Ascendis Pharma Benefits Overview

Leads complex GRAPS projects and programs across Regulatory Affairs, Patient Safety, and enterprise functions. Establishes governance, integrated plans, budgets, risk controls, reporting, and decision pathways; coordinates stakeholders, vendors, resources, and change initiatives. Ensures quality, compliance, inspection readiness, and scalable operating practices while communicating status and recommendations to executives. Provides coaching to workstream leads and junior project managers.

Develop and improve metadata-driven SDTM programming solutions for clinical trials. Responsibilities include creating and validating SDTM datasets, optimizing metadata, reviewing clinical data and specifications, supporting quality control, and ensuring regulatory-compliant, inspection-ready deliverables. The role collaborates with international cross-functional teams within a pharmaceutical biometrics organization.

Develops and implements global regulatory strategies across clinical, non-clinical, and CMC disciplines. Leads complex regulatory submissions, clinical and regulatory planning, risk mitigation, labeling, and cross-functional collaboration across international teams. Maintains regulatory expertise, assesses global requirements, influences project teams, and may mentor or supervise regulatory professionals. Requires extensive experience with regulatory dossiers, including CTAs, IMPDs, and INDs, plus knowledge of international regulatory requirements and trends.