Senior Executive – Clinical Development

Bioplus Life Sciences Pvt. Ltd.; Bengaluru; Sur place; INR 600 000 - 900 000; Plein temps

Résumé du poste

Bioplus Life Sciences Pvt. Ltd. is seeking a Clinical Development professional to support evidence generation, medical writing, regulatory documentation, and cross-functional coordination across India, US, and EU.

You will execute and coordinate under the Clinical Development Lead while strategic approvals remain with senior leaders. The role requires B.Pharm/M.Pharm/Pharm.D/MBBS with 2–3 years of relevant experience and CTD submission knowledge. Department: Clinical Development.

Qualifications

• Bachelors/Doctorate in pharmacy or related field.
• Experience in pharma/biotech regulatory submissions preferred.

Responsabilités

• Medical Writing & Evidence: conduct searches, build evidence tables, draft manuscripts, abstracts, FAQs, and training content.
• Clinical Documentation: draft/review clinical plans, protocols, IBs, study manuals, amendments, and ethics committee responses.
• Regulatory Support: compile CTD/eCTD content and briefing books for FDA/EMA/CDSCO; track submission timelines.
• Quality & Compliance: ensure ICH-GCP compliance, data integrity, version control and audit readiness.
• Cross-Functional Coordination: coordinate deliverables across Clinical Operations, Reg Affairs, PV, Biostatistics and CROs.

Connaissances

Medical writing

Literature search

Regulatory submissions

MS Office

Document QC

Formation

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

Outils

Reference-management tools

CTD modules knowledge

Description du poste

Support clinical development programmes through scientific evidence generation, medical writing, regulatory documentation, and cross-functional coordination 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.

Employment Type Full-Time, Permanent

Experience 2-3 years

Department Clinical Development

Posted Oct 2026