Description: Our client is currently seeking a Medical Writer
The Medical Writer is responsible for the preparation of documents that support various departments, including Clinical, Regulatory, and Scientific.
This job will have the following responsibilities:
The Medical Writer is responsible for clinical content creation, including the preparation of clinical study protocols, protocol amendments, consent forms, documents for regulatory submissions, interim study reports, newsletters, presentations, final CSRs and other material based on clinical trials and registries.
Writes/reviews scientific manuscripts, congress abstracts, and scientific meeting presentations aligned with journal and congress guidelines.
Write IND modules, NDA modules and other related regulatory documents.
Write clinical study reports, protocols, and protocol amendments.
Coordinate quality control reviews of those documents and maintain audit trails of changes.
Helps review documents related to clinical trials and registries to ensure appropriate evaluation and presentation of data, methodology, interpretation, and documentation.
Qualifications & Requirements:
BA/BS Degree in the Life Sciences required (Advanced preferred)
Experience working within Medical Device or Pharmaceutical Industry in Medical Writing and/or Clinical Research with a focus on Medical Writing
Contact: arawat@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
