Job Opportunity: Clinical Trial Transparency (CTT) Team Member – Pune

Job Summary:
Xogene is seeking a dedicated and detail-oriented Clinical Trial Transparency (CTT) Team Member to join our team in Pune. This hybrid position is ideal for professionals with a background in medical writing, clinical research, and regulatory compliance who are eager to work at the intersection of Artificial Intelligence (AI) and clinical trial disclosure. In this role, you will contribute to critical global regulatory transparency initiatives, ensuring that clinical data is managed with the highest standards of accuracy and compliance.

About the Role

Xogene is a leader in leveraging AI-powered solutions to streamline clinical trial transparency. As a CTT Team Member, you will play a vital role in navigating the complexities of global regulatory requirements. This position offers a high-growth environment for individuals looking to advance their careers in clinical research, regulatory affairs, and professional medical writing. You will work alongside industry experts to refine workflows and support the integration of advanced technology into healthcare transparency.

Key Responsibilities

As a member of the CTT team, your primary responsibilities will include:

• Clinical Trial Registration: Manage the protocol registration and results posting processes for drugs, biologics, and medical devices.
• Document Anonymization: Perform technical redaction and anonymization of clinical trial documents to ensure the removal of Protected Health Information (PII) and Commercially Confidential Information (CCI).
• Medical Writing: Author and update plain language summaries (PLS) for clinical trial protocols and study results, ensuring accessibility for diverse audiences.
• Quality Assurance: Conduct rigorous quality checks and document reviews to ensure full compliance with global regulatory standards.
• Submission Management: Maintain and update submissions for ClinicalTrials.gov and other global registries, while strictly tracking and meeting critical disclosure timelines.
• Stakeholder Collaboration: Partner with cross-functional teams to ensure consistent regulatory reporting and compliance.
• Innovation: Serve as a Subject Matter Expert (SME) to support AI development initiatives and contribute to process improvements in clinical transparency workflows.

Qualifications & Requirements

To be successful in this role, candidates must possess:

• Education: A Bachelor’s degree in Life Sciences or Health Sciences (a Master’s degree is preferred).
• Experience: A minimum of 1 year of professional experience in medical writing or clinical data management.
• Regulatory Knowledge: A solid understanding of the drug development lifecycle and clinical research processes, including familiarity with clinical trial disclosure regulations.
• Technical Proficiency: Strong skills in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat.
• System Knowledge: Prior experience with ClinicalTrials.gov or EudraCT systems is highly preferred.
• Soft Skills: Excellent communication, analytical, and organizational skills. You must be able to maintain high attention to detail while working effectively in a global, collaborative team environment.

Benefits

Joining Xogene means becoming part of a forward-thinking organization. We offer:

• Innovative Work: Opportunities to work on cutting-edge, AI-driven clinical transparency solutions.
• Professional Development: Mentorship from industry experts in the regulatory and clinical fields, with a clear path for career progression.
• Global Exposure: Deep insights into global regulatory frameworks and disclosure systems.
• Competitive Compensation: An attractive salary and comprehensive benefits package.
• Flexibility: A flexible hybrid work model based in our Pune office.
• Impact: The opportunity to contribute meaningfully to the future of AI-powered healthcare solutions.

How to Apply

If you are a motivated professional looking to advance your career in clinical trial transparency, we would love to hear from you. Please submit your application and updated resume through our official recruitment portal:

Click Here to Apply for the CTT Team Member Position