Medical Writer

Confidential Company  •  Milpitas, CA

5 - 7 years experience  •  Technology

Salary depends on experience
Posted on 07/10/18 by Cynet EngineeringTeam
Confidential Company
Milpitas, CA
5 - 7 years experience
Technology
Salary depends on experience
Posted on 07/10/18 Cynet EngineeringTeam

??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."

Job Description:

  • MEDICAL WRITER- Clinical Affairs- Clinical Evaluation Reports 
  • Min 5 - 8 year of exp

Required Skills:

  • 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.

Preferred Skills:

  • 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 

Education:

  • BE / BS

Industry:

  • Medical
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