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Associate Director Dossier Development and Operations Technical Integrator
Janssen Vaccines & Prevention B.V., previously Crucell, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture, and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
De functie / The role
In the Dossier Development and Operations Team, we are responsible for planning, writing, and reviewing the quality part of dossiers for vaccines of Janssen Vaccines & Prevention. You will join a team of regulatory technical writers reporting to the Director of CMC Dossier Development.
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.
Het profiel / Your profile
Education & Experience
We welcome applications from professionals with Ph.D. and Post-doc experience with 6+OR a university degree with 8+ years of significant experience.
You need also to understand Regulatory Affairs CMC in the EU and with FDA, experience in Regulatory Technical Writing, and excellent communication skills in a technical and regulatory environment.
The Team is looking forward to seeing your application.
Our company offers a broad range of benefits and a competitive salary.
Johnson & Johnson Family of Companies are equal opportunity employers, and 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.