Medical Writer I

2 weeks ago

Belfast, United Kingdom Celerion Full time

Medical Writer


Celerion is the premier provider of innovative early clinical research solutions and is searching for a full-time Medical Writer to analyze and interpret safety results of clinical trials and compile, write and edit clinical study reports and other industry documents.

This full-time position will be a hybrid role with both home and office based work in the UK.

  • 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), standalone 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 multidisciplinary team to ensure medical writing quality and ontime 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 international internal and external clients pertaining to medical writing service capabilities and client satisfaction issues as required.
An attractive salary and benefits package is available.

Celerion is an equal opportunity employer.

Requirements:

  • We require at least a bachelor's degree and/or professional license in a medical or scientific field (e.g., BSc, MSc, PhD, RN, RPh, MS, MPH);
  • 13 years medical writing experience in the pharmaceutical industry (e.g., pharmaceutical company or contract research organization).
  • We require expert knowledge of medical, pharmaceutical, and clinical research concepts, proven writing skills, ability to correlate PD and safety data to study drug pharmacology and physiological effects on body systems, and to interpret results in the context of the study.
  • Celerion is an Equal Opportunity Employer._

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