Careers at ESTERN Medical


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 hr@esternmedical.com

ESTERN Medical is an Equal Opportunity Employer