Senior Medical Writer
Celerion is the premier provider of innovative early clinical research solutions and is searching for a full-time Senior Medical Writer to interpret data and compile text for reports and other documents for Phase I and Phase II clinical trials. This position would be located in our Montreal, QC facility. Senior Medical Writer responsibilities are:
- Independently analyze and interpret all types of complex medical results from safety data listings, tables, and figures including vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and various pharmacodynamic (PD) endpoints.
- Independently compile and write complex Phase I and Phase II clinical trial documents for clinical study reports (CSRs), stand-alone safety narratives, integrated safety summaries, and synoptic CSRs, following the International Council for Harmonisation (ICH) Tripartite Guideline for Structure and Content of Clinical Study Reports (ICH E3).
- Review reports for completeness and accuracy assuring that the safety text fits into the CSR as a whole; recommending changes or rewriting, as appropriate, to assure the text addresses applicable study objectives and endpoints, and is of professional quality.
- Assure compliance with applicable regulatory standards (i.e. Good Clinical Practice, ICH guidelines) and client specifications.
- Monitor content of editorial comments received prior to incorporation into the CSR to assure report text is accurate and supports the study objectives and/or endpoints.
- Proactively communicate with other members of the multi-disciplinary team to ensure medical writing quality and on-time delivery of the CSR.
- Classify and confirm accurate classification of events and medications using standardized coding systems such as the World Health Organization Drug Dictionary (WHO DD), Medical Dictionary for Regulatory Activities (MedDRA®), and Common Terminology Criteria for Adverse Events (CTCAE).
- Train new employees in accordance with the Medical Writers Training Plan.
- Mentor less experienced medical writers and lead on complex projects, as necessary.
- Interact with internal and external clients pertaining to medical writing service capabilities and client satisfaction issues as required.