Careers

The organizational culture at Ozmosis Research can be described as an achievement culture
We value, openness, honesty, and transparency
Process improvements and thinking innovatively are key to the success of the organization

Ozmosis Research is an equal opportunity employer.

We welcome you to send your resume to ozmcareers@ozmosisresearch.ca. Please include a cover letter outlining relevant work experience, professional skills, and the position you seek.

We appreciate your interest, however, only candidates selected for an interview will be contacted.

Current Postings

JOB SUMMARY

The Quality Assurance & Regulatory Affairs Specialist (QARAS) provides support to the Senior Director of Quality Assurance & Regulatory Affairs (SDQARA) and Ozmosis team in quality control/quality assurance and regulatory affairs.

QUALIFICATIONS

  • At minimum, completion of a Bachelor’s of Science degree or recognized equivalent
  • Experience in some or all of Oncology, Clinical Trials, Good Clinical Practice, Quality Control/Assurance, Regulatory Affairs involving human subjects, preferred
  • Experience in CTA including Preparation of Module 2, IND, ITA submissions preferred
  • Good written and verbal communication skills, excellent organization, prioritization skills, excellent computer skills and the ability to learn quickly
  • Ability to work under pressure and attention to detail
  • Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to Ozmosis Research Inc. standards
  • Possess good critical thinking skills with the ability to multi-task
  • Ability to work well as part of a team
  • Relevant knowledge of Health Canada and FDA regulations relating to Clinical Trials

KEY ACCOUNTABILITIES & RESPONSIBILITIES

  • Prepare and submit regulatory submissions (ex: CTA, CTA-A, CTA-N) to Health Canada and FDA according to regulatory requirements
  • Liaise with regulatory authorities and internally to ensure that any requests for clarifications are responded to within the required timelines
  • Assist with preparation for any regulatory meetings (ex: pre-CTA meetings)
  • Perform quality control reviews and audits, communicate results to staff, SDQARA, other members of Senior Management and oversee all reports through to resolution
  • Support the development and maintenance of tools, trackers, and documents relating to Regulatory Affairs, QC/QA including but not limited to the Master CAPA logs, SOP deviation logs, Internal Audit Tracking, etc.
  • Support the maintenance of the eTMF index, plans, guidelines and other templates and coordinate eTMF issues between internal staff and vendor
  • Responsible for the maintenance of SOP revisions, approvals and other documentation
  • Responsible for the maintenance of Document Control documents and process
  • Responsible for the maintenance of training documents, organizing training sessions for Ozmosis staff and assist with training on QA and Regulatory topics.
  • Provide assistance to the SDQARA with metrics analysis, internal audits, preparation of external audits, vendor audits, site audits and writing of audit reports
  • Contributing to applicable Ozmosis SOPs, documents, and guidelines

Other accountabilities and responsibilities may be required depending on business needs.

Ozmosis Research Inc. provides benefits, a generous pension plan and competitive salary that commensurate with experience and skills. Thank you to all applicants for your interest. Only selected applicants will be contacted.

Training Standards

Minimum Bachelor’s Degree in Science with post-grad Clinical Research Training or experience

Continuous Training including:

  • GCP Training every 2 years
  • Ethics & Privacy Training: TCPS2
  • Disease Site Oncology Training
  • Regulatory Updates
  • SOP Training
  • Others as needed (Response criteria, correlatives, etc)