Expert Medical Writer Needed

Based out of the United States, we offer medical and beauty solutions to customers worldwide. We are looking for a Medical Writer who researches, writes, and edits nonclinical, clinical, and/or regulatory documents for submission to regulatory agencies (e.g., U.S. Food and Drug Administration/FDA). An expert nonclinical study protocol writer, preferably with experience in the medical device industry, who can quickly create a product performance testing protocol, following 21 CFR Part 58 guidelines. English-speaking candidate only.

Requirements:
- Understands the Medical Device performance testing process
- Understands the intended clinical use of the test article being tested
- Experience writing uncomplicated (routine) nonclinical study designs and product performance testing protocols
- Develops testing strategy; troubleshoots test article preparation issues
- Ensures all applicable Good Laboratory Practice (GLP) regulations are considered

Technical Competencies:
- Knowledge of Good Laboratory Practices for Nonclinical Laboratory Studies (21 CFR Part 58)
- Knowledge and experience with medical writing and protocol writing
- Awareness of federal guidelines and regulatory bodies including, but not limited to FDA, ISO, and ICH
- Demonstrated knowledge of laboratory procedures, analysis of scientific data, technical writing, organizational and communication skills
- Proficient in Microsoft Office (Word, PowerPoint, Excel)
- Excellent writing, grammar, spelling, and formatting.

Qualifications and Skills:
- Demonstrated Science background
- 1-3 years of experience in medical writing
- Fluency in English required
About the recuiter
Member since Aug 25, 2017
Craig M.
from California, United States

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