Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

People Leader

All Job Posting Locations:

Albuquerque, New Mexico, United States of America, Albuquerque, New Mexico, United States of America, Atlanta, Georgia, United States, Baltimore, Maryland, United States, Billings, Montana, United States, Birmingham, Alabama, United States, Boise, Idaho, United States, Boston, Massachusetts, United States of America, Burlington, Vermont, United States, Charleston, South Carolina, United States, Charleston, West Virginia, United States, Charlotte, North Carolina, United States, Chattanooga, Tennessee, United States, Chicago, Illinois, United States, Cleveland, Ohio, United States, Concord, New Hampshire, United States, Dallas, Texas, United States, Davenport, Iowa, United States, Denver, Colorado, United States, Detroit, Michigan, United States, Fargo, North Dakota, United States, Green Bay, Wisconsin, United States, Gulfport, Mississippi, United States, Harrisburg, Pennsylvania, United States, Hartford, Connecticut, United States {+ 22 more}

Job Description:

Johnson & Johnson MedTech – Neurovascular Division is currently seeking a 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.

 

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at  

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. Learn more at  

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:

• 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 ( 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.

Job Tags

Permanent employment, Temporary work, Local area, Remote work,

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