Sr. Associate, Basic Results Author in Chennai, भारत

Senior Associate responsible for authoring and maintaining clinical trial results disclosures across global registries including https://jobeax.com/link/Fkrj4NBuHxs4K0JO and CTIS. The role transforms clinical study data into compliant results records while collaborating with cross-functional teams to ensure regulatory adherence and timely submission.

Responsibilities

• Author and prepare https://jobeax.com/link/Fkrj4NBuHxs4K0JO Basic Results records including participant flow, baseline characteristics, and outcome measures
• Review source documents such as protocols, statistical analysis plans, and clinical study reports to support results preparation
• Collaborate with clinical trial disclosure managers, clinicians, statisticians, and legal teams to resolve data questions and ensure accuracy
• Address quality review comments and support responses to regulatory reviewer feedback within disclosure timelines
• Maintain audit-ready documentation and ensure compliance with applicable regulatory requirements and internal procedures

Requirements

• Bachelor's or Master's degree in life sciences, pharmacy, biomedical sciences, or clinical research
• 3+ years basic results authoring, medical writing, or clinical trial disclosure experience with Bachelor's degree; or 1+ years with Master's degree
• Strong understanding of global disclosure regulations including FDAAA 801 and EU CTR 536/2014
• Project management and organizational skills with ability to manage complex priorities
• Excellent communication, analytical thinking, and attention to detail
• Ability to work cross-functionally across therapeutic areas and time zones
• Experience with Xogene Prime application preferred