The opportunity
The Senior Director in Global Regulatory Medical Writing & Data Transparency provides leadership, direction, and competence to a team of medical writers/managers and electronic document specialists within Clinical Specialty Development for the production of high-quality clinical research documentation, which adheres to departmental standards and regulatory guidelines in support of drug development, product registrations, and product marketing to meet the company’s global strategic, scientific, regulatory, and commercial goals.
The Senior Director will also:
offer clear leadership and extensive accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents. He or she serves as a liaison among internal/global functional groups to ensure optimal use of resources in making medical writing support available for all projects.
Provide mentoring and proficiency to manager-level direct reports.
Location: This is a hybrid opportunity that can be based out of our Parsippany, NJ or West Chester, PA offices
Your experience and qualifications
PhD in life sciences (or other related field) with a minimum of 10 years of experience related to medical writing OR Masters in life sciences (or other related field) with a minimum of 15 years of experience
Expert/Mentor at global function level to management-level staff
Highly skilled at setting regulatory medical writing processes/policies and technical and editorial standards
Considered an internal expert in all aspects of regulatory medical writing, T&D, and clinical drug development
Knowledge of global regulations and guidelines for T&D and document submissions
