About
We are searching for an experienced medical, scientific, and regulatory and scientific writer. We require assistance in preparing multiple regulatory documents including pIND briefing books, scientific research publications, IB, clinical study protocols, ODD to support multiple regulatory interactions, IND opening, and future clinical trials.
We have raw data from our preclinical reports and the urgent need is for someone to compile all this information into a pre-IND briefing book packet.
The briefing book will need to be finalized by the first half of September.
Responsibilities
- Preparing pre-IND briefing book and other regulatory submissions for biologic
- Assist in writing clinical protocols, synopses, IBs, and ICFs
Ideal Candidate
Skills
Functional Areas
Medical Writing
Therapeutic Areas
Neurology
Development Phases
Pre-clinical
Discovery
Regulatory Pathways
IND
BLA
Qualifications
Education
- PhD (Doctor of Philosophy)
- MS (Master of Science)