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Staff Scientist, Clinical Development & Research at Johnson & Johnson
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Home›Jobs›IT & Software›Staff Scientist, Clinical Development & Research
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Staff Scientist, Clinical Development & Research

Johnson & Johnson

RemoteFull timeMid level$109k – $175kPosted today
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About the role

About This Role

Supporting the development and delivery of clinical evidence generation and dissemination strategies across assigned New Product Development and Life-Cycle Management projects is the core of this role for a clinical research professional. This position contributes to reimagining how orthopaedics heal by building solutions for various joint, trauma, and surgical needs.

Responsibilities

  • Contribute to the development and delivery of appropriate Global Evidence Generation Strategy (EGS) / Evidence Dissemination Strategy (EDS) to support New Product Development (NPD) and Life-Cycle Management (LCM) within 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 to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures
  • Deliver assigned clinical programs through effective partnership with the Clinical Operations and Biostatistics and Data Management teams
  • 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, including annual reports, study close-out reports, and clinical sections for IDE, PMA, 510(k), and other regulatory submissions
  • Critically assess the literature and draft 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
  • 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
  • Be involved in other tasks to support clinical research activities as needed
  • Manage work with limited supervision; senior staff member may review work during development and upon completion
  • Communicate business related issues or opportunities to next management level

Job details

Workplace

Remote

Employment

Full time

Seniority

Mid level

Headquarters

Raynham, Massachusetts, United States of America

Salary

$109k – $175k

Posted

Posted today

About company

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  • Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures
  • Perform other duties assigned as needed

    • Requirements

    • Bachelor’s or equivalent degree in Biological Science or related discipline
    • Minimum of 6 years related scientific / technical / clinical research experience
    • Understanding of Good Clinical Practices
    • Understanding and application of regulations and standards applied in clinical areas/regions
    • Good presentation skills and effectively influencing others
    • Written and oral communication skills
    • Demonstrated competencies in leadership in a professional and ethical manner
    • Technical writing skills
    • 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 and to meet business objectives
    • Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders
    • 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 compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer

    Nice to have:

    • Background or experience in Biomaterials and/or Spine

    Benefits

    • Vacation – 120 hours per calendar year
    • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for 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 period (10 days)
    • Volunteer Leave – 32 hours per calendar year
    • Military Spouse Time-Off – 80 hours per calendar year

    Important Details

    • Work locations: Raynham, MA; West Chester, PA; Warsaw, IN
    • Work format: Remote work options may be considered on a case-by-case basis and if approved by the Company

    About the Company

    Johnson & Johnson is a healthcare innovation company focused on preventing, treating, and curing complex diseases, and delivering smarter, less invasive, and personal solutions. Through its expertise in Innovative Medicine and MedTech, it innovates across the full spectrum of healthcare solutions. Johnson & Johnson announced plans to separate its 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, regulatory approvals, and other customary conditions and approvals.

    At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going.

    Headquarters

    Raynham, Massachusetts, United States of America

    Open jobs

    3069

    Website

    jnj.com
    Johnson & Johnson logoJohnson & Johnson