Director, Medical Writing

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.

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 into 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 (Ph.D., MD, PharmD) is highly preferred


• 10+ years of regulatory experience in the biotech/pharmaceutical industry


• Oncology experience is required


• Experience with modules 2.5, 2.7.3, 2.7.4, ISS, and ISE are essential

If interested in learning more, please contact Bria Gaber at (see below) or call for more information.