Senior Director/Director Clinical Development
. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission...
. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission...
to multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossier Review... on CMC sections of submission dossier Support the development of processes and to the preparation of Standard Operating...
an electronic dossier (no paper submissions please) including a cover letter, areas of teaching interest, a curriculum vitae, a list...
regulatory strategy plans, from development and throughout the life-cycle of the dossier/product with the focus on nonclinical...
, regulation monitoring, dossier preparation, submissions, renewals, and compliance support. The ideal candidate...
, documenting the humanistic burden of disease, utility elicitation, patient preference studies and global value dossier development...
, patient preference studies and global value dossier development Mastery of technical skills in at least some of the following...
into Dossier, Republic Services Fleet Management Software system. Collects and interprets analyses from oil sampling, on-board...
;participates with the team to achieve safety goals Reconciles Dossier financial data to Lawson general ledger. Supports the Fleet...
in Republic Services Dossier (Fleet Management Software) system. Perform preventative maintenance according to standard schedules...