Hours Per Week: 40 hours a week
Start Date: September 8-September 22
Duration: 6 months probable extension
Job Description:
Our client has multiple IND’s being filed with a lean staff and needs a medical writing consultant to come in and assist. The ideal candidate will have a minimum of 8 years of industry experience with a scientific background early in their career and moved into medical writing. This candidate will take a lot of non-clinical data and some clinical data and organize it for the IND module 2 section. They have some external contractors who are doing non-clinical work and write up amazing reports, and others that only provide a PowerPoint. This person will need to be able to review everything write full reports then summarize for various parts of the IND. The ideal background of this candidate will be somebody with infectious disease and monoclonal antibody experience who has written module 2’s for INDs, regulatory dossiers, investigator brochures, done preIND meetings, and FDA briefing packages. Pluses for this candidate will be a PhD or advances scientific degree and 3-4 years of development or lab experience showing that you know the science. This candidate cannot be overqualified and ideally will be able to work autonomously with very little guidance
Skills:
- Medical Writing
- IND Module 2
- Infectious disease
- Monoclonal antibody (or biologics)
- Advanced scientific degree
Remote: Medical Writer – Regulatory (238060)
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