DEPUTY MANAGER

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Date: Mar 12, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

The Specialist – Medical Writing in Clinical Development is responsible for the preparation of high-quality, scientifically sound clinical and regulatory documents. This role plays a pivotal part in communicating complex clinical data in a clear, concise, and compliant manner for regulatory agencies, healthcare professionals, and internal stakeholders. The specialist collaborates closely with clinical, regulatory, statistical, and medical teams to support clinical development programs from protocol design through to regulatory submissions.

Academic Stream

PHARMACEUTICAL SCIENCES

Work experience (in months)

24

Job Responsibility and key Decisions

Document Development Write, review, and finalize highquality clinical and regulatory documents across different phases of development Phase IIV in compliance with internal and external requirements.

Data Analysis Support Collaborate with biostatistics and data management teams to ensure accurate interpretation and integration of clinical data into documents.

Project Coordination Plan and manage timelines for assigned writing projects, coordinating inputs from subject matter experts and ensuring adherence to submission schedules.

Quality Control Perform rigorous quality checks and document reviews to ensure factual accuracy, consistency, formatting compliance, and adherence to regulatory and editorial standards.

Stakeholder Communication Liaise with clinical leads, regulatory affairs, pharmacovigilance, and external partners to gather input, resolve queries, and align on messaging.

Regulatory Submission Support Contribute to the preparation of submission dossiers e.g., IND, NDA, MAA, briefing documents for regulatory meetings, and responses to health authority queries.

Audit Readiness Maintain auditcompliant documentation practices and support inspection readiness activities by ensuring traceability, version control, and documentation of key decisions.

Process Improvement Identify opportunities to streamline document development processes and contribute to the evolution of templates, standards, and SOPs.

Training and Mentoring As needed, support the onboarding and development of junior medical writers by sharing best practices, conducting reviews, or offering feedback.