Medical Writer

  • location: Lexington, MA
  • type: Contract
  • salary: $34.31 - $40.37 per hour
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job description

Medical Writer

job summary:
Technical Writer II

Job Summary

This role is supporting Medical Devices at the client

 
location: Lexington, Massachusetts
job type: Contract
salary: $34.31 - 40.37 per hour
work hours: 8 to 4
education: Bachelors
 
responsibilities:
Job Responsibilities

  • Under the direction of the line manager and DDL, the Technical Writer is responsible for preparation of high quality device/combination product regulatory submissions and a wide range of supporting documentation across the device development lifecycle including:

    • pipeline programs (IMPD/CTA/IND)
    • Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for informationn
    • Briefing Books
    • Post- Approval changes or compliance updates across all global franchises.
    • In addition the Technical Writer will also be expected to drive, support and contribute to broader improvement initiatives that contribute to the client's overall success.
  • This person will support the "submission"
  • They need a tech writer to do drafting
  • They need this writing to be consistent according to their SOP's and they need to make sure their documents a flowing and look uniform
  • These are the submissions to the FDA and they need the tech writer to come in and make sure the submissions are "uniform" and all written the same way
  • Tech writer is supposed to harmonize these documents so they flow correctly and look like they were written by the same individual
  • This person needs to understand the content and make sure it's cohesive
 
qualifications:
Education & Qualifications

  • Biotech/pharma is preferred
  • Someone coming from devices (med devices) would be fine too
  • Submissions experience and writing experience
  • 5-8 years would be sufficient
  • Systems: mainly client specific so they will be trained when they start as long as they know Microsoft and know formatting
 
skills: Editing, IND, NDA, SOP, FDA, Maa, CTA, JNDA
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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