Dossier Development & Operations Technical Integrator; (Senior)Scientist/Associate Director (1 of 2 Job in Antwerpen 2340, Antwerp Belgium
Janssen Pharmaceutica behoort samen met de andere bedrijven op onze campus tot de wereldwijde groep Janssen, die deel uitmaakt van de Johnson Johnson-groep. We ontwikkelen geneesmiddelen voor patiënten, artsen en andere zorgverstrekkers.
Dossier Development Operations Technical Integrator; (Senior)Scientist/Associate Director (1 of 2
The Scientist - Regulatory CMC Dossier manages the development of Quality related CTD sections (Module 3) with supervision from senior staff. Coordinates and provides technical oversight for the generation of the CMC dossier (module 3) of marketing and clinical trial submissions with close supervision of senior staff. Coordinates the timeline, virtual document and the generation of the Quality module. Assumes personal ownership and accountability for business results and solutions working with supervision from senior staff. Represents the department on multi-functional project development teams to support regulatory filings.
The Scientist - Regulatory CMC Dossier supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as major applications. 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.
The Scientist - Regulatory CMC Dossier continues to develop a knowledge of regulatory guidances. Provides interpretation with some guidance from senior staff of relevant CMC guidances (ICH, FDA, EMA, etc) and provides prompt regulatory risk assessments and recommendations.
A minimum of a Bachelor's degree in Chemistry, Biology or related science is required. A Master's or PhD in Chemistry/Biology or related science is preferred. A minimum of 6 years pharmaceutical industry experience is required. Large molecule experience preferred. Experience in CMC dossier preparation and filings is preferred. Technical background in chemistry or pharmaceutics is required.
The selected candidate must consistently develop clear and unambiguous direction and structure for the CMC team, influence project decisions, sizes opportunities in project and within CMC organization to influence direction and decisions. 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. Must possess exceptional interpersonal skills in order to help manage technical reports authored by the functions for submission in regulatory applications.
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