Job Properties
  • Job Type
    Full-time Position
  • Background
    Biotech and Agricultural
    Management & Business Others
    Medical and Healthcare
  • Languages
    English
  • Experience Required
    6 - 10 Years
  • Degree Required
    Bachelor
    • Province
      5,376 reviews
    • Date Posted
      February 19,2021
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    Associate Director - Scientific Integrator (Dossier Development and Operations)

    The Associate Director, Dossier Development, is responsible, with limited guidance from the manager, for developing the technical eCTD sections to support Regulatory CMC dossier applications. With limited guidance from the manager, coordinates and provides technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. Coordinates the timeline, virtual document and the generation of the Quality module. Assumes personal ownership and accountability for business results and solutions working with limited supervision from the manager. Represents the department on multi-functional project development teams to support regulatory filings. Has expertise in appropriate CMC regulatory applications.


    Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations with limited guidance from the manager. The Associate Director supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as major applications with limited guidance from the manager. Evaluates and ensures the completeness, accuracy and compliance of data provided for all regulatory submissions with limited guidance from the manager. Ensures all Quality submissions are completed in a timely manner.

    Job Scope/Span of Influence


    • Contributes to dossier strategy/complex product development plan creation at a compound level and to limited degree at a functional level
    • Communicates and executes dossier strategy/product development plan with high level of autonomy and accountability
    • Direct responsibility for project budgets
    • Leads and supervises dossier authoring activities for early and late stage projects with limited or no guidance from manager
    • Identifies business improvement areas and leads implementation of improvements
    • Drives structured improvements of functional processes (quality, cost, time, asset utilization) in line with business or operational strategy.
    • With limited or no guidance, interfaces directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal DPDS customers such as GCO and TA
    • Interfaces with internal and external functional stakeholders
    • Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues with limited guidance and occasionally at multiple levels of management
    • Combines technical expertise with management skills. May select and manage external consultants
    • Manages several complex projects with potentially accelerated priority OR

    leads complex Phase 3 clinical programs

    • Challenges status quo and identifies innovative approaches to improve products/processes
    • Scope is a mix of incremental and transformational innovation, within own dept/team and function
    • Independently resolves isolated cross-functional issues
    • Appropriately identifies and manages key stakeholders and escalates when needed to obtain senior management support. With limited guidance, takes day-to-day decisions on operational priorities for his/her team, and allocates resources accordingly
    • Works independently on a day to day basis, checks in with supervisor as needed for identified high-priority issues
    • Manages functional or project teams with up to 15 members
    • Strong input on promotions, recruitment strategy and team structure
    • Acts as a mentor to one or more individuals
    • May coach project teams

    Qualifications
    • PhD with Post-doc experience with 6+ years relevant experience OR University degree with 8+ years relevant experience
    • Understanding of Regulatory Affairs in EU and with FDA
    • Experience in Regulatory Technical Writing
    • Excellent communication skills in a technical and regulatory environment

    Primary Location
    Netherlands-South Holland-Leiden-
    Organization
    Janssen Vaccines & Prevention BV (8852)
    Job Function
    R&D
    Requisition ID
    2105898087W
     
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