• Job title Principal Clinical Safety Specialist- Shockwave Medical (Remote)
• Function Product Safety
• Sub function Drug & Product Safety Operations
• Category Senior Analyst, Drug & Product Safety Operations (P6)
• Location Santa Clara / Minnesota (Any City) / United States of America
• Date posted Feb 19 2026
• Requisition number R-058873
• Work pattern Fully Remote

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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Johnson & Johnson is hiring for a Principal Clinical Safety Specialist– Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

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 https://www.jnj.com/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Principal Clinical Safety Specialist will have primary responsibility for study or program oversight, ensuring all aspects of safety are conducted according to procedure and in a compliant manner. The Principal Clinical Safety Specialist may oversee one or more studies, assuming ownership for study-specific requirements. This may include special projects, process development, vendor oversight, audit participation, and providing advisory to the clinical and post-market surveillance teams. In addition, the Principal Clinical Safety Specialist will be responsible for providing backup support for adverse event collection and processing, safety monitoring, maintenance of study-specific Safety Management Plans, and participation in writing and/or reviewing safety sections of clinical study documents. This may also include management of Clinical Events Committee(s) and Data Safety Monitoring Board(s).

Essential Job Functions

• Assumes wholistic responsibility for safety management and monitoring for one or more clinical studies, including:
  • Establishment of end-to-end safety documentation system; development of study-specific plans, procedures and data entry guidelines
  • Compliance with pre-market regulatory reporting of Serious Adverse Events (SAEs) and Device Deficiencies (DDs)
  • Assurance of high-quality safety data collection o Provision of direction and guidance to safety vendor(s), escalating vendor management issues as appropriate
  • Management of Clinical Events Committees (CEC) and Data and Safety Monitoring Boards (DSMB) o Serving as liaison and advisor to the post-market surveillance team to resolve complaints related issues
  • Use of appropriate medical and regulatory judgement in escalating any safety concerns
• In addition, the Principal Clinical Safety Specialist may provide support for any of the following:
  • Review, evaluation of, and tracking of incoming adverse events (AEs) including follow-up of ongoing events o Collaboration with sites/monitors/Contract Research Organization (CRO) to ensure comprehensive information is available for full review of adverse events
  • Drafting or review of SAE narratives o Distribution and notification of AEs to appropriate teams and clinical sites, as needed o Liaison for safety-related questions from Clinical Affairs, CRO, monitors, Field Clinical Specialists, post-market quality, surveillance, etc.
  • Verification of consistency and compliance in application of protocol definitions for adjudication outcomes
  • Providing input to the development and management of study related documents including clinical protocols, case report forms, monitoring plans, study manuals, and other study tools related to adverse event reporting and definitions
  • Assistance with preparation of safety reporting for annual reports, clinical study reports, investigator brochure updates, and other documents as required
• Maintains knowledge of current FDA, ISO, competent authority, IRB, REB, and EC regulatory rules and policies affecting AE reporting
• Assists in training of study personnel regarding the adverse event definitions per protocol
• Collaborates on additional Clinical Affair’s activities, as required
• Other duties as assigned

Qualifications

• RN or equivalent healthcare experience, with Bachelor’s degree preferred
• Minimum 10+ years’ experience in clinical safety or combined clinical safety/post-market vigilance experience, with prior clinical research experience preferred
• Experience in cardiovascular disease preferred
• Experience with medical device clinical studies preferred
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
• Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.)
• Good prioritization and organizational skills
• High attention to detail and degree of accuracy
• Familiarity with electronic data capture (EDC) systems
• Operates both as a team and independently, with adaptability to changing requirements
• Experience coordinating, prioritizing, setting timelines, and multi-tasking
• Expertise with medical device regulations and compliance guidelines for clinical studies including ISO 14155, 21 CFR 812, EU MDR and other relevant guidance documents
• Position requires approximately 10% travel

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.

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