FSP Document Review Specialist I

Serbia

Apply with AI Apply

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

A Bachelor's degree or equivalent qualification is required, along with 0-2 years of relevant experience. Pharmaceutical or CRO industry experience is preferred, particularly in client-dedicated roles or with multiple clients. The role demands meticulous attention to detail, high English proficiency for clear and concise communication, and a solid understanding of regulatory document content. Basic knowledge of medical terminology, statistical concepts, GCP, ICH guidelines, and FDA requirements is necessary, as is computer literacy and familiarity with document management systems.

Responsibilities

The FSP Document Review Specialist I will review regulatory documents such as submissions, protocols, clinical study reports, investigator's brochures, and patient safety narratives to ensure adherence to quality standards, templates, client guidelines, editorial style guides, and industry standards. Responsibilities include verifying document content and data accuracy against source documents, editing for clarity and consistency, revising scientific language, querying authors for clarification, and maintaining knowledge of current guidelines and industry standards. The specialist will also collaborate with internal clients to support operational excellence and quality deliverables.

Skills

Document Review

Regulatory Documents

Protocols

Clinical Study Reports

Investigator's Brochures

Patient Safety Narratives

Quality Standards

Editorial Style Guides

Industry Standards

English Proficiency

Document Management Systems

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.

Land your dream remote job 3x faster with AI

Try Jobo Free