North AmericaFull TimeOther
Remotely
gcpmedical writingclinicalregulatory writingcontentbiopharmaceuticalregulatoryich
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Job Description
📋 Description
- Prepare clinical and regulatory documents for AbbVie drugs/devices.
- Autonomy on drafts with review by SMEs and senior writers.
- Coordinate review/approval and QA of regulatory projects.
- Produce regulatory docs with focus on quality and timelines.
- Learn submission strategies for US/international regs.
- Contribute to tactical process improvements.
🎯 Requirements
- 4+ years bio-pharma industry experience in global pharma/biotech.
- Bachelor's degree or higher; scientific discipline preferred.
- Excellent written and oral communication; strong medical terminology.
- Proficient in analyzing complex data.
- Experience writing/editing clinical/regulatory docs (ICH, GCP); EU/US device writing a plus.
- Understanding of drug development, study designs, biostatistics, regulatory requirements.
🎁 Benefits
- Competitive benefits including PTO, medical/dental/vision and 401(k).
- Eligible for short-term incentive programs.
- AbbVie is an equal opportunity employer.
