Medical Writer who specializes in clinical trials with imaging endpoints.
• Writes and revises study-specific documents including Independent Review Charters
(IRC), Site Imaging Manuals (SIM) and Independent Review Training Manuals
• Understands key reading criteria such as RECIST, mRECIST, Choi, RANO, Cheson,
Lugano Classification, Halleck, iRECIST, RECIL, iRANO/bmRANO/pedRANO,
PCWG, and PCWG3.
• Knowledge of current industry regulations and standards.
• Experience in the oncology therapeutic area.
• Develops imaging document templates as required by operational leadership to create
efficiencies and development of standard look and feel across documents.
• Provides input to Standard Operating Procedures and Work Instruction documents for
the medical writing group as necessary.
• Performs quality control review for other writers as necessary.
• Attends internal technical team and client team meetings as required.
• Serves as medical writing representative on assigned project teams.
• Regularly communicates project related issues with medical and scientific teams and
the project team, as appropriate.
• Mentors and develops junior Medical Writers.
• Participates in other non-billable activities as required, including assistance in
maintaining the medical writing work schedule.
• Strong written and oral communications skills, as well as excellent interpersonal and
• Strong word processing skills including familiarity with MS Office products for
documentation and presentation development.
• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
• Medical/technical writing experience of 5+ years in a clinical research setting.
• Demonstrated understanding of clinical research, the drug development process, and
applicable regulatory guidelines.
• Able to work independently.
• Attention to detail and ability to multitask.