Thermo Fisher Scientific

Reg Publishing Spec

Mexico

Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor's degree or equivalent formal academic/vocational qualification and at least two years of relevant experience. Previous experience demonstrating knowledge of regulatory requirements and guidances for document management and electronic submissions is required. Familiarity with Microsoft Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools, and electronic templates is also necessary.

Responsibilities

The Reg Publishing Spec will coordinate and manage client electronic submission deliverables to support regulatory compliance, assist in preparing electronic document outputs that meet regulatory requirements, ensure that all final electronic deliverables meet current regulatory electronic document requirements, assist with developing and implementing project-specific processes for sponsors, evaluate publishing needs in relation to project timelines and quality, engage other team members to deliver final products and resolve issues, and act independently within a project team to evaluate and deliver publishing tasks. They will also serve in a quality review role, thoroughly reviewing documents to ensure quality meets or exceeds client expectations and may act as the company's liaison for electronic submissions with the sponsor.

Skills

Regulatory Submission
Electronic Document Preparation
Regulatory Compliance
Quality Review
Document Management
Regulatory Software

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.

Key Metrics

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