FSP Bench Country Approval Specialist

ThermoFisher Scientific; Comisión de Fomento de Perú; Híbrido; ARS 850.000 - 1.200.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific in Argentina seeks a Country Approval Specialist to manage local regulatory submissions in alignment with global strategy. You will coordinate MoH/EC submissions, provide local regulatory advice, and liaise with internal teams to ensure timely site activations and study filings.

The role requires a Bachelor's degree and 2+ years of relevant experience, strong communication and regulatory knowledge, and the ability to work both independently and in a team within an office

Formación

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 2+ years experience in related role or similar environment
• Equivalency may be considered with combination of education and experience

Responsabilidades

• Prepares, reviews and coordinates local regulatory submissions (MoH, EC) in alignment with global strategy.
• Provides local regulatory strategy advice to internal clients.
• Coordinates project-specific local SIA services and manages submission-related activities.
• May liaise with investigators for submission-related tasks.
• Primary country-level contact for regulatory submission activities.
• Ensures site activation timelines align with submission processes and critical path.

Conocimientos

Oral and written comms

Interpersonal skills

Attention to detail

Negotiation skills

Computer skills

English proficiency

Medical terminology

Teamwork/independence

Organizational skills

Regulatory knowledge

Educación

Bachelor's degree or equivalent

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 skillsli>
• 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.