Job Title: Country Approval Associate
Job Location: Remote, Canada
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Country Approval Associate - Make an Impact at the Forefront of Innovation The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with global submission strategy.
What You'll Do:
Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy.
Support preparation, under guidance, of local MoH submissions, as applicable in
alignment with global submission strategy.
Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieve company’s target cycle times for site.
May have contact with investigators for submission related activities.
May act as a key-contact at country level for either Ethical or Regulatory submission-related activities.
Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
Assist in developing country specific Patient Information Sheet/Informed Consent form documents.
Assist with grant budgets(s) and payment schedules negotiations with sites.
Enter and maintain trial status information relating to SIA activities onto company, or client (where contracted) tracking databases in an accurate and timely manner
Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Education & Experience Requirements:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:
Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic organizational and planning skills
Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations.
Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear, garments and gloves.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Lifelancer is a SaaS-based platform that connects freelance experts and remote job seekers with employers in the Life Science, Pharma, Biotech, Healthcare, Digital Health, and IT sectors. The platform enables talent hiring and job placement across domains including Bioinformatics, Data Science, and Medical fields, serving startups, SMEs, and established employers globally. Lifelancer addresses the growing demand for remote and freelance work in life science sectors, empowering both independent consultants and organizations to connect across borders. The company's DIY online platform facilitates talent-hiring, remote job opportunities, and freelance consulting services tailored to the life science and digital health industries.
