Not SpecifiedCompensation
Entry Level & New GradExperience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Position Overview

  • Location Type: Not Specified
  • Job Type: Full time
  • Work Schedule: Standard (Mon-Fri)
  • Environmental Conditions: Office
  • Company: Thermo Fisher Scientific (PPD® clinical research services)

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself 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.
  • May have contact with investigators for submission related activities.
  • Acts as key-contact at country level for either Ethical or Regulatory 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.
  • 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 understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Requirements

  • Education and Experience:
    • 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).
    • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • Knowledge, Skills, Abilities:
    • Effective oral and written communication skills.
    • Excellent interpersonal skills.

Skills

Regulatory Submissions
Clinical Trial Documentation
Country Approval Processes
Regulatory Strategy
Attention to Detail
Ownership & Accountability

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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