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
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Clinical Development & Research Non-MDJob Category:
Scientific/TechnologyAll Job Posting Locations:
Irvine California United States of AmericaJob Description:
Johnson and Johnson is currently seeking a Senior Clinical Research Scientist to support the external research and evidence generation strategy needs of the Electrophysiology business. This role is based in Irvine CA and reports to the office on assigned days 2-3 times per week.
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 Senior Clinical Research Scientist will join the Clinical Science & External Research (CSER) Team responsible for global evidence dissemination of scientific findings from investigator led clinical trials and registries sponsored by Johnson & Johnson MedTech Electrophysiology. This associate will play a critical role in the creation and delivery of accurate high-quality scientific content that communicates clinical and real-world data on the Companys Electrophysiology medical devices. This role is responsible for contributing scientific content in study design execution and data interpretation in partnership with external collaborators while supporting evidence generation strategy. The ideal candidate will have strong scientific writing experience deep familiarity with the cardiovascular and/or electrophysiology clinical landscapes and a thorough understanding of clinical trials regulatory guidelines and clinical study design.
Key Responsibilities:
Produce clinical study protocols and clinical study reports ensuring scientific soundness and compliance with regulatory requirements
Conducts literature & landscape reviews to identify concepts of importance to patients to inform evidence strategy
Support and coordinate multiple real-world evidence research studies in partnership with external groups: participating study site staff Clinical Research Organizations (CRO) and vendors and with internal teams: medical affairs data management biostatistics data programmers and regulatory affairs
Ensure clinical research studies follow regulatory standards and maintain accurate detailed documentation for audits and submissions
Develop and deliver high-quality scientific manuscripts abstracts posters and podium presentations for publication in peer-reviewed journals and presentation at major cardiovascular and Electrophysiology congresses
Collaborate closely with internal cross-functional teams (Clinical Biostatistics Medical Affairs Global Strategic Marketing Health Economics and Market Access) and external physician authors to ensure accuracy alignment and scientific integrity
Analyze and interpret clinical data; effectively communicate data using well-structured tables and visually compelling figures
Support the strategic evidence planning for key products and studies including first-in-human trials pivotal studies indication expansions post-market surveillances and registries
Engage with Clinical Science & External Research associates and cross-functional teams to develop evidence strategy
Adhere to external guidelines and Company policies governing the ethical development of clinical data publications while continuing to look at innovation in publication and scientific communications
Maintain awareness of emerging trends and competitors in cardiovascular and electrophysiology therapy spaces to inform content development
Stays on top of current scientific data by participating in monthly literature review and sharing key insights with global teams
Qualifications
Required:
Minimum of a bachelors degree in Life Sciences Physical Science Nursing Biological Science or closely related field
Minimum of 2 years of direct involvement in clinical research trials and scientific publications in a medical device industry or related setting in cardiovascular therapeutic area
Excellent written and oral communication skills
Strong project management skills to balance multiple projects
Excellent interpersonal skills with the ability to build relationships and collaborate effectively with key partners across different time zones
Demonstrated adaptability in fast-paced evolving environments
Knowledge of Good Clinical Practices Evidence Generation Strategy and ICMJE standards
Preferred:
PhD/MD/PharmD with industry/academic research experience
Experience in clinical study management within electrophysiology therapeutic area
Experience interacting with external investigators
ISMPP CMPP or AMWA MWC credentials
Knowledge of electrophysiology procedures and terminology
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 . Internal employees contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$89000 - $143750Additional Description for Pay Transparency:
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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys 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. Experience:Senior IC
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more