Medical Writer

Posted Sep 29

Celerion is committed to swift, exceptional clinical research through translational medicine.  Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.  

We are searching for a full-time Medical Writer to work remotely. This position will analyze and interpret safety results of clinical trials. Compile, write and edit clinical study reports and other industry documents. Confirm accurate classification of events and medications using standardized coding systems.

Responsibilities

  • Analyze and interpret all types of medical results including, but not limited to the following: vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and various pharmacodynamic (PD) endpoints.Compile and write Phase I and Phase II clinical trial documents including, but not limited to the following: clinical study reports (CSRs), stand-alone safety narratives, and synoptic CSRs.
  • Review/evaluate study results to determine whether or not the safety objectives and/or endpoints were met, accurately reflecting the results in the safety text. 
  •  Perform peer QC function of safety text prior to inclusion in the CSR.Review reports for completeness and accuracy assuring that the safety text fits into the CSR as whole and recommending changes or rewriting, as appropriate.
  • Monitor content of editorial comments received prior to incorporation into the report to assure report text comments are accurate and support the objectives and/or endpoints.
  • Assure deliverables are compliant with applicable regulatory standards (i.e. Good Clinical Practice, International Conference on Harmonisation guidelines) and client specifications.
  •  Proactively communicate with other members of the multi-disciplinary team to ensure medical writing quality and on-time delivery of the report.
  •  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).
  • Use technology to work with international teams (e.g., WebEx™, Microsoft® SharePoint®, and Microsoft® Office® applications).
  •  Interact with clients as needed.
  • Interact with internal departments (e.g. data management, project management, business development, etc.).
  •  Participate in functions required to ensure success of department and/or market segment team.

Requirements

  • Bachelor's degree and/or professional license in a medical or scientific field (RN, BS, RPh, MS, MPH) required or equivalent experience.
  • 1-3 years experience in hospital/clinical setting or interpreting medical or clinical results.
  • Professional writing and editing skills for accurate and concise reporting of clinical trial results; ability to interpret and present data in preparing a coherently written document.
  • Detail-oriented, thorough, and methodical.
  • Ability to work without close supervision and ability to work under pressure.
  • Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.
  • Excellent communication/ interpersonal skills.
  • Knowledge of medical, pharmaceutical, and/or clinical research concepts preferred. 

Celerion Values:      Integrity  Trust  Teamwork  Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.