Job Properties
  • Job Type
    Full-time Position
  • Category
  • Languages
    English
  • Experience Required
    10+ Years
  • Degree Required
    Bachelor
    • Province
      5,423 reviews
    • Date Posted
      May 13,2021
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    NCC Compliance Specialist

    Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.

    Position Summary:

    The NCC Compliance Specialist is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.

    Principal Responsibilities:

    Quality Oversight Activities

    • Monitor compliance risk and ensure mitigation/remediation actions are defined
    • Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations and plan, prepare, conduct and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk-based activities:
    • Coordinate On-Site Quality Compliance Visits (if applicable)
    • Perform assigned reviews of Trial Master File, training compliance documentation and other checks per QP&S Integrated Quality Plan for the trial
    • Planning and execution of local QC checks
    • Support and advise local study teams in root cause analysis of significant observations
    • Ensure appropriate filing of the QC reports
    • Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals
    • Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed
    • Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support. Moderate level of risk awareness and ability to translate risks into actions.
    • Support the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents

    Local Onboarding and Consultation

    • Support onboarding of new hires
    • Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc
    • Provide advice regarding SOP, system and GCP questions of moderate complexity
    • Support managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk

    Local regulatory intelligence

    • Perform impact assessments of new/revised local regulations, guidance and standards
    • Support central functions in ensuring local intelligence is up to date

    Collaboration with Business Quality

    • Support LOC Management Review in collaboration with LOC Business Quality partners
    • Support local vendor assessments as appropriate
    • Support annual Due Diligence update, certification and training of local vendors, if applicable

    Principal Relationships:

    The NCC Compliance Specialist has a dual reporting line into the Director of the Non-Core Country Global Oversight Office and the NCC Compliance Leader, and is a member of the NCC Compliance Team and <regional> Compliance Team.



    Qualifications

    Education and Experience Requirements:

    Education:

    A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 4-6 years relevant experience equivalent is required. A minimum of 3 years of previous Pharmaceutical Industry experience is required, with at least 2 years of GxP experience within clinical research and development and/or quality assurance.

    Related Experience:

    • Knowledge of the overall drug development process
    • Developing or developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
    • Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
    • Ability to translate data into information and strategies into executable action plans improving the business
    • Ability to motivate professional colleagues and stakeholders
    • Conflict resolution/management and negotiation skills
    • Ability to independently plan, organize, coordinate, manage and execute assigned tasks
    • Experience of the key customers’ business processes and practices
    • Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;
    • Experience with regulatory submissions (NDA, BLA) is an asset

    General Skills:

    • Problem solver
    • Collaborator
    • Highly committed to quality
    • Flexible and persistent
    • Good conflict handling/negotiation skills
    • Able to create win-win situations with internal and external partners
    • Knowledge of the corporate structure and culture
    • Impact - Complexity and Scope - Contributes to the definition and development of new processes, standards or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results.
    • Typically has responsibility for smaller scope projects.
    • Manages limited number of projects, including some of moderate complexity. Leads smaller scope projects.
    • Contributes to local and regional strategy
    • Nature of Communication - Influences or persuades others within area of immediate responsibility, scope and level to accept new ideas, approaches and concepts.
    • Innovation:
    • Identifies issues; exercises judgment in developing new approaches/solutions and resolving issues within immediate area of responsibility and scope.

    Other Skills and Abilities:

    • Requires limited supervision. Possess good written, oral communication, interpersonal skills, diplomacy, and presentation skills and customer service.
    • Excellent knowledge of English is required
    • Proficient in Microsoft Office applications

    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
    Netherlands-South Holland-Leiden-
    Other Locations
    Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
    Organization
    Janssen Biologics (7266)
    Job Function
    R&D
    Requisition ID
    2105929150W
     
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