Algortihme Pharma Documentation specialist Internship in Montréal, QC

Overview

Algortihme Pharma

Branch Montréal QC CA

Position:
Documentation specialist
Location:
Montréal, QC

In general the scope of this role is limited to Clinical SOPs, Training documentation, Source document templates, supportive QMS documentation….

The Documentation Specialist is responsible for ensuring that controlled documents are harmonized, and written according to regulatory and user requirements. In general the scope of this role is limited to Clinical SOPs, Training documentation, Source document templates, supportive QMS documentation. – To ensure newly proposed internal procedures and SOPs are in accordance with current regulatory guidelines; – Ensures that document reviews are performed within acceptable timeframes; – Ensures feedback is obtained from all relevant stakeholders prior to finalizing documentation; – May be a member of the Clinical Compliance Team; – To write and review clinical SOPs, and related training material , ensuring that any associated source data is developed and appropriately maintained; – To promote quality initiatives to improve documentation quality in the clinic; – To conduct all work in compliance with SOPs, GCPs, GxPs and observe all company guidelines and policies; – To assist in responding to client pre-site audit questionnaires and to site audit reports; – To review regulatory literature regularly to ensure clinical procedures are in compliance; – To execute other duties as directed or assigned. Requirements: DEC or Bachelor degree or equivalent experience related to position.

Two (2) to three (3) years of experience in a clinical research setting an asset. Technical writting experience an asset, advanced knowledge of GCP, GMP, SOPs and TPD/FDA guidelines. Skills: Good organization skills, well-developed time management skills, excellent English communication skills (spoken and written), good interpersonal and strong leadership skills. Software: Outlook, MS-Office.

The offer: full time position with complete benefits plan.