Medical Writer

About Celerion

Celerion is dedicated to advancing clinical research with speed and excellence through translational medicine, employing experience, agility, and innovative strategies to accelerate drug market readiness.

Role Overview

We are seeking a full-time Medical Writer working remotely to analyze and interpret safety outcomes from clinical trials, draft and revise clinical study reports and related industry documents, and ensure accurate classification of events and medications using standard coding systems.

Key Responsibilities

• Interpret a range of medical results such as vital signs, lab values, adverse events, ECGs, diagnostic tests, and pharmacodynamic endpoints.
• Draft clinical documents for Phase I and II trials, including clinical study reports, safety narratives, and summarized reports.
• Assess whether safety goals and endpoints have been achieved and convey findings accurately within safety text.
• Perform peer quality control of safety text before CSR inclusion and review reports for completeness and accuracy, suggesting modifications or rewriting when needed.
• Serve as the Report Lead for scientific project teams to ensure high-quality and timely report delivery.
• Monitor editorial feedback to ensure the accuracy of incorporated report comments supporting safety objectives.
• Ensure all deliverables meet regulatory standards like Good Clinical Practice and ICH guidelines as well as client requirements.
• Utilize technology platforms to collaborate with international teams, including WebEx™, Veeva, Microsoft® 365, SharePoint®, and SmartSheet.
• Lead client communications related to projects.
• Coordinate with internal departments such as data management, project management, and business development.
• Participate in activities that enhance the success of the department and/or market segment team.

Qualifications and Skills

• Bachelor's degree or professional license in a medical or scientific field (RN, BS, RPh, MS, MPH) or equivalent experience.
• 1 to 3 years of experience in hospital or clinical settings or interpreting medical/clinical data.
• Strong writing and editing skills for clear and precise clinical trial report documentation.
• Detail-focused, thorough, and systematic approach.
• Ability to work independently and manage pressure effectively.
• Capacity to handle multiple tasks and rapidly adapt to shifting priorities and deadlines.
• Excellent communication and interpersonal abilities.
• Preferred knowledge of medical, pharmaceutical, or clinical research concepts.

Company Values and Inclusion

Celerion fosters a culture of integrity, trust, teamwork, and respect. We are an equal opportunity employer, welcoming candidates regardless of race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, veteran status, or disability.

Additional Notes

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Artificial intelligence tools may be used to support application review and assessment processes, assisting the recruitment team without replacing human decision-making. Final hiring decisions rest with human evaluators. Inquiries about data processing may be directed to our contact channels.