Associate Country Approval Specilist

United Kingdom

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor's degree or equivalent, with 0-2 years of relevant experience. Essential skills include effective oral and written communication, strong interpersonal abilities, meticulous attention to detail, good negotiation skills, proficiency in computer use, and excellent English language proficiency. Basic knowledge of medical terminology, teamwork, organizational skills, and an understanding of regional regulatory guidelines are also required.

Responsibilities

The Associate Country Approval Specialist will support the preparation, review, and coordination of country submissions, including local EC and MoH submissions, in alignment with global strategies. They will coordinate with internal departments to ensure site start-up activities align with submission timelines and critical paths for site activation. Responsibilities also include preparing regulatory compliance review packages, assisting with patient information and informed consent forms, supporting grant budget negotiations, maintaining trial status information in tracking databases, ensuring local country study files are properly maintained, and staying current with PPD SOPs, client SOPs, and regulatory guidelines.

Skills

Country Submissions

MoH submissions

Clinical Trials

Study Start Up

Regulatory Submissions

Documentation

Coordination

Attention to Detail

Communication

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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