[Remote] Country Approval Specialist at Thermo Fisher Scientific

Argentina

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Maintains knowledge of and understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Responsibilities

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
Serves as 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
Enters 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

Skills

Key technologies and capabilities for this role

Regulatory SubmissionsMoH ApprovalsEC SubmissionsSIA CoordinationInformed Consent FormsSite ActivationFeasibility ActivitiesTrial TrackingSOP ComplianceGrant Budgets

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time position.

What is the work schedule and location for this role?

The work schedule is standard Monday-Friday in an office environment.

What are the main responsibilities or skills needed for the Country Approval Specialist role?

Key responsibilities include preparing and coordinating local regulatory submissions, providing local regulatory strategy advice, coordinating site start-up activities, and maintaining trial status information in tracking databases.

What is the work environment like for this position?

The role involves working under guidance in an office setting, coordinating with internal departments, investigators, and sites while following PPD SOPs, client SOPs, and regulatory guidelines.

What makes a strong candidate for this Country Approval Specialist position?

A strong candidate has regulatory experience in clinical trials, particularly with local submissions to MoH and EC, ability to coordinate cross-functionally under guidance, and knowledge of PPD SOPs and regulatory guidelines.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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