CTT Team Member

Why Xogene?

At Xogene, we’re revolutionizing the future of clinical trial transparency through AI-powered solutions. Join our team of experts who are transforming how leading pharmaceutical and life sciences companies navigate regulatory compliance. If you're driven by solving complex problems in a professional environment focused on meaningful and rewarding work, we want to hear from you.

Position Overview

Xogene combines regulatory expertise with advanced technology to automate complex processes in clinical trial disclosure. As trusted experts with comprehensive knowledge of global regulatory frameworks, we deliver efficient data transformation and regulatory compliance for our clients, streamlining workflows through our AI and agentic networking capabilities. We're committed to leveraging technological solutions to advance clinical trial transparency.

About The Role:
Xogene’s Clinical Trial Transparency Team of Analysts, Specialists, and Managers provide clinical trial transparency expertise which include authoring of protocol registrations and results submission to local and global regulatory agencies, authoring plain language documents, redaction and anonymization of clinical and non-clinical documents, and clinical trials disclosure regulatory intelligence. This role may also involve direct collaboration with our technology team by offering subject matter expertise for AI development, ensuring that our core technology reflect the latest regulatory standards. As a fast growing, dynamic company, we are looking to grow our team with self-motivated, experienced medical writers and SMEs who are highly detail-oriented and organized with great communication skills. In return for the hard work and commitment to excellence from the team, Xogene offers a dynamic and meritocratic environment with great benefits and flexibility.

Key Task and Responsibilities:

• Performing clinical trial protocol registration and results posting activities for drug, device, and biologics clinical trials

• Performing clinical and non-clinical document redaction to remove and/or anonymize personal identifiable information (PII) and company confidential information (CCI)

• Authoring plain language summaries of clinical documents including protocol and results of clinical trials for disclosure

• Reviewing documents and content as part of a quality check process

• Managing timelines and communicating with internal team and/or stakeholders to ensure compliance

• Tracking status of all active clinical trials and recording clinical trial disclosure activities and compliance

• Supports artificial intelligence development for clinical trial transparency document writing as subject matter experts

• Supporting administrative aspects of maintaining US and international clinical trial registry and results database website postings

• Provides continuous process improvement suggestions

• Bachelor’s degree in a health or life science related discipline; Master’s degree preferred

• 1+ year(s) medical writing and/or medical data entry experience

• Demonstrated knowledge of drug development or clinical science

• Strong knowledge base of the evolving clinical trials disclosure regulatory environment

• Excellent organizational and time management skills

• Strong analytical skills and communication skills (both written and verbal)

• Strong computer skills with Microsoft Word, Excel, PowerPoint and Adobe (or any other PDF-related program)

• Experience with Clinicaltrials.gov and / or EudraCT is a plus (but not required)

• Attention to detail

• Intercultural understanding with a global perspective

• Knowledge of drug development or clinical science
  

WHAT WE OFFER

• Mentorship from industry experts working at the intersection of clinical trial transparency and AI technology

• Opportunities to shape AI advancements at Xogene, driving solutions that will set new industry standards

• Professional development workshops and training sessions, enhancing your skillset

• Clear career progression path with increasing responsibility as skills develop

• Competitive compensation package including comprehensive benefits

• A results-oriented culture that values innovation, responsibility, and professional excellence