Job Description: Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Job Responsibilities: Deliver assigned clinical programs, through partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of project commitments (delivery on time, within budget and in compliance with regulations and SOP); Engage in 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; Partner internally to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement; Develop and deliver Global EGS / EDS to support NPD / LCM within the assigned device platforms, with collaborative relationships with all CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc.), ensuring alignment; Manages work independently; may provide solutions to complex situations. Develop relationships with external partners influence relevant policies; Lead team’s interaction and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory Agencies, societies, associations, etc.; Responsible for Clinical R&D activities for assigned projects, including: Lead team of clinical research scientists to design clinical trials to meet the NPD / LCM needs; Lead interpretation and dissemination of all evidence generated, based on EDS, including CSRs, CERs, abstracts, manuscripts, etc.; Ensure input and alignment from regional MD CR&D leads and strategically important countries/regions in the development of the EGS / EDS; Job Requirements: Leadership requirement – ability to influence, shape and lead without direct reporting authority; Proven track record in delivering clinical programs within clinical / surgical research setting in compliance to SOPs and regulations; Ability to collaborate across functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing results, etc.). and to meet business objectives; Ability to lead teams to deliver critical milestones; Change agent in team development and progression; Ability to manage scientists to provide strategic and scientific clinical research input across NPD and LCM projects; Proven track record forming relationships with internal and external partners; Qualification & Experience: Thorough understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, healthcare market environment including robotic and digital surgery, clinical trends, and global clinical trial regulations; A minimum of 1-2 year people management related experience is required for this role. A Bachelors or equivalent degree in Biological Science, Engineering, or related field. A minimum of 8 years related scientific / technical experience, including leadership / management role within Clinical Research. Job Details: Company: Johnson & Johnson Vacancy Type: Full Time Job Location: Harrisburg, PA, US Application Deadline: N/A Apply Here vacancyoptions.com
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