Medical Writer

Piper Health & Sciences is seeking a Medical Writer to join a clinical research organization (CRO) in the Bethesda, MD area. This role supports medical writing for infectious disease and oncology trials.

Responsibilities for the Medical Writer include:

·       Prepare scientific and regulatory documents on behalf of government and private clients for submission to the Food and Drug Administration (FDA)

o  Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and investigator's brochures, etc.

·       Conduct literature reviews and/or provide summaries of results.

·       Prepare internal and external meeting reports and proceedings, safety documents or data analysis.

·       Contribute to the preparation of technical proposals and responses to technical questions.

Qualifications for the Medical Writer include:

·       1+ years of industry Medical Writing experience related to protocol development, study reports, IB’s, etc. is required.

·       Knowledge of FDA regulations, medical terminology, and analysis of medical research data.

·       Excellent written communication skills.

·       Master’s degree, Ph.D., PharmD, or MD degree in a relevant field is required.

Compensation for the Medical Writer includes:

·       Salary range: approximately $70,000 - $85,000 annually, commensurate with experience

·       Benefits: Cigna Medical, Dental, Vision, ADP 401k

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