Position: Executive - Clinical Research.

We have an exciting chance for candidates who are interested to pursue their career as Executive - Clinical Research in Nutraceutical Industry.

Experience: 3-5yrs.

Education: M. Pharma (Pharmacy Practice) / Pharm D.

Job Location: Bangalore.

Job Type: Permanent.

Roles and Responsibilities:
Document Development: Authoring, compiling, writing, and editing key clinical documents such as clinical trial protocols (CTPs), protocol amendments, Investigator's Brochures IBs), and Clinical Study Reports (CSRs).
Regulatory Compliance: Ensuring all documents adhere to established regulatory standards and guidelines, including those from the ICH (e.g., ICH E3), FDA, and EMA.
Data Interpretation: Reviewing and interpreting complex clinical data, statistical analysis plans (SAPs), and results (e.g., tables, figures, listings) to create a transparent and accurate narrative.
Cross-functional Collaboration:



Working closely with multi-disciplinary teams, including biostatisticians, data managers, project managers, clinicians, and regulatory affairs specialists to gather necessary input and ensure consistency.
Quality Control (QC) & Editing: Performing quality control reviews and copyediting of documents to ensure scientific accuracy, clarity, consistency, and proper formatting according to guidelines.
Publishing & Submission Support: Compiling documents into the appropriate electronic format (e.g., eCTD submissions), including bookmarking and hyperlinking, for final submission to regulatory authorities.
Publication skills (Essential & significant) : Drafting manuscripts for peer-reviewed journals, abstracts, and presentations to disseminate trial findings to the broader scientific community.

📌 Medical Writer Bengaluru
🏢 Sami Sabinsa Group
📍 Bengaluru