Associate Director, Scientific Operations - JJMT Neurovascular

Associate Director For Scientific Operations

Johnson & Johnson MedTech Neurovascular Division is currently seeking an Associate Director for Scientific Operations. The preferred location for this role is Irvine, California or Galway, Ireland. We are accepting remote candidates within the United States and Europe. This is a remote role available in several countries. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness.

The Scientific Operations (SciOps) Associate Director, will provide strategic oversight and governance to related functions ensuring the delivery of key regulatory and medical documents. Specifically, the Associate Director will lead the strategy and execution of Clinical Evaluations (CERs), State of the Art Assessments (SOA), Literature Reviews, Summaries of Safety and Clinical Performance (SSCP), and Periodic Safety Updates (PSUR) for the MedTech Neurovascular business unit. Furthermore, the Associate Director will lead interactions with the Notified Body and applicable Health Authorities and the drafting and alignment on response strategy and execution.

You will lead a diverse team of managers and medical writers based globally and will ensure the identification and retention of high potential individuals through active engagement, motivation, employee development, and promotion. You will provide leadership and maintain relationships through extensive partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. Additionally, you will lead SciOps activities supporting the Eudamed Readiness strategies for SSCP and PSURs in support of the EU MDR.

Responsibilities

• Lead a team of managers and medical writers to strategize, synthesize and analyze product related safety and performance data, draft reports, coordinate approvals, and when applicable manage submissions to the Notified Body.
• Partner with R&D, Medical Affairs, Clinical, and Regulatory in the establishment of appropriate routes of conformity for clinical evaluations for new products introductions and product design changes and ensure robust data sufficiency strategies.
• Develop and track performance and compliance metrics providing visibility to progress and rising challenges, enabling risk mitigation, corrective and preventive action to be taken as needed.
• Track and trend Notified Body inquiries within business unit to identify trends, improve processes, and increase speed to market. Translate insights into viable processes and solutions that create value.
• Be a member of the MedTech Scientific Operations SOP committee responsible for the effective optimization and harmonization of processes across all MedTech franchises, supporting gap assessments against new regulations, and facilitating implementation plans.
• Generate materials, lead workshops, and deliver training to ensure adequate implementation of guidelines and contribute to the professional development of employees.
• Manage budget and all financial business processes.

Qualifications

Required :

Preferred :