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/.   Johnson & Johnson's MedTech focused on cardiovascular health, is recruiting for a Clinical Safety Specialist , located in Danvers, MA or Remote. Remote work options may be considered on a case-by-case basis and if approved by the Company. The Clinical Safety Specialist is responsible for implementing and executing clinical trial safety activities and responsibilities for the clinical research programs. Job Responsibilities: 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) This job posting is anticipated to close on February 24, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications. The anticipated base pay range for this position is 105,000 to 169000. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. 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)). + 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 of 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 The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market." \#LI-RP1