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J&J Family of Companies Staff Clinical Research Scientist in Warsaw, Indiana

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, is recruiting for a Staff Clinical Research Scientist. This position is ideally based in Warsaw, IN or Leeds, UK however remote candidates may be considered.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

On behalf of the DePuy Synthes Joint Reconstruction Franchise, 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 throughout Product Life-Cycle Management (LCM) projects.

Key Responsibilities:

  • Responsible for critically assessing the literature in support of leading the project team (collaboration: R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access) to develop and deliver the appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms.

  • 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 and Contracting Resource to lead 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 clinical study project 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 direction 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.

  • 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, reimbursement and post market surveillance reports;

  • 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.

    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;

  • Consistent 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;

    Leadership Competencies:

  • Foster strategic partnerships with key internal & external partners to ensure development and timely delivery of innovative EGS / EDS

  • Build strong relationships with external stakeholders

  • Lead critical scientific thinking to develop innovative EGS

  • Ensure clinical projects are delivered on time, within budget and in compliance to regulations and SOPs

  • 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.

Qualifications

  • A minimum of a Bachelor’s or equivalent degree with a minimum of 6 years of related scientific / technical / clinical research experience in Biological Science

    OR

  • A minimum of a Master’s degree or higher with a minimum of 4 years related scientific / technical / clinical research experience in Biological Science

  • A minimum of 3 years clinical research experience is required

    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.

Primary Location

United States-Indiana-Warsaw-700 Orthopaedic Drive

Other Locations

North America-United States, Europe/Middle East/Africa-United Kingdom-England-Leeds

Organization

Medical Device Business Services, Inc (6029)

Job Function

R&D

Requisition ID

2105921863W

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