Medical Writer

PDS Tech, Inc. is seeking a Medical Writer in Indianola, PA

Position Summary:
  • Provide needed support in taking full responsibility for Clinical Evaluation Planning/Reporting, providing input to Risk Management for the annual Periodic Safety Update Reporting, health risks associated with complaints/quality issues, and audit support for radiology devices.
Position Duties and Responsibilities:
  • Write clinical literature search protocols, including determining appropriate search terms for device safety and performance and state of the art.
  • Write clinical literature search reports based on analysis of the literature search results, including scoring the publications, summarizing the outcomes, and relating the data to the device safety/performance or state of the art.
  • Write clinical evaluation plans (CEPs) and Clinical Evaluation Reports (CERs), describing in detail the available pre-clinical (verification & validation) data, clinical data, and post-market clinical follow-up plan.
  • Support audits when necessary
  • Support quality issue and health risk assessments with medical input and potential impact

 
Requirements/Preferences:
  • Education Minimum Requirement - Bachelors Degree
  • Education Preferred - Ph.D.
Skills & Competency Requirements:
  • A minimum of 5 years of experience in medical devices.
  • Directly authored clinical evaluations (reports and plans) to meet EU MDR requirements.
  • High level of ambition and self-direction.


PDS Tech, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Founded in 1977, PDS Tech, Inc. is one of the nation's premier specialty staffing firms with 31 offices nationwide. We offer a full range of benefits including:

  • Health insurance
  • Paid holidays
  • Weekly payroll
  • Immediate 401(k) eligibility
  • Completion Bonuses
  • Training
  • Please note availability of benefits may vary by position

PDS specializes in Engineering and IT arenas including Aerospace, Defense, Electronics, Telecommunications, Automotive, and Energy just to name a few. Our reputation, track record, and years of continuous growth reflect the commitment to quality that our employees and clients experience first-hand. To find out more about PDS, please visit www.pdstech.com



$$$ PDS pays for referrals! $$$

Company
PDS Tech, Inc.
Posted
10/06/2021
Type
Full time
Salary Range
$65,000.00 - 114,000.00
per Year
Salary range estimated by
Location
Indianola, PA 15051, US
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