Principal Clinical Safety Specialist- Shockwave Medical (Remote)

Johnson & Johnson Innovative Medicine•Santa Clara, CA

13d•Remote

About The Position

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).

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

Responsibilities

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
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

Benefits

Subject to the terms of their respective plans, employees are 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.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits