Medical Writer Job at Mastech Digital
Job Description:
Position: Medical Writer
Duration:12+ months with extension
Location: Remote
Job Description:
Regulatory Affairs CMC Technical or Medical Writer
- Must have experience in CMC
- Must have experience in Regulatory Affairs or as Medical Writer in the Pharmaceutical industry.
- Must have experience with Regulatory Submissions to the FDA (IND’s, etc.)
- Here are the main activities we envision the technical writer to support, working closely under the lead
of CMC regulatory:
- IND/IMPD updates
- Writing of M3 for any new INDs
- DSURs/IND/NDA/BLA Annual reports - technical sections, supporting both Reg CMC
and CMC R&D.
- Harmonization of templates across various technical documents within the portfolio.
- Post-approval Mod.3/2.3 updates (reg-cmc variations) - writing of updated sections
- Compliance check of M3 and M2.3 for any NDA/MAA/BLA/IMPD/IND vs source/technical documents
- Writing of responses to the Authorities information requests
- Ensure documents comply with eCTD and internal Menarini-Stemline style requirements.
Job Types: Full-time, Contract
Pay: $65.00 - $70.00 per hour
Schedule:
- 8 hour shift
People with a criminal record are encouraged to apply
Experience:
- Project management: 1 year (Preferred)
Work Location: Remote
Speak with the employer
+91 763-307-4940
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