The opportunity
As a Director, in Global Regulatory Medical Writing (GRMW), you will primarily work in a therapeutic area specific role as a leader and SME representing GRMW in matrixed stakeholder R&D program teams. This role provides a significant level of oversight and SME guidance to internal medical writing team and cross-functional matrixed project teams in the strategic planning, scope determination, and development of clinical and regulatory documents used in drug development and product registrations.
In this role you will offer clear guidance, leadership, accountability for the preparation of quality, fit-for-use clinical regulatory documents for various regulatory and reporting purposes in an E2E business model. As per business needs, you may write and edit clinical regulatory documents, including submission summaries and other complex documents.
How you’ll spend your day
Manage a team of direct reports; oversee contingent workers and/or vendors; provide training to others; strategically analyze needs to manage resources and take accountability for resource allocation for therapeutic specific business needs with support from the department head
Oversee/provide guidance and accountable for all document types prepared by medical writers, review documents internally within medical writing function before stakeholder engagement, may write and edit clinical regulatory documents (all types) as per business needs
Ensure that documents are fit-for-purpose, contain clear and consistent medical/scientific messaging that are accurate and complete, adhere to applicable regulatory guidelines, ICH guidance, and Teva standards
Lead/contribute to the preparation/revision of document templates
Participate in the recruiting/hiring process, development of direct reports including identifying learning/training opportunities, performance assessment and reviews
Responsible for tracking/providing team metrics and establish key performance indicators
