Regulatory Affairs Specialist - Gatineau, Canada - The Memory Clinic
Description
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.
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 startup 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
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Accountable
- Is accountable for their actions
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Adaptability
- Can adapt to change, is flexible and can work in a fast paced environment
Commitment to Excellence
- Proven commitment to quality and excellence
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Compassion
- Shows compassion and patience towards others
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Communication
- Excellent communication skills in French and English
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Decision Making
- Has good judgement and decision making skills
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Innovation
- Is innovative and looks for ways to improve
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Integrity
- Has Integrity, is ethical and professional
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Teamwork
- Positively interacts with others and promotes team work
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Patient Focused
- Has the patient needs in mind and is committed to the industry
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