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Business Title
Senior Medical Writer
Requisition ID
EM-MED-W-1002
Job Category
Regulatory Affairs
Locations
USA - Princeton, NJ
Job Description
The ESTERN Medical Regulatory Services Center of Excellence is responsible for ensuring that work undertaken by ESTERN Medical Early and Late Stage Development Services meets the requirements of government regulatory agencies locally and worldwide. This responsibility includes the preparation of a variety of clinical documents including protocols and clinical study reports for Phase I to IV clinical trials run by ESTERN Medical globally, in collaboration with other ESTERN Medical units as necessary.
It is the responsibility of the Senior Medical Writer to prepare such documentation to the required standard in a timely fashion. The Senior Medical Writer is also responsible for providing this service and associated advice to clients. The Senior Medical Writer is expected to acquire a competency in the use of Documentum and associated tools.
Education/Qualifications
BA or BS in life sciences with minimum 8 years relevant experience, MS in life sciences with minimum 5 years relevant experience, or PhD in life sciences with 2 years minimum relevant experience
Experience
Experience in the preparation of clinical documentation
Experience in data handling and data analysis
Good written and verbal communication skills
Ability to write fluent and grammatically correct English
Good word-processing skills
Good organizational and time management skills
Pays attention to detail
Ability to work to tight timelines while maintaining accuracy
Ability to work to a variety of client-driven specifications
Good team player
Familiarity with Quality Assurance and Quality Control procedures
ISS/ISE experience, especially in electronic CTD format.
Experience and track record with IND’s, NDA,s, PMA.s, 510K’s, IDE’s
A plus if fluent in English & Spanish written and verbally.
Qualified candidates should Email their resume, cover letter and desired salary to:
ESTERN Medical, Human Resources
ESTERN Medical is an Equal Opportunity Employer