The opportunity
This is a remote opportunity and candidate can sit anywhere in Germany.
A Director, in Global Regulatory Medical Writing, reports into Head of Global Regulatory Medical Writing, will primarily work in therapeutic area specific/functional 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. The Director offers 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, may write and edit clinical regulatory documents, including submission summaries and other complex documents, as well as resource and budget management
How you’ll spend your day
Primarily works on the therapeutic area/functional level
Likely to have direct reports; oversees contingent workers and/or vendors; provides training to others; strategically analyzes needs to manage resources and is accountable for resource allocation for therapeutic specific business needs with support from department head
Oversees/provides 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
Ensures that documents are fit-for-purpose, contains clear and consistent medical/scientific messaging that are accurate and complete, adheres to applicable regulatory guidelines, ICH guidance, and Teva standards
Leads/contributes to the preparation/revision of document templates
Participates 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
