Medical Writer

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

📋 Description

• Analyze and interpret a variety of medical results, including but not limited to vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and various pharmacodynamic (PD) endpoints.

• Compile and draft clinical trial documents for Phase I and Phase II, encompassing but not limited to clinical study reports (CSRs), independent safety narratives, and synoptic CSRs.

• Review and assess study outcomes to determine if the safety objectives and/or endpoints were achieved, accurately representing the results in the safety narrative.

• Execute peer quality control of the safety text before it is included in the CSR.

• Examine reports for completeness and accuracy, ensuring the safety text integrates seamlessly into the CSR, while recommending revisions or rewrites as necessary.

• Act as the Project Report Lead within a multi-disciplinary scientific team, guaranteeing the quality and timely delivery of scientific reports.

• Oversee editorial comments received prior to their incorporation into the report to ensure that the report text comments are precise and support the objectives and/or endpoints.

• Ensure that deliverables are in compliance with relevant regulatory standards (i.e., Good Clinical Practice, International Conference on Harmonisation guidelines) and client specifications.

• Utilize technology to collaborate with international teams (e.g., WebEx™, Veeva, Microsoft® 365 applications, SharePoint®, and SmartSheet).

• Lead all project-related communication with clients.

• Collaborate with internal departments (e.g., data management, project management, business development, etc.).

• Engage in activities necessary to ensure the success of the department and/or market segment team.

⛳️ Requirements

• A Bachelor's degree and/or professional license in a medical or scientific field (RN, BS, RPh, MS, MPH) is required, or equivalent experience.

• 1-3 years of experience in a hospital or clinical environment, or in interpreting medical or clinical results.

• Strong professional writing and editing skills for accurate and succinct reporting of clinical trial results; capability to interpret and present data while preparing a coherent document.

• Detail-oriented, thorough, and methodical in approach.

• Ability to work independently without close supervision and under pressure.

• Capacity to multi-task and respond quickly to shifting priorities and tight timelines.

• Excellent communication and interpersonal skills.

• Familiarity with medical, pharmaceutical, and/or clinical research concepts is preferred.

🏝️ Benefits

• Celerion Values: Integrity, Trust, Teamwork, Respect