CTT Team Member

Why Xogene?

At Xogene, we believe work should be enjoyable, meaningful and promote work-life balance. Working with us means joining a vibrant community of like-minded individuals who are passionate about what they do. If you thrive in a fast-paced, innovative environment and want to be part of a global team that is shaping the future of clinical trial transparency services bolstered by our suite of modern and AI-powered technology products, we would love to hear from you. Make a difference and build a rewarding career with Xogene.

Position Overview

Offering a suite of services and software products, Xogene is a leader in innovative technologies and expert services to meet global clinical trial transparency. Combining deep transparency expertise with a modern technology stack, Xogene provides software solutions. We develop innovative, configurable solutions that include the first end-to-end transparency platforms to meet disclosure requirements and custom sponsor trial websites for patient engagement. 

The Roles: 
Xogene’s team of Analysts, Specialists, and Managers provide clinical trial transparency services which include authoring of protocol registrations and results postings for submission to local and global regulatory agencies, authoring plain language summaries, redaction of clinical and non-clinical documents, and clinical trials disclosure regulatory intelligence. 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. 

Responsibilities 

• Performing clinical trial posting activities for drug, device, and biologic clinical trials

• Performing clinical and non-clinical document redaction to remove confidential information

• Authoring plain language summaries

• 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

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

• Acting as point of contact for inquiries
  

• Bachelor Degree in a health or life science related discipline; Masters degree preferred

• 2+ 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

WHAT WE OFFER

·  Opportunities for growth and a clear career progression path with increasing responsibility as skills develop 

·   Mentorship from industry experts working at the intersection of AI technology and business strategy 

·   Exposure to cutting-edge AI technologies including LLMs and conversational systems 

·   Competitive compensation package including comprehensive benefits 

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