HireDiversity

Beerse, BE

Dossier Development & Operations Technical Integrator; (Senior)Scientist/Associate Director-00000A00

Omschrijving

The Dossier Development & Operations (DDO) group within Janssen Research & Development is responsible for the authoring of all CMC dossiers for new chemical and biological entities. A DDO Technical Integrator is typically responsible for the CMC dossier authoring of two to three new compounds. The Technical Integrator follow these compounds, while being a member of the CMC development teams, through the clinical phases to the final marketing applications in the US, EU, Japan, and other important markets.

As a member of the CMC development team the DDO Technical Integrator coordinates and provides technical oversight for the preparation of the CMC dossier (module 3) of marketing and clinical trial applications. Coordinates the timeline, builds the granular structure and oversees the content of the Quality module. Assumes personal ownership and accountability for business results and solutions. Represents the department on multi-functional project development teams to support regulatory filings.

The Technical Integrator can be seen as a project manager for the CMC dossier. In collaboration with the CMC technical functions, he/she prepares responses to health authority questions in support of clinical trial and marketing applications. Evaluates and ensures the completeness, consistency and compliance of data provided for inclusion into CMC regulatory submissions and ensures timely preparation of these. The Technical Integrator develops an in-depth knowledge of regulatory guidances, and keeps track of new regulatory guidances & trends relevant to CMC development. Provides interpretation of relevant CMC guidances (ICH, FDA, EMA, etc) and provides prompt regulatory risk assessments and recommendations.

Kwalificaties
- 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 6 years pharmaceutical industry experience is preferred
- Large molecule experience is a plus
- Experience in CMC dossier preparation is a plus
- Excellent verbal and written communication skills are required
- Excellent skills in computer applications including Word 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

Primaire locatie: Europa/Midden-Oosten/Afrika-België-Antwerpen-Beerse

Organisatie: Janssen Pharmaceutica N.V. (7555)

Functie: Regulatory Affairs