Medical Writer (Cardiac Safety)

Location: United Kingdom Remote

Company

hirify.global, part of Thermo Fisher Scientific, provides Digital Physiology solutions that help pharmaceutical, biotechnology, and medical device companies generate evidence on the safety and effectiveness of new therapies.

What you will do

• Author, edit, proofread, and finalize Expert Reports based on statistical outputs, study findings, and scientific conclusions.
• Develop and maintain Statistical Analysis Plans for cardiac safety studies with statistical and scientific teams.
• Prepare study synopses, protocols, regulatory deliverables, and other clinical research documentation.
• Interpret complex clinical and statistical data and communicate results clearly to sponsors and internal stakeholders.
• Coordinate timelines and priorities across multiple studies while maintaining document quality and regulatory alignment.
• Support process improvements, client interactions, scientific discussions, and cross-functional initiatives within the Digital Physiology business.

Requirements

• Bachelor’s degree in Life Sciences, Clinical Research, Pharmacy, Healthcare, or a related scientific discipline; an MSc, PhD, or PharmD is preferred.
• At least 5 years of experience in medical, scientific, or clinical writing within pharmaceutical, biotechnology, CRO, or clinical research organizations.
• Experience authoring scientific reports, Statistical Analysis Plans, clinical study documentation, and regulatory deliverables.
• Previous experience with 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.
• Excellent written communication, attention to detail, organizational skills, and proficiency with Microsoft Office, particularly Word.

Culture & Benefits

• Flexible working arrangements supporting work-life balance.
• Private healthcare, pension, and life assurance.
• Generous annual leave and wellbeing initiatives.
• Professional growth opportunities within a global organization.
• Collaboration with global teams and access to innovative technologies.
• Work contributing to research and therapies that improve patient outcomes.