Dossier Development Technical Integrator

Job description

Janssen Vaccines, 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.

In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team, we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.

For our department, we are currently seeking for a fulltime

Dossier Development & Operations Technical Integrator (m/f)

The Dossier Development & Operations Technical Integrator, VPAD is responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. Coordinates and provides technical oversight for the generation of the CMC dossier of clinical trial submissions. Coordinates the timeline, virtual document, and generation of the Quality module. Assumes personal ownership and accountability for business results and solutions, working with managerial supervision. Represents the department on multi-functional project development teams to support regulatory filings.

Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations. The Dossier Development & Operations Technical Integrator supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as assists the team lead in preparing responses to marketing. Evaluates and ensures the completeness, accuracy, and compliance of data provided for all regulatory submissions. Ensures all Quality submissions are completed in a timely manner.

Desired profile

·  A minimum of a Bachelor's degree in Chemistry, Pharmacy or related science is required
·  A Master's or PhD in Chemistry/Pharmacy or related science is preferred
·  A minimum of 2 years pharmaceutical industry experience is preferred
·  Vaccine experience is a plus
·  Experience in CMC dossier preparation is required
·  Excellent verbal and written communication skills are required
·  Excellent skills in computer applications including Word, PowerPoint and Excel are required
·  Must be able to navigate ambiguous situations and provide consistent support for the CMC technical functions contributing to the Quality submissions
Competences:

·  Ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required
·  Excellent written, verbal communication and presentation skills are required.
·  Ability to communicate clearly, succinctly and effectively over the phone and in writing is required.
·  Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required.
·  Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.
·  Ability to manage and external contractors is required
·  Ability to coach and develop departmental scientists in technical writing



What's in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.