שימו לב, מודעה זו בת למעלה מ-40 ימים ויתכן שאינה אקטואלית
1
פונה
Regulatory Documentation Specialist
סוג משרה 
בחברת
CSJC Biocad
באיזור: עבודה בחול
Writing and editing of Quality documentation (biological/biosimilar/pharma), in accordance with the company’s SOP and Regulatory Authorities requirements.
Preparation of DMF in collaboration with members of project team.
Reviewing and editing technical and scientific protocols, reports and dossiers to ensure regulatory compliance.
Responding to questions and comments from Regulatory Authorities.
Maintaining document design consistency for all documents to ensure compliance with company document design standards including the use of predetermined templates.
Requirements
Minimum of a Bachelor’s degree in
Biotechnology/Biochemistry/Chemistry/Pharmacy Sciences.
Excellent verbal and written communication skills in English and Russian.
Working knowledge of scientific and analytical terminology.
Experience in analytical/bioanalytical/R&D laboratory, knowledge of analytical methods of analysis, –advantage.
Experience with regulatory processes and standards – advantage.
Other requirements: organization skills, accuracy and attention to details, ability to work on multiple projects simultaneously and set priorities, open-minded, problem solvent attitude, computer skills (MS Office is required).
Relocation to Moscow, Russia
Preparation of DMF in collaboration with members of project team.
Reviewing and editing technical and scientific protocols, reports and dossiers to ensure regulatory compliance.
Responding to questions and comments from Regulatory Authorities.
Maintaining document design consistency for all documents to ensure compliance with company document design standards including the use of predetermined templates.
Requirements
Minimum of a Bachelor’s degree in
Biotechnology/Biochemistry/Chemistry/Pharmacy Sciences.
Excellent verbal and written communication skills in English and Russian.
Working knowledge of scientific and analytical terminology.
Experience in analytical/bioanalytical/R&D laboratory, knowledge of analytical methods of analysis, –advantage.
Experience with regulatory processes and standards – advantage.
Other requirements: organization skills, accuracy and attention to details, ability to work on multiple projects simultaneously and set priorities, open-minded, problem solvent attitude, computer skills (MS Office is required).
Relocation to Moscow, Russia
פורסם ב 25-07-2011
נצפה: 240 פעמים
נצפה: 240 פעמים