Johnson & Johnson MedTech is recruiting for a Staff Clinical Research Scientist located in Raritan, NJ or Cincinnati, OH. 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/. Overall Responsibilities On behalf of the MedTech Group, this clinical research professional will be responsible for the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects. Key Responsibilities: Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: + Acts as a highly trained individual contributor involved in the design, execution, and/or reporting of clinical trials and or studies. + Analyzes the results of clinical research projects and drafts reports with detailed outcomes and results for relevant groups. + Leverages documentation needed for data collection, analysis, reviews and maintaining correct standard operations, procedures, and protocol. + Develops expertise and understanding of clinical trials documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies, and process. + Coaches more junior colleagues in techniques, processes and responsibilities. + Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team. + Contribute 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) + Ensure 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 + Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal supervision + Plan 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 + Responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP) + Develop 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 + Draft 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 + Responsible for critically assessing the literature and drafting Clinical Evaluation Reports (CERs) for new products + Support 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 + Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, CSRs, and use of clinical data/evidence for market access and reimbursement + Foster strong relationships with key investigators to deliver evidence + Ensure registration on www.clinicaltrials.gov from study initiation through posting of results + Develop a strong understanding of the pipeline, product portfolio and business needs + Keep 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 **Qualifications** Education & Required Skills/Experience: + Bachelor’s Degree in Biological Science or related discipline with (6) years of relevant experience or a Master’s Degree in Biological Science or related discipline with (4) years of experience or a PhD in Biological Science or related discipline with (2) years of relevant experience Required Skills & Experience: + Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations + Ability to provide scientifically strategic and scientific clinical research input across NPD and LCM projects + Proven track record in delivering clinical projects within clinical/surgical research setting, on time, within budget and in compliance to SOPs and regulations + Ability to lead study teams to deliver critical milestones + Ability to collaborate across different functional areas within Clinical R&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.). and to meet business objectives + Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders + Leadership requirement – ability to influence, shape and lead without direct reporting authority Other: + This position can be based in Raritan, NJ or Cincinnati, OH and requires up to 10% travel, domestic and international travel. The anticipated base pay range for this position is [$125,500] to [$160,000] 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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement. For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits 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. \#LI-BD1