Johnson & Johnson Careers
Lead Associate, Submission Management
Requisition ID: 1805659326W
LEAD ASSOCIATE: SUBMISSION MANAGEMENT
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 therapeutic area team within Regulatory Submissions Management and Operations.
We discover and develop innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
We are looking for a Submissions Management Associate to lead and deliver regulatory submissions to global health authorities, while supporting and developing the registration of new products, Primarily Clinical Trial Applications (CTA’s). You will be establishing dossier plans for the assigned submissions that reflect inputs from the internal and external partners. Through regular meetings with these partners you will identify and resolve issues, assess quality and Dossier Plans to be delivered within timeline of the established metrics.
- Ensuring conformity to Reginal and Country specific requirements are applied to all relevant processes, including Electronic components, dossier level publishing and production of regulatory submissions
- Monitoring the effectiveness of appropriate submission processes with responsibility for initiating changes within 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 appropriately.
- Develop/maintain associated process tools and relevant training documentation.
- Support compliance needs as appropriate.
- 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 to ensure dossier components conform to submission standards.
- Apply appropriate regulatory submission standards, requirements, processes and policies to align with regulatory 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.
- Regulatory Affairs experience
- A Bachelor’s Degree in Sciences or equivalent
- Understanding of drug development process
- Therapeutic area and product knowledge
- Proven project or submission management capabilities
- Effective interpersonal, teamwork, and communication skills
- Problem solving capability, including trouble shooting and flexibility
- Proven ability to build positive relationships across an organization
- Knowledge of submission-related Health Authority and Industry regulations and guideline.
- Experience within managing or publishing of global regulatory submissions, Preferably CTA’s
Are you located in Europe or USA ? This is a global role that can be performed in the following locations:
Europe: Beerse, Belgium; Leiden, The Netherlands; High Wycombe, England
USA: Raritan / Titusville, NJ; Spring House/ Horsham / Radnor / Malvern PA.; La Jolla / San Francisco / Los Angeles, CA.
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Johnson & Johnson Family of Companies are equal opportunity employers, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)