[Remote] Sr Ctry Approval Spec at Thermo Fisher Scientific

Brazil

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Clinical Research, PharmaceuticalsIndustries

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 5+ 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

Responsibilities

Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, and additional special national local applications as applicable) in alignment with the global submission strategy
Coordinates with internal functional departments to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines
Ensures the submission process for sites and studies are aligned to the critical path for site activation
Maintains contact with investigators for submission-related activities
Serves as key-contact at country level for either Ethical or Regulatory submission-related activities
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 understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
May support the coordination of feasibility activities, as required, in accordance with agreed timelines

Skills

Key technologies and capabilities for this role

Regulatory SubmissionsEthics Committee ApprovalsMinistry of Health ApplicationsSite ActivationClinical Trial CoordinationSOP ComplianceRegulatory GuidelinesFeasibility ActivitiesInvestigator CommunicationStudy File Management

Questions & Answers

Common questions about this position

What education and experience are required for this Sr Country Approval Specialist role?

A Bachelor's degree or equivalent formal academic/vocational qualification is required, along with previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 5+ years.

What is the work schedule and environment for this position?

This is a full-time position with a standard Monday-Friday schedule, performed in an office, laboratory, and/or clinical environment with potential exposure to biological fluids, infectious organisms, and electrical equipment.

What are the main responsibilities in this role?

Responsibilities include preparing and coordinating local regulatory submissions, aligning site start-up activities with timelines, maintaining contact with investigators, serving as key country-level contact for submissions, and ensuring proper study file maintenance per SOPs.

Is this a remote position, or does it require on-site work?

Work is performed in an office, laboratory, and/or clinical environment, with no mention of remote work options.

What salary or compensation is offered for this role?

This information is not specified in the job description.

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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