
Regulatory Affairs Coordinator
3 days ago
Job Description:
We are seeking a talented Regulatory Affairs Coordinator to join our team at Johnson & Johnson. In this role, you will be responsible for developing and coordinating clinical documents, including protocols, CSRs, and IBs.
Key Accountabilities:
- Develop and coordinate clinical documents, such as Phase 1 protocols, Phase 2/3 CSRs, and IBs.
- Write and contribute to low to medium complexity clinical and regulatory documents, including summary documents and regulatory responses.
- Perform document QC, complete lists of abbreviations or references, conduct literature searches, and perform other basic tasks as needed.
- Participate in and lead cross-functional document planning and review meetings.
Requirements:
- A university/college degree in a scientific discipline is required.
- A minimum of 2 years of relevant pharmaceutical/scientific experience is required.
- A range of 0 to 4+ years of regulatory medical writing experience is required, depending on tasks performed and level of supervision needed.
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