??We are looking for Medical Writer for our client in Milpitas, CA
Job Title: Medical Writer
Job Location: Milpitas, CA
Job Type: Contract - 12 Months / Contract to Hire / Direct Hire
"US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time."
- MEDICAL WRITER- Clinical Affairs- Clinical Evaluation Reports
- Min 5 - 8 year of exp
- Responsible for writing and maintaining Clinical Evaluation including writing and editing data from clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, and other projects requiring skill in medical communication.
- Compiles, analyzes, and summarizes additional data from other sources as needed.
- Prepares literature reviews for new products and revises existing literature.
- Writes and maintains files on informative journal abstracts according to current or estimated future needs.
- Collaborate with clinical, R&D, quality assurance, regulatory and marketing teams on clinical study reports, clinical investigation plans, investigator brochures, evidence gap assessments, marketing brochures, post-market surveillance reports, risk management documents and other documents that require the evaluation of clinical data and/or clinical literature.
- 5+ years of experience as a Clinical Research Associate, Clinical Project Manager or equivalent external position
- Bachelor's degree (e.g., MS, MA, MPH, PharmD, PhD, DVM or MD) in a scientific field of study.
- Strong knowledge of regulatory guidance relative to Clinical Evaluation Reports, and the essential requirements for safety and performance of Medical Devices
- Medical device industry experience/Clinical research experience
- Demonstrated clinical regulatory experience including knowledge of applicable US and OUS regulations and clinical data requirements, and preparation of clinical sections of regulatory submissions for FDA and international agencies.
- Ability to perform all assigned tasks, work independently, and complete work on schedule
- Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization
- efficient management of time and resources
- BE / BS