CTT Team Member – Clinical Trials Transparency
Location: Pune, Maharashtra, India (Hybrid)
Employment Type: Full-Time
Function: Clinical Trials Transparency
Industry: Life Sciences | Regulatory Compliance | AI-Enabled Solutions
About Xogene
Xogene is a global leader in clinical trial transparency services and technology, combining deep regulatory expertise with a modern, AI-powered technology stack. The company delivers end-to-end transparency platforms, regulatory disclosure services, and patient-focused trial websites that help sponsors meet global disclosure requirements efficiently and compliantly.
At Xogene, professionals work in a collaborative, high-impact environment that values innovation, accountability, and work-life balance. The organization is driven by a mission to advance transparency in clinical research while enabling meaningful career growth.
Role Overview
Xogene is seeking a CTT Team Member to join its Clinical Trials Transparency team in Pune. This role is ideal for experienced professionals with a background in medical writing, regulatory disclosure, or clinical research documentation who are passionate about global clinical trial compliance and AI-enabled regulatory solutions.
Key Responsibilities
Perform clinical trial registration and results posting activities for drug, biologic, and medical device studies in compliance with global regulatory requirements.
Conduct clinical and non-clinical document redaction to remove confidential, proprietary, and personal data.
Author Plain Language Summaries (PLS) in alignment with patient-centric and regulatory standards.
Review clinical trial documents and registry content as part of quality control and compliance checks.
Manage timelines and coordinate with internal teams and external stakeholders to ensure on-time regulatory submissions.
Track the status of active clinical trials and maintain accurate records of disclosure activities and compliance metrics.
Support administrative activities related to US and international clinical trial registry and results database postings.
Act as a primary point of contact for clinical trial transparency-related inquiries.
Required Qualifications & Experience
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline; Master’s degree preferred.
Experience:
3–5 years of professional experience in medical writing, clinical trial transparency, regulatory disclosure, or related clinical research roles.
Technical & Functional Skills:
Strong understanding of clinical trial disclosure regulations and transparency requirements.
Knowledge of drug development processes and clinical science.
Proficiency in Microsoft Office applications (Excel, Word, PowerPoint).
Soft Skills:
Excellent organizational and time management skills with a proactive, self-starter mindset.
High attention to detail and strong quality orientation.
Effective written and verbal communication skills.
Ability to work collaboratively within global, cross-functional teams.
Strong intercultural awareness and global perspective.
What Xogene Offers
Mentorship from industry experts working at the intersection of AI technology, regulatory science, and business strategy.
Clearly defined career progression pathways with increasing responsibility and leadership opportunities.
Exposure to cutting-edge AI technologies, including large language models (LLMs) and conversational systems.
Competitive compensation package with comprehensive benefits.
A results-driven, innovation-focused culture that values professional excellence, accountability, and collaboration.
Flexible hybrid work model supporting work-life balance.
Why Join Xogene?
At Xogene, your work directly contributes to improving clinical trial transparency, regulatory compliance, and patient trust worldwide. This role offers the opportunity to work on global programs, apply regulatory expertise at scale, and grow within a technology-forward organization shaping the future of clinical research transparency.
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