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.