Exciting opportunity for Pharma candidates to pursue their career in Clinical Research at Sami-Sabinsa Group

Founded by Dr. Muhammed Majeed in 1991, an internationally acclaimed scientist and entrepreneur in the area of "Evidence Based Medicine”, Sami-Sabinsa Group is a research-oriented multinational health science company and a leading producer of nutraceuticals, cosmeceuticals, standardized herbal extracts, fine chemicals, specialty chemicals, and probiotics. The Government of India honored Sami-Sabinsa Group with the National Award for Quality Products (Basic Drugs) in the year 1994 and the Prestigious DSIR award in the year 2002.

Post : Executive - Clinical Research

Exciting opportunity for candidates who are interested to pursue their career as Executive - Clinical Research in Nutraceutical Industry.

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 clear 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 copy editing 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 & Important) : Drafting manuscripts for peer-reviewed journals, abstracts, and presentations to disseminate trial findings to the broader scientific community.

Additional Information
Location : Peenya, Bengaluru (Karnataka)
Experience : 3-5 years
Qualification : M. Pharma (Pharmacy Practice) / Pharm.D
Job Type : Permanent