Principal Clinical Safety Specialist - Shockwave Reducer

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 Job Function Product Safety Job Sub Function Drug & Product Safety Operations Job Category Professional All Job Posting Locations: New Brighton, Minnesota, United States of America, Santa Clara, California, United States of America Job Description Johnson & Johnson is hiring for a Principal Clinical Safety Specialist– Shockwave Reducer to join our team located in New Brighton, MN. 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 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) 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 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 Distribution and notification of AEs to appropriate teams and clinical sites, as needed 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 Requirements 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 Pay Transparency The anticipated salary range for this position is $121,000 - $194,350 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. https://www.careers.jnj.com/employee-benefits 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 : $121,000 - $194,350