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:

Alabama (Any City), Alabama (Any City), Arizona (Any City), Arkansas (Any City), California (Any City), Colorado Springs, Colorado, United States of America, Connecticut (Any City), Danvers, Massachusetts, United States of America, Delaware (Any City), Florida (Any City), Georgia (Any City), Idaho (Any City), Illinois (Any City), Indiana (Any City), Iowa (Any City), Kansas (Any City), Kentucky (Any City), Louisiana (Any City), Maine (Any City), Maryland (Any City), Michigan (Any City), Minnesota (Any City), Mississippi (Any City), Missouri (Any City), Montana (Any City) {+ 20 more}

Job Description:

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Clinical Safety Specialist. This is a remote role available in the continental USA.

Purpose: The Clinical Safety Specialist is responsible for implementing and executing clinical trial safety activities and responsibilities for the clinical research programs.

You will be responsible for:

• Management of safety related clinical trial activities for assigned studies including:
  • Ensure timely and accurate execution of all safety related processes (study-specific) per study Safety Management Plan (SMP) and applicable Charters
  • Conduct ongoing medical reviews of safety related events (e.g., AEs, DD/DMs) per study SMP
  • Manage safety related processes:
    • Develop, implementation and ongoing management of study-specific Safety Management Plan (SMP) and Case Report Forms (e.g., AE, DD/DM, and Adjudication CRFs) and Charters
    • Review of draft informed consent forms (templates and site specific)
    • Safety requests for and review of source documents
    • Issuing and resolving safety queries in the study database
    • Event reconciliation between EDC and Quality Assurance/Complaints
    • Manage activities related to study committees (CEC, DSMB/DMC, Independent Medical Monitor) or overseeing third party management of committee activities per study SMP and associated Charters
  • Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations or overseeing activities of third-party managing safety reporting.
  • Review applicable study reports and statistical outputs as needed
  • Other clinical trial safety activities as directed
• Support the review, implementation, and execution of standard operating procedures (SOPs)
• Contribute to the development and implementation of medical safety program initiatives, process improvements and sound safety practices

Qualifications:

• Bachelor’s Degree required, preferably in nursing. healthcare or life sciences
• Minimum of 5 years’ experience implementing safety processes or clinical research experience including management of safety events (medical devices preferred)
• Must have clinical research experience
• Experience managing and execution of processes for CEC and DSMB/DMC preferred
• Experience with complaint handling, quality & regulatory processes preferred
• Strong interpersonal skills and well-developed written and oral communication skills
• Effective analytical and problem-solving skills
• Proficiency in guidelines, standards and regulations that are applicable to medical devices and medical device clinical trials, including 21CFR803, 21CFR812, MDCG 2020-10/1,, ISO 14155, EU MDR 2017, and country-specific regulatory requirements
• Knowledge and proficient use of Microsoft Office Suite Applications (Word, Excel, Power Point, and Microsoft Project) and clinical trial databases (e.g., Medidata Rave, Argus)

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers internal employees contact AskGS to be directed to your accommodation resource.

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The anticipated base pay range for this position is :

$91,000-$147,200

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits