FSP Country Approval Specialist

ThermoFisher Scientific; Argentina; A distancia; ARS 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Country Approval Specialist to manage and coordinate local regulatory submissions in line with global strategy. You will liaise with MoH/EC, provide regulatory guidance, and ensure timely alignment of site activation with submission timelines.

Ideal candidates have a Bachelor's degree and 2+ years of related experience, strong communication skills, and knowledge of regional regulatory guidelines. Office-based role in Argentina with standard Mon-Fri hours.

Formación

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 2+ years of related experience or knowledge to perform the job.

Responsabilidades

• Prepares, reviews and coordinates local regulatory submissions (MoH, EC, etc.) in line with global strategy.
• Provide local regulatory strategy advice to internal clients.
• Coordinate country submissions and SIA services.
• May interact with investigators for submission activities.
• Be the country-level contact for regulatory submission-related activities.
• Coordinate with internal departments to align site start-up activities with submissions.
• Support feasibility activities and maintain trial status information in tracking systems.
• Ensure country study files and filing meet SOPs and guidelines.

Conocimientos

Communication skills

Interpersonal skills

Attention to detail

Negotiation

Computer skills

English proficiency

Medical terminology

Teamwork

Organizational skills

Regulatory knowledge

Educación

Bachelor's degree

Equivalency considered

Descripción del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What You’ll Do:

• Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
• Provides project specific local SIA services and coordination of these projects.
• May have contact with investigators for submission related activities.
• Key-contact at country level for either Ethical or Regulatory submission-related activities.
• Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieves PPD’s target cycle times for site.
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• May develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
• Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Education and 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 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 and 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

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.