Staff Scientist, Clinical Development & Research

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/medtechJohnson & 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 regulations, policies, and procedures. Performs other duties assigned as needed.

Qualifications / Requirements: A Bachelor's or equivalent degree in Biological Science or related discipline. A minimum of 6 years related scientific / technical / clinical research experience. Background or experience in Biomaterials and/or Spine, preferred. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS Requires understanding of Good Clinical Practices Understanding and application of regulations and standards applied in clinical areas/regions is required Good presentation skills and effectively influencing of others Written and oral communication skills Demonstrated competencies in the following areas are required: Leadership in a professional and ethical manner Technical writing skills FUNCTIONAL AND TECHNICAL COMPETENCIES 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; Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. Performs other related duties as required. 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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Required Skills: Preferred Skills: Clinical Data Management, Clinical Evaluations, Coaching, Critical Thinking, Data Savvy, Drug Discovery Development, Ethical and Participant Safety Considerations, Good Clinical Practice (GCP), Industry Analysis, Medicines and Device Development and Regulation, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Technologically SavvyThe anticipated base pay range for this position is : $109,000.00 - $174,800.00 Additional Description for Pay Transparency: Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar yearfor employees who reside in the State of Colorado –48 hours per calendar yearfor employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52‐week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year