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Bilingual Regulatory Affairs Specialist

3 weeks ago

Ottawa, Ontario, Canada The Memory Clinic Full time

SUMMARY

Our company is seeking a Regulatory Affairs Specialist who supports the Regulatory Affairs team by ensuring that the clinical studies comply with regulations established by stakeholders.

This position is also responsible for executing all regulatory submissions to ensure compliance.

RESPONSIBILITIES

  • Ensures clinical study regulations are adhered to as established and enforced by the pharmaceutical companies, regulatory authorities, ethics review boards, and other stakeholders

  • Initiates and oversee the start-up phase and activities for studies

  • Coordinates all IRB submissions to ensure regulatory compliance

  • Updates all manuals and protocols as required

  • Leads all communication with the sponsors and Clinical Research Organizations (CRO)

  • Keeps up to date on all regulatory matters

  • Performs work in accordance with the provisions of the Occupational Health and Safety Act and Regulations and all company policies and procedures related to Occupational Health and Safety.

Performs other related duties as assigned.

EDUCATION AND QUALIFICATIONS

  • Bilingual in English and French (Essential)

  • A Post-Secondary Degree or Diploma in health, law, science or management, or a combination of education, training and experience deemed equivalent

  • A minimum of two (2) years of experience in medical or research work environment

  • Able to commute to both locations (Ottawa and Gatineau)

  • Knowledge of Microsoft Office Suite and other software tools

CORE COMPETENCIES

  • Accountable - Is accountable for their actions

  • Adaptability - Can adapt to change, is flexible and can work in a fast paced environment

  • Commitment to Excellence - Proven commitment to quality and excellence

  • Compassion - Shows compassion and patience towards others

  • Communication - Excellent communication skills in French and English

  • Decision Making - Has good judgement and decision making skills

  • Innovation - Is innovative and looks for ways to improve

  • Integrity - Has Integrity, is ethical and professional

  • Teamwork - Positively interacts with others and promotes team work

  • Patient Focused - Has the patient needs in mind and is committed to the industry