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

Sr. Associate, Basic Results Author

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