Principal Medical Writer

Principal Medical Writer:

The Principal Medical Writer is able to assist the department management team in achieving and maintaining the highest standards of excellence across all medical writing project activities and is able to be an operational ambassador for the medical writing department in external and internal settings. The Principal Medical Writer independently writes, edits and compiles documents that are components of clinical/regulatory marketing approval applications for new biologics, drugs, or devices, and directs other Medical Writers in the writing, editing and compilation of documents. The Principal Medical Writer recognizes, exemplifies and adheres to ICON's values which centers around our commitment to People, Clients and Performance. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

Key responsibilities include the following:

• Assists in the management of medical writing resources.
• Interprets clinical data.
• Writes protocols, investigator brochures, periodic safety reports, clinical study reports and other regulatory documents.
• Writes and manages NDA, PMA, BLA, IDE, and IND documents (both preclinical and clinical reports of clinical studies).
• Provides additional writing and editing services as required (e.g. for publications).
• Advises on the content and format requirements for clinical reports and regulatory documents.
• Performs quality control (review) of documents and assesses whether specific project related documents comply with regulatory requirements, client requests and ICON SOPs.
• Participates in non-project specific activities, including assistance in maintaining the medical writing work schedule.
• Responsible for the daily management of assigned medical writing projects.
• Liaises with Project Managers and Biostatisticians to ensure the timely implementation of activities related to the production of reports.
• Keeps Medical Writing Management informed of project status (e.g. in relation to quality, timelines, progress, and problems).
• Interaction with clients regarding scientific and technical aspects of projects
• Participates in the training and supervision of new and junior Medical Writers.
• Represents Medical Writing at internal and external meetings.
• Assists Business Development with the preparation of proposals and cost estimates for medical writing tasks.