Description

The Senior Quality Control Associate provides a thorough quality control (QC) review of regulatory documents and medical communications to support all phases of product development.

These documents include, but are not limited to, clinical study reports, study protocols, subject safety narratives, informed consent documents, investigator’s brochures, clinical and nonclinical sections of regulatory submissions, and manuscripts.

Qualifications

• Bachelor’s degree required; science-related field preferred.
• Minimum of 3 years of experience working in a life science or clinical research environment, preferably in a contract research organization (CRO) or pharmaceutical/biotechnology setting. Medical/technical writing experience and/or experience in a QC function is essential.
• Excellent command of the English language (grammar, spelling, English usage, punctuation), ability to focus and maintain a high level of attention to detail, strong interpersonal and communication skills, and ability to function collaboratively in a team environment are mandatory.
• Experience with Microsoft Office Suite is essential, including advanced Microsoft Word proficiency.
• Familiarity with medical terminology and statistical concepts preferred.