Principal Medical Writer (work from home)
The Principal Medical Writer researches, writes and edits clinical reports, summarizing statistical data from clinical studies, writes clinical study protocols, clinical plan outlines and sections of regulatory submission documents by applying therapeutic expertise and clinical drug development knowledge and relevant experience to the development of drugs, biologics, devices and or other products for human use.
Responsibilities:
Acts as a Lead medical writer on a program, numerous individual studies, or other projects at a simple to complex level.
Acts as Lead medical writer on simple to complex submissions projects.
Provides leads for Business Development opportunities.
Minimum Qualifications
Substantial experience in pharmaceutical or CRO industry developing pharmaceutical drugs for human use required e.g. non-clinical science, medical related writing, protocol writing, writing for regulatory submissions, clinical trials management, monitoring, or as an investigator or sub-investigator for clinical trials
Substantial experience writing clinical study reports, other regulatory submission documents, poster presentations, and manuscripts for publication in a scientific journal required
Experience using computerized systems (PC-Windows, and MS Office) required
Knowledge of regulatory agency requirements for protocols and regulatory submissions in the host country required
Direct or indirect experience interacting with FDA or host country regulatory agency required
Demonstrated project leadership skills required
Read, write and speak English; fluent in host country language required
In addition to the above must have experience complex science or medical related writing experience required
An advanced degree (M.S., PharmD, Ph.D.) from an accredited institution in science or a health-related field, or equivalent international education preferred. Bachelor’s degree in scientific, health-related or journalism/ communications required
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
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
CLICK TO APPLY TODAY!
Principal Medical Writer
Responsibilities:
Acts as a Lead medical writer on a program, numerous individual studies, or other projects at a simple to complex level.
Acts as Lead medical writer on simple to complex submissions projects.
Provides leads for Business Development opportunities.
Minimum Qualifications
Substantial experience in pharmaceutical or CRO industry developing pharmaceutical drugs for human use required e.g. non-clinical science, medical related writing, protocol writing, writing for regulatory submissions, clinical trials management, monitoring, or as an investigator or sub-investigator for clinical trials
Substantial experience writing clinical study reports, other regulatory submission documents, poster presentations, and manuscripts for publication in a scientific journal required
Experience using computerized systems (PC-Windows, and MS Office) required
Knowledge of regulatory agency requirements for protocols and regulatory submissions in the host country required
Direct or indirect experience interacting with FDA or host country regulatory agency required
Demonstrated project leadership skills required
Read, write and speak English; fluent in host country language required
In addition to the above must have experience complex science or medical related writing experience required
An advanced degree (M.S., PharmD, Ph.D.) from an accredited institution in science or a health-related field, or equivalent international education preferred. Bachelor’s degree in scientific, health-related or journalism/ communications required
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
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
CLICK TO APPLY TODAY!
Principal Medical Writer
