Sr Executive - Clinical Development

Bioplus Life Sciences Pvt. Ltd.; Bengaluru; Vor Ort; INR 900.000 - 1.300.000; Vollzeit

Zusammenfassung

Bioplus Life Sciences Pvt. Ltd. in Bengaluru is seeking a Senior Executive - Clinical Development to provide medical writing, regulatory documentation, and cross-functional coordination across India, the US, and the EU.

The role reports to the Clinical Development Lead and handles execution with strategic approvals reserved for senior leaders. The role focuses on preparing documents for CTD/eCTD submissions, ethics responses, and briefing books for regulatory authorities, while ensuring data

Qualifikationen

• 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.

Aufgaben

• Medical Writing & Evidence: Conduct structured searches, build evidence tables, and draft manuscripts, abstracts, FAQs, and training content.
• Clinical Documentation: Draft/review clinical plans, protocols, Investigator Brochures, study manuals, protocol amendments, and ethics committee query responses.
• Regulatory Support: Compile CTD/eCTD Module 2 and Module 5 content. Prepare briefing books for US FDA, EMA, and CDSCO. Track submission timelines.
• Quality & Compliance: Maintain absolute data integrity, version control, and source traceability. Ensure ICH-GCP compliance and audit readiness.
• Cross-Functional Coordination: Coordinate deliverables across Clinical Operations, Reg Affairs, PV, Biostatistics, and external CROs.

Kenntnisse

Medical Writing

CTD modules knowledge

FDA/EMA submissions

ICH-GCP knowledge

Literature search

MS Office

Ausbildung

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

Tools

Reference-management tools

Jobbeschreibung

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