Medical Writer I - Medical Imaging

About the role

Prepare documentation for Blinded Independent Central Review (BICR) implementation for clinical trials
Understand the imaging aspects of sponsor clinical protocols
Understand image acquisition modalities
Understand image assessment criteria
Independently write and finalize Medical Imaging documents, including:
Site Imaging Manual (SIM)
Independent Review Charter (IRC)
Independent Review Training Manual (IRTM)
Liaise with internal groups, i.e., Medical and Scientific Affairs, Imaging Operations, and Clinical Operations to obtain necessary and relevant information and to deal with queries
Independently interact with sponsors to obtain necessary information and deal with queries through effective decision making
Inform the Manager-Medical Writing/designee of document status relative to quality and timelines
Independently provide additional writing and editing services as required

Requirements

Advanced degree in a scientific discipline, preferably PhD, PharmD or MD
2+ years of professional experience in Medical Writing at a pharmaceutical, biotechnology, CRO or other health care setting
Knowledge of imaging guidelines for clinical trials, such as the FDA âClinical Trial Imaging Endpoint Process Standards Guidance for Industryâ
Strong written and verbal interpersonal skills
Good computer literacy
Ability to work effectively and cooperatively with cross-functional teams

Qualifications

A desire to be a key part of a global network of services that lead to better outcomes for its clients, its people and for patients

Skills

N/A

Benefits

N/A

Pay

N/A

Schedule

N/A