PRAHS

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2017-43120

2017-43120

Title 
Principal Medical Writer- Home based
Job Locations 
-
US-Remote
Posted Date 
10/22/2017

More information about this job

Overview

Researches, writes, and edits clinical documents by applying functional expertise and clinical drug development knowledge.

Responsibilities

•    Acts as a lead medical writer on numerous programs and individual studies at a moderate to complex level.
•    Provides scientific and medical writing consultancy to clients and internal colleagues at a complex level.
•    Leads project teams in drafting report specifications, medical writing, and coordination of regulatory submissions and data analysis.
•    Manages all aspects of the medical writing function, including line management. 
•    Serves as an active mentor to all levels of medical writing personnel. 
•    Develops and implements training for medical writers.
•    Oversees operational activities of other medical writers as the project team leader.
•    Conducts in-service training for clinical research associates, other clinical functions, and clients in areas of therapeutic expertise. 
•    Provides bid estimates for medical writing work for potential projects and attends bid defense meetings when requested.

Qualifications

5- 10 years of Regulatory medical writing experience

  • Experience with China submissions
  • Experience with Japan submissions
  • Experience writing as a lead author at least 2 items in the list below
    • NDA
    • CTD
    • IND
    • DSUR
    • Briefing packages
    • PIP/PSP
    • IB

Minimum Bachelor's Degree - doctoral candidates  (PhD, MD, PharmD) strongly preferred.  

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

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