Director Medical Writer

Director of Medical Writing

New Jersey - United States

Seeking an experienced Director of Medical Writing to join a growing, late-clinical stage, oncology pharmaceutical group in New Jersey. You'd be working with a leading Pharmaceuticals company, who are looking for an experienced Regulatory Affairs Medical Writer to work in the global projects team. *This is a permanent position and you must be local to the New Jersey site.

Responsibilities:

• You will be responsible for leading, 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

Requirements:

• You must have a Bachelor's degree and Master's degree - Advanced degrees (PhD, MD, PharmD) is highly preferred
• 10+ 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 are essential

If interested in learning more, please contact Charlie Seelinger at charlie.seelinger@investigo-us.com

or (516) 724-7591 for more information.