Associate Director of Scientific Operations

Johnson & Johnson MedTech Neurovascular Division is currently seeking an Associate Director of Scientific Operations. The preferred location is Irvine, California or Galway, Ireland. This role is open to remote candidates within the United States or 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.

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:

• Minimum of a Bachelor's degree (University Degree), in Life Sciences, Engineering or related subject area.
• Minimum of 8 years of experience in a regulated environment including five years of direct experience with medical devices in the fields of technical or medical writing, post market surveillance, clinical research, or product risk management.
• Minimum of 2 years of people leadership experience.

Preferred:

• Knowledge on physiology and common outcomes of neurovascular diseases and events
• An advanced degree, MS, PhD, RN, or MBA.
• Process Excellence / Six Sigma training or certifications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center at ra-employeehealthsup@its.jnj.com or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $137,000 - $235,750. Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year Holiday pay, including Floating Holidays up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.