Staff Scientist, Clinical Development & Research

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 jnj.com 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: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – Non-MD Job Category: Scientific/Technology All Job Posting Locations: Raynham, Massachusetts, United States of America, Remote (US), Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America Job Description: About Orthopaedics 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 Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. We are searching for the best talent for Staff Scientist, Clinical Development & Research , located in Raynham, MA, West Chester, PA or Warsaw , Indiana. Remote work options may be considered on a case-by-case basis and if approved by the Company. This is a field-based role available in the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. Purpose: the Clinical research professional will be responsible for the development of clinical evidence generation (EGS) and evidence dissemination (EDS) strategies across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects. You will be responsible for : Under limited supervision, and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Contributes to the development and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access). Ensures input and strong alignment from key regional MD Clinical R&D leads and other strategically important countries/regions in the development of the EGS / EDS. Develops and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal supervision. Plans for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures. Is responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and Biostatistics and Data Management teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP). Develops strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders. Drafts study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions. Is responsible for critically assessing the literature and drafting Clinical Evaluation Reports (CERs) for new products. Supports clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections. Contributes to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, CSRs, and use of clinical data/evidence for market access and reimbursement. Fosters strong relationships with key investigators to deliver evidence. Ensures registration on www.clinicaltrials.gov from study initiation through posting of results. Develops a strong understanding of the pipeline, product portfolio and business needs. Keeps management informed of key developments and issues that impact clinical strategy and portfolio management. May be involved in other tasks to support clinical research activities as needed. Generally, manages work with limited supervision. Senior staff member may review work during development, dependent on level of complexity, and upon completion. Is responsible for communicating business related issues or opportunities to next management level. Is responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulation