Clinical Technical Writer
Global Channel Management, Inc.
Madison , NJ 07940
Posted 1 week ago
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Clinical Technical Writer needs 2 years' experience in Regulatory Affairs experience
Clinical Technical Writer requires:
- Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
- 2+ years of experience in pharmaceutical research and development or regulatory affairs
- 1+ years of CMC regulatory experience is desirable
- Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions
- Strong working knowledge of manufacturing unit operations
- Familiarity with US and other international regulatory requirements for drug product dossier
Clinical Technical Writer duties:
- Prepare, coordinate, and manage the chemistry, manufacturing, and control (CMC) documents for annual reports (IND and NDA).
- With supervision prepare CMC documents for use in routine US and ex-US regulatory filings.
- Provide guidance on use of submission document templates.
- Provide assistance on department related assignments and projects.
- Identify and communicate routine CMC issues.
Collaborate with diverse functional groups to ensure fileability and acceptance