Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Lead Associate, Submission Management with Clinical Trial Application management experience to be part of the Oncology or Cardiovascular therapeutic area teams within Regulatory Submissions Management and Operations. This position may be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Radnor, PA; Malvern, PA, La Jolla, CA; San Francisco, CA; Los Angeles, CA; Beerse, Belgium; Leiden, The Netherlands; or High Wycombe, England.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Lead Associate, Submission Management will:
• Be responsible for the management and delivery of regulatory submissions to global health authorities required to support the development and registration of products, primarily focused on EU and other ex-US Clinical Trial Applications (CTAs).
• Establishing Dossier Plans for the assigned submission types that reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
• Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
• Monitoring the effectiveness of appropriate submission processes with responsibility for initiating changes within the scope of decision-making authority to minimize inefficiencies and ensure quality.
• Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
• Support development of departmental work practices, process enhancements, and associated training materials.
• Represent department on Janssen initiatives where appropriate.
• Develop/maintain associated process tools and relevant training documentation.
• Support compliance needs as appropriate.
May also have responsibility to:
• Determine the scope of the electronic publishing requirements for the dossier.
• Utilize current electronic document management and publishing technologies to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions with a high degree of independence.
• Provide component-level publishing support for Regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.).
• Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirement.
• QC electronic and paper submissions to ensure compliance with company and applicable health agency requirements.
• Maintain open, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission.
• Participate on special projects and process improvement initiatives, as needed.
• A minimum of a Bachelor’s Degree or equivalent degree required
• A minimum of 6 years of relevant/related professional experience required
• A minimum of 3 years of Regulatory Affairs experience required
• Experience associated with managing or publishing of global regulatory submissions, in particular CTA’s, is highly preferred
• Oncology/Cardiovascular therapeutic area and product knowledge is preferred
• Understanding of drug development process required
• Demonstrated project or submission management capabilities is highly preferred
• Demonstrated effective interpersonal, teamwork, and communication skills required
• Ability to exercise solid judgment and communicate effectively with varied levels of the organization required
• Ability to work or lead in a matrix environment required
• Demonstrated ability to build productive relationships across an organization required
• Knowledge of relevant submission-related Health Authority and Industry regulations and guidelines is required
• Problem solving capability, including trouble shooting and adaptability required
• Ability to use Regulatory Information systems required
• This role will be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Radnor, PA; Malvern, PA, La Jolla, CA; San Francisco, CA; Los Angeles, CA; Beerse, Belgium; Leiden, The Netherlands; or High Wycombe, England and may require up to 5% travel, domestic and international.
United States-New Jersey-Raritan
North America-United States-California-Los Angeles, North America-United States-Pennsylvania-Radnor, North America-United States-Pennsylvania-Malvern, North America-United States-Pennsylvania-Horsham, North America-United States-California-San Francisco, North America-United States-California-La Jolla, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC. (6084)
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