Contract Medical Writer

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 is a remote position, however, you must be located near the Boston area.

The Role

• You will be responsible for coordinating, compiling and producing routine regulatory submissions/amendments (IND/NDA)
• You will collaborate with stakeholders globally - clinical, nonclinical/pharmacology, manufacturing, quality, biostatistics, pharmacovigilance
• 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
• Oncology experience is preferred but not essential
• Experience with modules 2.5, 2.7.3, 2.7.4, ISS and ISE is essential

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