Job Description
SUMMARY: The primary responsibility of the Regulatory Writer is to support the Regulatory Writing Department at an entry level. The
Regulatory Writer will
perform routine regulatory writing tasks including, but not limited to document authorship, quality assurance/control (QA/QC) activities, and
with oversight,
the coordination of QA/QC staff and delegation/acquisition of QA/QC resources. The Regulatory Writer may also support presales activities and
contribute
to the ongoing efforts of business development and general growth and stability of the department.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Writes and/or edits regulatory documents under supervision including, but not limited to, protocols, investigator brochures, informed
consent forms,
nonclinical and clinical study reports, Module 2 summaries, and Module 1 administrative components.
- Performs QA/QC activities per company policy.
- Coordinates QA/QC staff and delegation/acquisition of QA/QC resources under supervision.
- Establishes and maintains a working knowledge of global (ICH) and local (EMA) regulations and guidances.
- Documents work according to company procedures and work practices.
- Maintains accurate records of time spent on client projects.
Requirements
- Bachelor’s degree in biology, chemistry, life science, English, technical writing or associated discipline from a 4-year college or university,
or
equivalent combination of education and experience. Advanced degree (MD, PhD, PharmD, or other equivalent) strongly preferred.
- Familiarity with the AMA Manual of Style or other regulatory writing styles is desirable.
- Sufficient experience in writing and/or editing regulatory submission documents is required.
- Experience with authoring for electronic submissions is desirable.
- Familiarity with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), ICH Guidelines E3 and E6, and FDA Guidance/ICH
Guidelines on
electronic submissions is desirable.
Company offers
