Principal Scientist, Medical Affairs - JJMT Neurovascular

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 bolthires of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more atJob Function:Medical Affairs GroupJob Sub Function:Medical AffairsJob Category:Scientific/TechnologyAll Job Posting Locations:Irvine, California, United States of AmericaJob Description:Johnson and Johnson is currently seeking a Principal Scientist, Medical Affairs, Neurovascular.This role is FullyRemote in the United States. 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 bolthires of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more atFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted inOur Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. We are looking for a highly motivated Principal Scientist to be part of Medical Affairs in Johnson & Johnson MedTech – Neurovascular. In this role, you will serve as the clinical, medical and scientific lead for clinical trials in the J&J MedTech Neurovascular portfolio. This role provides medical oversight, clinical direction and scientific expertise throughout study design, execution and reporting to ensure trial validity.The Principal Scientist, Medical Affairs collaborates closely with cross-functional teams to support successful trial delivery aligned with Johnson & Johnson’s clinical development strategy. Major Duties & Responsibilities• Serve as the primary study medical lead for company sponsored clinical studies• Support the clinical trial team to complete studies in a safe, effective, and timely manner. • Contribute towards development and approval of clinical trial protocols, informed consents, investigator brochures, committee charters, and other study materials• Conduct routine review of safety events, adverse events (AEs), medical coding, source documents, and subject narratives• Review and interpret clinical data, ensuring medical accuracy and consistency with the current medical literature.• Contribute to drafting and reviewing of study reports for assigned studies to include annual reports (APR), study close out reports (CSR) as well as other regulatory submissions• Attend Clinical Events Committee (CEC) and Data Monitoring Committee (DMC) meetings as required• Develop strong collaborative relationships with the study core team and other internal and external stakeholders to ensure study progress for assigned projects and that issues are identified and communicated to the next management levels• Provides informed clinical input during study team meetings• Support the generation of preclinical & clinical evidence strategies to support clinical claims and participate in characterizing the product's capabilities and clinical workflows in collaboration with Marketing, R&D, and other development team members.• Serves as the primary medical representative for product development projects (new products as well as lifecycle products). The main responsibilities include being the medical core team member on some product development project teams. • Provides expertise in technical dossier review for regulatory bodies (such as FDA or MDR) from a medical perspective for products in development and in lifecycle management. • Supports the medical and clinical operations teams by providing critical medical and scientific input to ensure product safety and efficacy.• Works with cross-functional partners in R&D, Clinical Research, Regulatory Affairs Biostatistics and Data Management and other departments on product development and pre- and post-approval clinical evidence activities. • Performs other duties assigned as needed. Requirements• Bachelor's degree is required. Advanced degrees such as Masters of Science, PhD, MD/DO are preferred. • Minimum 5 years of experience working in clinical, engineering, or life science fields, focusing on neuro-intervention preferred.• Extensive knowledge of neuro-interventional technology and techniques preferred. • Strong understanding of clinical research methodologies, regulatory guidelines, and medical terminology. • Proven track record to establish and maintain relationships with KOLs, interventionalists, and other healthcare professionals. • Ability to analyze and interpret scientific data quickly and accurately. • Excellent interpersonal, communication and presentation skills, with the ability to effectively communicate complex scientific concepts to both scientific and non-scientific audience.• Highly self-motivated, independent, and adaptable to changing priorities and environments. • Work authorization in USA• Excellent computer skills, especially with the use of bolthires Office• Travel Requirement: up to 20%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. Required Skills:Preferred Skills:Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Critical Thinking, Cross-Functional Collaboration, Healthcare Trends, Leverages Information, Medical Affairs, Medical Communications, Medical Compliance, Organizing, Product Strategies, Scientific Communications, Strategic Thinking, Tactical PlanningThe anticipated base pay range for this position is :$117,000 - $201,250Additional 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 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)). This position is eligible to participate in the Company’s 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 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.Apply tot his job