Regulatory Affairs Medical Writer
2 weeks ago
Join Our Innovative Team
ImmunityBio is seeking a skilled Medical Writer to enhance our documentation efforts. In this role, you will be tasked with producing high-quality regulatory submissions, including clinical study reports, protocols, and informed consent documents. You will work closely with various teams to ensure that all materials are accurate and comprehensive. This position offers a competitive salary along with a robust benefits package.
Key Responsibilities
- Draft regulatory documents, such as clinical summaries and study protocols
- Collaborate with multidisciplinary teams to collect source data
- Ensure compliance with eCTD submission standards
- Facilitate document review meetings
- Offer insights and solutions for document content
Qualifications
- Bachelor's degree in a relevant scientific discipline is required
- Experience in NDA submissions and regulatory writing is essential
- Strong expertise in oncology or related fields
- Familiarity with AMA writing standards and FDA/EMA/ICH regulations
What We Offer
- Comprehensive Medical, Dental, and Vision Insurance
- Health and Financial Wellness Programs
- 401(k) Retirement Plan with Company Matching
- Generous Paid Time Off, including holidays
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