[Remote] Ctry Approval Spec at Thermo Fisher Scientific

Brazil

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical TrialsIndustries

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)
Ability to work in an office/laboratory and/or clinical environment
Tolerance for exposure to biological fluids with potential exposure to infectious organisms
Tolerance for exposure to electrical office equipment
Ability to use personal protective equipment such as protective eyewear, garments, and gloves
Knowledge of and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Responsibilities

Prepares, reviews, and coordinates, under guidance, regulatory submissions to EU CTIS (and additional special national local applications if applicable, e.g., gene therapy approvals) in alignment with global submission strategy
Provides, under guidance, local regulatory strategy advice (MoH and/or EC) to internal clients
Serves as key-contact at country level for either Ethical or Regulatory submission-related activities
May have contact with investigators for 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
Enters and maintains trial status information relating to start up 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

EU CTISRegulatory SubmissionsLocal Regulatory StrategyMoHECEthical SubmissionsSite Start-upInformed ConsentTrial TrackingSOP ComplianceClinical Research

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A Bachelor's degree or equivalent and relevant formal academic/vocational qualification is required, along with previous experience comparable to 2+ years that provides the necessary knowledge, skills, and abilities.

Is this a remote position or does it require office work?

Work is performed in an office/laboratory and/or a clinical environment with standard office hours (40 hours per week).

What is the salary or compensation for this position?

This information is not specified in the job description.

What are the main responsibilities in this role?

The role involves preparing, reviewing, and coordinating regulatory submissions to EU CTIS and local applications, providing local regulatory strategy advice, coordinating with internal departments for site start-up activities, and maintaining trial status information and study files.

What working conditions should I expect?

The position involves standard office hours (40 hours per week) in an office, laboratory, or clinical environment, with potential exposure to biological fluids, infectious organisms, electrical equipment, and requires personal protective equipment like eyewear, garments, and gloves.

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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