Company Info

Job Description

A Senior Director in Global Regulatory Medical Writing & Data Transparency and Disclosure 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 companys global strategic, scientific, regulatory, and commercial goals. The Senior Director offers 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. The Senior Director provides mentoring and proficiency to manager-level direct reports.

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

Function

Sub Function

Reports To

Senior Director Head of Global Statistics

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