Country Approval Associate

Thermo Fisher Scientific • Toronto, ON

4d • Onsite

About The Position

The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with global submission strategy.

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).
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Thermo Fisher Scientific values passion, innovation, and a commitment to scientific excellence.
• Work in an environment where collaboration and development are part of the everyday experience.
• Contributions truly make a difference.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level