[Remote] Country Approval Specialist - FSP- Israel at Thermo Fisher Scientific

Israel

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, Life SciencesIndustries

Requirements

BS degree or international equivalent
2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor
Ability to explain data to facilitate decision making processes to be data driven
Knowledge and understanding of clinical study protocols and essential regulatory requirements
Strong attention to detail and ability to take ownership of document accuracy
Ability to hold self and others accountable

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
Acts 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 activation
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
Maintains knowledge of and understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
Supports sites and study teams to achieve rapid site start up and facilitates communication with internal and external team members to ensure prompt site approval and study timelines are achieved

Skills

Key technologies and capabilities for this role

Regulatory SubmissionsCountry SubmissionsSite Start UpClinical TrialsMoH ApprovalsEC ApprovalsDocument ReviewAttention to DetailProject CoordinationCommunication

Questions & Answers

Common questions about this position

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

This is an office-based position with standard Monday-Friday hours and office environmental conditions.

What are the key responsibilities of the Country Approval Specialist?

The role involves preparing, reviewing, and coordinating local regulatory submissions like MoH and EC approvals, providing local regulatory strategy advice, and supporting site start-up to achieve rapid activation and study timelines.

What skills or qualities are essential for this role?

A strong attention to detail, ownership of document accuracy, accountability, and determination to deliver quality are essential, along with the ability to coordinate with internal and external teams.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes meaningful work with global impact, enabling career goals through resources for research and delivery of life-changing therapies, and fostering collaboration across clinical operations teams.

What makes a strong candidate for this position?

Strong candidates will have experience in regulatory submissions, the ability to work under guidance on local MoH and EC processes, and skills in coordinating with teams to meet site activation timelines.

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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