).
- Aggregate Reporting: Collect, analyze, and author aggregate reports; perform science review of reports produced by pharmacovigilance associates.
- Risk Management: Develop and author Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategies (REMS).
- Regulatory Compliance: Ensure all documents comply with client specifications, templates, and style guidelines.
- Safety Monitoring: Support the medical safety team in ongoing review and management of safety information.
- Training & Mentorship: Mentor associates on job skills, develop training materials, and conduct training sessions.
- Regulatory Intelligence: Conduct detailed searches on regulatory agency websites (e.g., US FDA, EMA, PMDA, TGA, UK MHRA) for safety alerts.
Qualifications
- Education: Master’s degree in Pharmacology, Pharmacy, Medicine, or a related field. Advanced degree preferred.
- Experience: Minimum of 3 years in medical writing within the pharmaceutical or CRO industry.
- Certifications: Additional qualifications in medical writing (e.g., AMWA, EMWA, RAC) are advantageous.
- Skills: Proficiency in regulatory writing, document formatting, and adherence to regulatory guidelines.
- Knowledge: Familiarity with global regulatory requirements and safety reporting standards.
Benefits
- Professional Development: Access to training programs and mentorship opportunities.
- Collaborative Environment: Work alongside experienced professionals in a dynamic team setting.
- Career Growth: Opportunities for advancement within the company.
- Competitive Compensation: Attractive salary package commensurate with experience.
How to Apply
