We’re Hiring | Senior Executive – Clinical Development
📍 Location: Bengaluru, India
💼 Experience: 2–3 Years
🎓 Qualification: B. Pharm / M. Pharm / Pharm. D / MBBS
🏢 Department: Clinical Development
About the Role
Bioplus Life Sciences is looking for a scientifically driven professional to support clinical development programmes, including New Chemical Entities (NCEs), across India, the US, and Europe, with a focus on medical writing, clinical documentation, and regulatory submissions.
Key Responsibilities
Medical Writing: Conduct literature searches and draft manuscripts, abstracts, evidence tables, and training materials.
Clinical Documentation: Prepare and review clinical plans, protocols, Investigator’s Brochures, and study documentation.
Regulatory Support: Assist with CTD/eCTD Modules 2.5, 2.7, and 5, supporting US FDA, EMA, and CDSCO submissions.
Quality & Compliance: Ensure data integrity, document traceability, ICH-GCP compliance, and audit readiness.
Coordination: Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biostatistics, and external CROs.
Skills & Experience
Knowledge of clinical research, drug development, clinical trial designs, and ICH-GCP.
Understanding of regulatory documentation and submission procedures.
Strong medical writing, literature review, referencing, and document QC skills.
Proficiency in MS Office.
Experience in medical writing or global submissions is preferred. Exposure to NCEs, MASH/metabolic disorders, ophthalmology, or pediatrics is an advantage.
How to Apply
📧 Email: talent.acquisition@bioplus.in
🌐 Website: www.bioplus.in
Join us and contribute to advancing clinical development and scientific innovation!
