Medical Writer

Investigo are working with a leading Pharmaceuticals company, who are looking for an experienced Regulatory Affairs Medical Writer to work in the global projects team. This position will be located in Princeton, NJ.

The Role

• 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

Experience

• 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
• Ophthalmology experience is preferred but not required

For more information on this role or any others throughout the US, then please reach out to Charlie Seelinger at Investigo on 516-724-7591 or email charlie.seelinger@investigo-us.com