Our client a NW suburban Boston innovative medical technology company is seeking a Sr. Level Medical Writer to manage the medical writing production for their Clinical Trials Program. This position is a full-time hired position.

Position with coordinate the medical writing processes, development and review of clinical study protocols, synopsis, study procedure manuals, independent review charters and clinical study reports, etc.

Act as medical writing liaison for medical directors, clinical operations, biostatistics and data management and clinical QA and compliance. Manage the review process of all clinical documents, coordinating if needed the roundtable discussions.

Assist biostatistics and regulatory affairs groups in regulatory submissions and in the preparation of abstracts, manuscripts and other presentations for scientific and sales meetings.

Requirements:

R   BS, MS preferred in a Biological or Health-Related Field

R   4+ years of related experience in the life sciences field  Demonstrated proficiency initiating and managing clinical documentation projects

R   Experience in writing clinical protocols, study report, data

R   monitoring charter, blinded read charters, imaging technical

R   documents, manuscripts and publication materials

R   Recent experience in preparation of NDA and IND required.  Familiarity with GCP, ICH and FDA regulatory requirements as they apply to clinical trials

LOCAL CANDIDATES PREFERRED: LITTLE TO NO RELOCATION

Interested?  Email your resume to David@mriweston.com