Investigo are working with a leading Pharmaceuticals company, who are looking for an experienced Regulatory Affairs Medical Writer (contract) to work in the global projects team. This position will be located in Princeton, NJ.
- You will be responsible for coordinating, compiling and producing routine regulatory submissions/amendments (IND/NDA)
- You will be responsible for tracking timelines on regulatory deliverables as well as providing project updates - this will include highlighting any risks that might impact the ability to achieve corporate goals
- You will ensure that all regulatory submission documents are fully compliant with internal document standards
- You will work with the wider team to ensure that all regulatory practices are fully integrated in all pre-clinical, clinical and technical submissions, and evaluate all documents submitted to the FDA to ensure they are complete, well organized, scientifically accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review
- You must have a Bachelor's degree and Master's degree - higher (PhD, MD, PharmD) is preferred
- 5+ years of regulatory experience in the biotech/pharmaceutical industry
- Oncology experience is preferred but not required