Country Approval Specialist / Contract Specialist

Argentina

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Medical DevicesIndustries

Requirements

Candidates should possess a Bachelor’s degree or equivalent formal academic/vocational qualification and at least 2+ years of relevant experience. Familiarity with medical/therapeutic area terminology and basic medical knowledge is preferred. Strong communication, interpersonal, and negotiation skills are required, along with proficient computer skills and the ability to learn new software.

Responsibilities

The Country Approval Specialist/Contract Specialist will prepare and review local regulatory submissions (MoH, EC, etc.), provide regulatory strategy advice, coordinate with internal departments and sites, draft and negotiate agreements with study sites, manage investigator grant budgets, and ensure compliance with PPD SOPs and client directives. They will also maintain trial status information, develop Patient Information Sheets/Informed Consent forms, and assess legal and operational risks, ultimately achieving target cycle times for site activations.

Skills

Regulatory submissions

Clinical trial coordination

Project management

Regulatory strategy

Documentation and filing

Communication with investigators

Budget negotiation

Feasibility activities

Database management

Knowledge of SOPs

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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