Job highlights

- B Pharm / M Pharm / Pharm D / MBBS. . 2-3 years of relevant experience. . Specialisation in Pharmacy Practice,Clinical Pharmacy,Pharmacology,or related discipline. . Hands-on knowledge of CTD modules and submission procedures for FDA,EMA,and CDSCO. . Strong understanding of drug development,trial designs,endpoints,and ICH-GCP guidelines.

- Qualifications &
- Experience

Job Summary

The Senior Executive - Clinical Development provides scientific, medical-writing, and regulatory-documentation support for clinical development programmes (including New Chemical Entities / NCEs) across India, the US, and the EU.

This is an execution and coordination role reporting to the Clinical Development Lead; strategic approvals and final medical judgments remain with authorized functional leaders.

Key Responsibilities

- Medical Writing &
- Evidence:

Conduct structured searches (PubMed, ClinicalTrials.gov), build evidence tables, and draft manuscripts, abstracts, FAQs, and training content.

- Clinical Documentation: Draft/review clinical plans, protocols, Investigator Brochures (IB), study manuals, protocol amendments, and ethics committee query responses.

- Regulatory Support: Compile CTD/eCTD Module 2 (2.5 & 2.7) and Module 5 content. Prepare briefing books for US FDA (pre-IND), EMA (Scientific Advice), and CDSCO. Track submission timelines.

- Quality &

- Compliance:

Maintain absolute data integrity, version control,



and source traceability. Ensure strict ICH-GCP compliance and audit readiness.

- Cross-Functional Coordination: Coordinate deliverables across Clinical Operations, Reg Affairs, PV, Biostatistics, and external CROs. Manage project trackers and agendas.

Qualifications &

- Experience

- B. Pharm / M. Pharm / Pharm. D / MBBS.

- 2-3 years of relevant experience.

- Specialisation in Pharmacy Practice, Clinical Pharmacy, Pharmacology, or related discipline.

- Hands-on knowledge of CTD modules and submission procedures for FDA, EMA, and CDSCO.

- Strong understanding of drug development, trial designs, endpoints, and ICH-GCP guidelines.

- High-level literature search, critical data appraisal, referencing, and document QC skills.

- Proficient in MS Office; reference-management tools are a plus.

- Medical writing or global submissions experience in pharma/biotech is preferred.

- Exposure to NCEs, MASH/metabolic, ophthalmology, or pediatrics is advantageous.

Job Details

- Location: Bengaluru

- Employment Type: Full time, Permanent

- Experience: 2-3 years

- Department: Clinical Development

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr Executive - Clinical Development (Bengaluru)
🏢 Bioplus Life Sciences
📍 Bengaluru