[Remote] FSP Document Review Specialist II (North America) at Thermo Fisher Scientific

Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, Life SciencesIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous editorial experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Experience working in the pharmaceutical/CRO industry preferred; if CRO experience, experience working in a client-dedicated role or with 1 to 2 clients over multiple projects preferred
In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related editorial experience
Capable of focusing on document details and the overall objectives and intent of document messaging
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
Attentive to detail and quality of documents, thorough
High English proficiency with the ability to communicate clearly and concisely
Solid understanding of regulatory document content
Experience working in a range of document management systems preferred

Responsibilities

Reviews highly technical scientific documents of all types developed within or outside of the company to ensure quality standards that meet or exceed client expectations
Verifies scientific logic and clarity of the document by verifying data in tables, listings, and figures 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
Effectively reviews regulatory documents, including but not limited to submissions documents, protocols and amendments, clinical study reports, investigator’s brochures, and patient safety narratives, to ensure quality standards and adherence to templates, client guidelines, editorial style guides, and industry standards
Collaborates with internal clients, supporting and enabling effective communication that results in operational excellence and quality deliverables

Skills

Key technologies and capabilities for this role

Document ReviewRegulatory DocumentsClinical ProtocolsClinical Study ReportsInvestigator’s BrochuresPatient Safety NarrativesDocument Management SystemsQuality StandardsEditorial Style GuidesEnglish Proficiency

Questions & Answers

Common questions about this position

Is this position remote?

Yes, this is a remote-based position.

What experience is required for this role?

A Bachelor's degree or equivalent and relevant formal academic/vocational qualification is required, along with previous editor experience. Experience working in a range of document management systems is preferred.

What are the key responsibilities of the Document Review Specialist II?

Key responsibilities include reviewing highly technical scientific documents for quality, verifying scientific logic and data accuracy, editing for consistency and grammar, revising language for clarity, and proactively querying authors while staying current with guidelines.

What skills are essential for success in this role?

The role requires meticulous attention to detail, high English proficiency with clear and concise communication, and a solid understanding of regulatory document content. Experience in reviewing regulatory documents like protocols, clinical study reports, and investigator’s brochures is key.

What is the work schedule for this position?

The work schedule is standard, Monday through Friday.

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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