Medical Writer
About this role
At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. Through our Digital Physiology solutions, we help pharmaceutical, biotechnology and medical device companies generate the data needed to assess the safety and effectiveness of new therapies.
As a Medical Writer within our Global Cardiac Solutions team, you will play a critical role in the communication of clinical trial results and scientific evidence. Working closely with statisticians, scientists and cardiac safety experts, you will develop high-quality expert reports, statistical analysis plans and other clinical study documentation that supports regulatory submissions and critical development decisions. This is an exciting opportunity for an experienced scientific writer who enjoys translating complex clinical and statistical data into clear, accurate and compelling scientific deliverables that contribute to the development of life-changing therapies.
What We Offer
Competitive compensation and incentive programmes
Private healthcare, pension and life assurance
Flexible working arrangements supporting work-life balance
Generous annual leave and wellbeing initiatives
Opportunities for professional growth within a global organisation
Access to collaborative global teams and innovative technologies
The opportunity to contribute to research that improves patient outcomes worldwide
What You'll Be Doing
Author, edit, proofread and finalise high-quality Expert Reports based on statistical outputs, study findings and scientific conclusions.
Partner with Statistical and Scientific teams to develop and maintain Statistical Analysis Plans (SAPs) for cardiac safety studies.
Ensure all written deliverables are scientifically accurate, clearly communicated and aligned with regulatory expectations.
Collaborate with internal stakeholders to interpret study data and effectively communicate results to sponsors.
Manage document timelines and priorities across multiple studies while maintaining exceptional quality standards.
Support the preparation of additional scientific and clinical study documentation as required.
Contribute to process improvements and best practices within scientific and medical writing activities.
Participate in client interactions and scientific discussions to support successful project delivery.
Partner with Statistical and Scientific teams to support sponsors in the development of study synopses, protocols and other clinical research documents related to cardiac safety.
Coordinate the timely delivery of Expert Reports, Statistical Analysis Plans and other key study outputs.
Maintain a strong understanding of FDA, EMA, ICH and other relevant regulatory guidance related to clinical trial reporting and documentation.
Stay current with developments in clinical research, cardiac safety assessment and scientific communication.
Support cross-functional initiatives within the broader Digital Physiology business.
What We Look For
Bachelor's degree in Life Sciences, Clinical Research, Pharmacy, Healthcare, or a related scientific discipline. Advanced degree (MSc, PhD or PharmD) preferred.
Minimum 5 years' experience in medical, scientific or clinical writing within the pharmaceutical, biotechnology, CRO or clinical research sectors.
Experience authoring scientific reports, statistical analysis plans, clinical study documentation and regulatory deliverables.
Previous experience supporting Cardiology, Cardiac Safety, ECG analysis, electrophysiology or cardiovascular clinical trials is required.
Strong understanding of clinical trials, ICH guidelines, and FDA and EMA regulatory requirements.
Proven ability to interpret and communicate complex clinical and statistical data.
Excellent written communication skills, attention to detail and document quality standards.
Strong organisational and project management skills, with the ability to manage multiple priorities and deadlines.
Experience collaborating with cross-functional teams, including statisticians, physicians and scientific experts.
Proficient in Microsoft Office applications, particularly Word.
Able to work independently and effectively within a fast-paced global environment.
At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It's a cause that unites and inspires us. It's why we come to work—and how we empower our people to make a positive impact every day.
Whether you're advancing clinical science, developing innovative technology, or supporting our customers around the world, your work helps bring life-changing therapies to patients faster.
Originally posted on Himalayas
