[Remote] Document Review Specialist II at Thermo Fisher Scientific

India

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

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 5+ years)
Quality Review experience of CSR, Protocol, ICF, IB, IND Modules, and any other regulatory documents
Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's message
Good knowledge of the methods, techniques, and procedures of medical writing tasks
Strong analytical ability
Good working knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g., ICH), and requirements of the FDA and other international regulatory agencies
Detail oriented, thorough and methodical
Proficient grammatical and communication skills, both oral and written
Good organizational and planning skills
Proven ability to work effectively in a team environment
Advanced computer literacy and expertise
Good understanding of document management systems
Capable of working well under pressure and remaining motivated
Capable of working both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment

Responsibilities

Reviews highly technical documents of all types created within or outside of the company to ensure quality standard that meets or exceeds client's expectations
Verifies scientific logic and clarity of the document by verifying data in tables against source documents, checking for consistency according to current regulatory standards and guidelines
Edits for accuracy, consistency and grammatical correctness
Adjusts schedule to accommodate unexpected requests for priority review
Revises scientific language for usage, flow, clarity, and audience appropriateness
Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment
Maintains, communicates and applies knowledge of current guidelines, templates and industry standards
Ensures integrity of data in tables against source documents
Instructs others outside of the quality review group on the review process

Skills

Key technologies and capabilities for this role

Document ReviewQuality ReviewCSRProtocolICFIBIND ModulesRegulatory SubmissionsMedical WritingData VerificationScientific EditingRegulatory Standards

Questions & Answers

Common questions about this position

What education and experience are required for the Document Review Specialist II role?

A Bachelor's degree or equivalent and relevant formal academic/vocational qualification is required, along with previous experience comparable to 5+ years that provides the necessary knowledge, skills, and abilities.

What key skills and abilities are needed for this position?

Key skills include quality review experience of CSR, Protocol, ICF, IB, IND Modules and other regulatory documents; strong analytical ability; good knowledge of medical terminology, statistical concepts, GCP, ICH guidelines, and FDA requirements; detail-oriented approach; proficient communication skills; and ability to work in teams and under pressure.

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

The position is office-based with a standard Monday-Friday schedule and office environmental conditions.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for the Document Review Specialist II position?

Strong candidates have 5+ years of experience in quality review of regulatory documents like CSRs, protocols, and IND modules, solid knowledge of medical terminology, GCP, ICH guidelines, and FDA requirements, plus the ability to work collaboratively in teams, handle details while seeing the big picture, and perform under pressure.

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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