Document Review Specialist II - Medical Writing

India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor's degree or equivalent qualification, with at least 2 years of relevant experience in the pharmaceutical or CRO industry preferred. Experience working in a client-dedicated role or with multiple clients in a CRO setting is also preferred. A strong understanding of medical terminology, statistical concepts, GCP, ICH guidelines, and FDA requirements is necessary.

Responsibilities

The Document Review Specialist II will meticulously review regulatory documents, including submissions, protocols, clinical study reports, and investigator's brochures, ensuring adherence to quality standards, templates, and industry guidelines. Responsibilities include verifying scientific logic and data accuracy against source documents, editing for clarity and consistency, and communicating proactively with authors to resolve queries. The specialist will maintain up-to-date knowledge of regulatory guidelines and industry standards, adjusting schedules to accommodate priority reviews.

Skills

Document Review

Medical Writing

Regulatory Documents

Clinical Study Reports

Investigator's Brochures

Patient Safety Narratives

Quality Standards

Editorial Style Guides

English Proficiency

Attention to Detail

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.

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