Senior Executive
Clinical Development

About the Role

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.