Medical Writer

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Create, edit, proofread, and finalize high-quality Expert Reports based on statistical results, study outcomes, and scientific conclusions.

• Collaborate with Statistical and Scientific teams to design and uphold Statistical Analysis Plans (SAPs) for cardiac safety studies.

• Ensure that all written outputs are scientifically precise, clearly articulated, and compliant with regulatory standards.

• Work with internal stakeholders to analyze study data and convey results effectively to sponsors.

• Oversee document timelines and priorities across various studies while upholding outstanding quality standards.

• Assist in the preparation of additional scientific and clinical study documentation as necessary.

• Contribute to enhancements and best practices in scientific and medical writing activities.

• Engage in client interactions and scientific discussions to facilitate successful project outcomes.

• Collaborate with Statistical and Scientific teams to aid sponsors in creating study synopses, protocols, and other clinical research documents pertinent to cardiac safety.

• Ensure the timely delivery of Expert Reports, Statistical Analysis Plans, and other significant study outputs.

• Maintain a thorough understanding of FDA, EMA, ICH, and other relevant regulatory guidelines concerning clinical trial reporting and documentation.

• Keep abreast of advancements in clinical research, cardiac safety assessment, and scientific communication.

• Support cross-functional initiatives within the broader Digital Physiology business.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Clinical Research, Pharmacy, Healthcare, or a related scientific field.

• Advanced degree (MSc, PhD, or PharmD) is preferred.

• At least 5 years of experience in medical, scientific, or clinical writing within the pharmaceutical, biotechnology, CRO, or clinical research industries.

• Experience in authoring scientific reports, statistical analysis plans, clinical study documentation, and regulatory submissions.

• Prior experience supporting Cardiology, Cardiac Safety, ECG analysis, electrophysiology, or cardiovascular clinical trials is required.

• Strong comprehension of clinical trials, ICH guidelines, and FDA and EMA regulatory requirements.

• Demonstrated ability to interpret and communicate complex clinical and statistical information.

• Excellent written communication skills, with a keen attention to detail and document quality standards.

• Strong organizational and project management abilities, capable of managing multiple priorities and deadlines.

• Experience collaborating with cross-functional teams, including statisticians, physicians, and scientific experts.

• Proficient in Microsoft Office applications, particularly Word.

• Ability to work independently and efficiently in a fast-paced global environment.

🏝️ Benefits

• Competitive salary and incentive programs.

• Private healthcare, pension, and life assurance.

• Flexible working arrangements that promote work-life balance.

• Generous annual leave and wellness initiatives.

• Opportunities for professional development within a global organization.

• Access to collaborative global teams and cutting-edge technologies.

• The chance to contribute to research that enhances patient outcomes worldwide.