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Regulatory Affairs Assistant

July 20 2017
Industries Pharmaceutical, Biotechnology
Categories Administrative Support, Clinical research, Scientific and Regulatory affairs
Montreal, QC

Innovaderm is currently looking for a Regulatory Affairs assistant.

 

Your responsibilities

 

·         Prepare, manage and follow up on submissions to the Ethics Committee for the site;

 

·         Is the primary point of contact for ethics committees; receives and processes communications / approvals.

·         Complete and track the signatures of regulatory forms (ex: QIU, FDA1572, FDF);

·         Follow up on approvals and translation of consent forms;

·         Maintain regulatory record of studies;

·         Ensures tracking of submission and renewal schedules and ensures they are met;

·         Prepare and update the various documents necessary for the construction of the files of the persons involved in a research project (eg CV, attestation of training, etc.)

·         Hold and update the investigator's binders;

·         Responsible for the closure and annual renewal of ethics projects;

·         Assist the Research Coordinator in communicating with the Sponsor and performing clerical duties;

·         Participate in project-specific tasks as delegated by managers

 

Requirements

  • College Degree (DEC) ;
  • Minimum 5 years of experience in clinical research or pharmaceutical / medical devices industry;
  • Minimum 1 year of experience in Quality Assurance, clinical research or regulatory affairs;
  • Excellent knowledge of the Microsoft Office suite (Word, Excel and PowerPoint);
  • Bilingual: French and English, written and spoken;
  • Detailed oriented, autonomous and rigorous;
  • Strong ability to manage and prioritize different assignments, work under pressure and meet timelines. 

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