Reporting to the Manager, Regulatory Affairs, the Ethics and Regulatory Submissions Coordinator is responsible for preparing, submitting, and maintaining applications to the central ethics and clinical trial applications (CTA) to Health Canada. The Ethics and Regulatory Submissions Coordinator is also responsible of regulatory document preparation and or collecting and writing and or reviewing the informed consent forms.

This role will be perfect for you if:

• You have strong organizational and coordination skills.
• You want to work in a collaborative team where your ideas are heard and valued.

RESPONSIBILITIES

The Ethics and Regulatory Submissions Coordinator :

• Prepares, manages, and tracks central ethics and sites submissions; also responsible for submission to the Comité central d’éthique de la recherche (CCER).
• Acts as the primary point of contact for the central ethics committee.
• Prepares and submits Health Canada applications (e.g. CTA, CTA-A, CTA-N).
• Prepares regulatory forms (e.g. QIU, CTSI, FDA1572, FDF).
• Writes and/or reviews informed consent forms.
• Perform regulatory review of essential documents and authorizes shipment of investigational product to clinical sites.
• Manages translation requests with providers of translation services.
• May translate patient, advertisement materials and investigational product labels
• Reviews ethics and regulatory documents in the Trial Master File.
• Ensures submission and renewal timelines are met.
• Informs central ethics and the investigators when new safety information is available.
• May participates in study specific tasks as delegated by management.
• May act as the backup for the Regulatory Affair & Administrative Assistant Clinical Operations Admin (Site) 

PROFILE

Education 

• Bachelor of science;
• Specialized graduate diploma in drug development, regulatory affairs, is an asset;

Experience 

• Between 1 and 2 years of experience in ethics and/or regulatory submission;
• FDA IND submission experience, is an asset;
• Experience in regulatory CMC, is an asset

Knowledge and skills

• Knowledge of clinical research, ICH /GCP Guidelines, and applicable Health Canada and Food and Drug Administration (FDA) regulation/guidelines;
• Bilingual French and English (excellent oral and written) ;
• Excellent knowledge of Word and Excel;
• Ability to organize own work, prioritize different assignments, and work under pressure;
• Attention to detail and accuracy in work;
• Versatile and comfortable in a multitasking environment;
• Quick learner;
• Respect established timelines, expectations, priorities, and objectives.

The work environment 

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

In this position, you will be eligible for the following perks: 

• Flexible work schedule 
• Permanent full-time position 
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) ) 
• Ongoing learning and development 

About Innovaderm 

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

Innovaderm only accepts applicants who can legally work in Canada.