Abogado/A Para Tribunal De Familia – Prm Independencia

Ciudaddelnino; Santiago; On-site; CLP 12,000,000 - 18,000,000; Full time

Job summary

Thermo Fisher Scientific in Santiago seeks a Country Approval Associate to support preparation, review and coordination of country submissions within the global strategy. You will assist with MoH submissions and coordinate with internal teams to ensure timelines align with site activation.

Responsibilities include preparing regulatory review packages, assisting with patient information materials, budgets and tracking trial status, while maintaining SOPs and regulatory knowledge.

Qualifications

• Bachelor’s degree or equivalent plus formal academic qualifications.
• 0–2 years experience in regulatory submissions or related field.
• Equivalency may be considered with education, training and related experience.
• Strong communication and organizational skills are required.

Responsibilities

• Prepare, review and coordinate country submissions per global strategy.
• Support local MoH submissions as applicable, aligning with strategy.
• Coordinate with internal departments to align site start-up with submissions.
• Help achieve target cycle times for site activation.
• May contact investigators for submission-related activities.
• May act as country-level contact for ethical or regulatory submissions.
• Assist in compiling regulatory review packages with start-up CRA(s).
• Assist with country-specific Patient Information Sheet/Consent forms.
• Assist with grant budgets and site payment schedules.
• Update trial status in tracking databases accurately.
• Maintain local study files per SOPs and ensure filing readiness.
• Maintain knowledge of SOPs, directives and regulatory guidelines.

Skills

Effective oral and written comms

Excellent interpersonal skills

Strong attention to detail

Good negotiation skills

Good computer skills

Good English language skills

Medical terminology knowledge

Teamwork or independent work

Organizational and planning skills

Regulatory guidelines knowledge

Education

Bachelor's degree or equivalent

Relevant formal academic or vocational qualification

Job description

FSP Country Approval Associate

Santiago ThermoFisher Scientific

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.