Country Approval Spec at Thermo Fisher Scientific

Taipei, Taiwan

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

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)
In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience
Effective oral and written communication skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently
Basic knowledge of all applicable regional/national country regulatory guidelines and EC regulations

Responsibilities

Preparing, reviewing, and coordinating, 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
Providing, under guidance, local regulatory strategy advice (MoH and/or EC) to internal clients
Providing project-specific local SIA services and coordination of these projects
Having contact with investigators for submission-related activities
Serving as key contact at country level for either Ethical or Regulatory submission-related activities
Coordinating, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensuring alignment of submission process for sites and study are aligned to the critical path for site activation
Achieving PPD’s target cycle times for site
Working with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
Developing country-specific Patient Information Sheet/Informed Consent form documents
Assisting with grant budgets and payment schedules negotiations with sites
Supporting the coordination of feasibility activities, in accordance with agreed timelines
Entering and maintaining trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
Ensuring the local country study files and filing processes are prepared, set up, and maintained as per PPD WPDs or applicable client SOPs
Maintaining knowledge of and understanding PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Skills

Regulatory Submissions

MoH Approvals

EC Submissions

SIA Services

Informed Consent Forms

Feasibility Coordination

Trial Tracking

Site Activation

Grant Budgets

CRA Coordination

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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