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Ctt Team Member

2+ years
Not Disclosed
Pune, India
10 May 18, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Trial Transparency Specialist / Medical Writer

Company: Xogene

About Xogene

Xogene is transforming clinical trial transparency through AI-powered solutions. The company combines regulatory expertise with advanced technology to help pharmaceutical and life sciences organizations manage regulatory compliance efficiently. Their work focuses on automating complex clinical trial disclosure processes using AI and agentic networking capabilities.


Position Overview

The Clinical Trial Transparency Team at Xogene includes Analysts, Specialists, and Managers who provide expertise in:

  • Clinical trial protocol registration and results submission

  • Plain language medical writing

  • Redaction and anonymization of clinical and non-clinical documents

  • Clinical trial disclosure regulatory intelligence

  • AI development support through subject matter expertise

This role is ideal for self-motivated professionals with strong attention to detail, organizational skills, and medical writing experience who are interested in working at the intersection of healthcare compliance and AI innovation.


Key Responsibilities

Clinical Trial Disclosure Activities

  • Perform protocol registration and results posting for:

    • Drug clinical trials

    • Device clinical trials

    • Biologics clinical trials

Document Redaction & Anonymization

  • Redact and anonymize clinical and non-clinical documents

  • Remove:

    • Personally Identifiable Information (PII)

    • Company Confidential Information (CCI)

Medical Writing

  • Author plain language summaries of:

    • Clinical trial protocols

    • Clinical trial results

Quality Review

  • Review documents and content as part of quality control processes

Compliance & Project Coordination

  • Manage timelines and communicate with internal teams/stakeholders

  • Track disclosure activities and clinical trial compliance status

AI & Technology Collaboration

  • Support AI development initiatives by providing subject matter expertise in clinical trial transparency

Administrative Support

  • Maintain U.S. and international clinical trial registry/database postings

Process Improvement

  • Recommend and support continuous process improvements


Required Qualifications

Education

  • Bachelor’s degree in Health Sciences, Life Sciences, or a related field

  • Master’s degree preferred

Experience

  • Minimum 1 year of:

    • Medical writing experience, and/or

    • Medical data entry experience

Technical & Domain Knowledge

  • Understanding of:

    • Drug development

    • Clinical science

    • Clinical trial disclosure regulations

Skills

  • Strong organizational and time management skills

  • Excellent written and verbal communication

  • Analytical and detail-oriented mindset

  • Strong proficiency in:

    • Microsoft Word

    • Excel

    • PowerPoint

    • Adobe/PDF tools

Preferred Qualifications

  • Experience with:

    • ClinicalTrials.gov

    • EudraCT

Additional Requirements

  • Intercultural understanding with a global perspective

  • High attention to detail


What Xogene Offers

Professional Growth

  • Mentorship from industry experts

  • Professional development workshops and training

  • Clear career progression opportunities

Innovation & AI Exposure

  • Opportunities to contribute to AI advancements in clinical trial transparency

Work Culture

  • Results-oriented and innovation-driven environment

  • Flexible and meritocratic workplace culture

Compensation & Benefits

  • Competitive compensation package

  • Comprehensive employee benefits