Country Approval Specialist at Thermo Fisher (Remote) | ₹6L-9L

Job Description

Join us as a Country Approval Associate and make an impact at the forefront of innovation. The Country Approval Associate supports the preparation, review, and coordination of Country Submissions in line with the global submission strategy.

What You'll Do

• Prepare, review, and coordinate local EC submissions under guidance, in alignment with the global submission strategy.
• Support the preparation of local MoH submissions, as applicable, under guidance and in alignment with the global submission strategy.
• Coordinate with internal functional departments to ensure site start-up activities are aligned with submission activities and mutually agreed timelines; ensure the submission process for sites and studies is aligned with the critical path for site activation.
• Achieve the company's target cycle times for sites.
• May have contact with investigators for submission-related activities.
• May act as a key contact at the country level for either Ethical or Regulatory submission-related activities.
• Work with the start-up CRA(s) to prepare regulatory compliance review packages, as applicable.
• Assist in developing country-specific Patient Information Sheet/Informed Consent form documents.
• Assist with grant budget(s) and payment schedule negotiations with sites.
• Enter and maintain trial status information relating to SIA activities onto company or client tracking databases in an accurate and timely manner.
• Ensure 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.