Principal Clinical Safety Specialist- Shockwave Medical (Remote)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

Job Function:

Product Safety

Job Sub Function:

Drug & Product Safety Operations

Job Category:

Professional

All Job Posting Locations:

Minnesota (Any City) Santa Clara California United States of America

Job Description:

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 by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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 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 Affairs activities as required
• Other duties as assigned

Qualifications

• RN or equivalent healthcare experience with Bachelors 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 ISOCFR 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 () or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Advanced Analytics Analytical Reasoning Clinical Operations Communication Critical Thinking Medicines and Device Development and Regulation OSHA Compliance Problem Solving Process Oriented Quality Control (QC) Risk Compliance Safety Investigations Safety-Oriented Scientific Research Serious Adverse Event Reporting Standard Operating Procedure (SOP)

The anticipated base pay range for this position is :

$125000.00 - $201250.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys 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: - Experience:

Staff IC