Associate Director Medical Writer
Novartis Barcelona
Experteer Overview
In this role you will lead the preparation and oversight of global aggregate reports and risk management plans for a high-priority portfolio. You will work closely with cross-functional teams across QA, medical, and regulatory functions to address health authority feedback and ensure regulatory compliance.You will drive process improvements and mentor associates to strengthen medical safety writing capability. This is a strategic, impact-focused position at the intersection of safety science, regulatory submissions, and cross-functional program leadership.
Compensaciones / Beneficios- Author and independently manage Safety Concerns and critical content in Aggregate Reports and RMPs
- Ensure HA comments are addressed across deliverables with Medical, QPPV, and global stakeholders
- Lead preparation of Aggregate Reports for new products and first risk management plans
- Develop data analysis and presentation strategies for global reports and submissions
- Contribute to cross-functional global projects, including IT initiatives and AI-enabled systems
- Provide expert input on safety document templates and SOPs to meet global regulations
- Assess impact of new processes on deliverables and provide training materials
- Mentor associates and lead capability-building initiatives
- Collaborate with process owners on simplification and improvement initiatives
- Interface with internal and external stakeholders including Health Authorities
- Monitor updates to global PV regulatory requirements and ensure team alignment
- Support trend analyses and risk mitigation in partnership with Compliance & Quality
- Assist with recruitment and deputize for Team Lead as needed
- Contribute to RMP management after appropriate training
- Work primarily in medical writing with potential involvement in RMP management
- Graduate degree in Life Sciences/Pharmacy/Medical Sciences
- Fluent English (oral and written)
- At least 7 years in drug safety/development with minimum 5 years in safety writing
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