[Remote] Sr Reg Publishing Spec at Thermo Fisher Scientific

Mexico

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Pharmaceuticals, BiotechnologyIndustries

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)
Ability to work in an office/laboratory and/or clinical environment
Tolerance for exposure to biological fluids with potential exposure to infectious organisms
Tolerance for exposure to electrical office equipment
Ability to use personal protective equipment such as protective eyewear, garments, and gloves

Responsibilities

Provides expertise in client submission deliverables supporting regulatory compliance
Prepares components of electronic regulatory submissions that meet electronic document requirements set by regulatory guidance, publishing documents and submissions that work with sponsor and/or regulatory agency software programs, and meeting consistency and security issues, under general supervision of the Manager, Electronic Publishing
Maintains document life cycle for submission documents
Leads the development and implementation of project-specific processes for sponsors with unique technology requirements
May act as the company's liaison for regulatory submission with the sponsor and assist the company's project teams in executing regulatory submission strategies
Provides leadership by participating in training, skill development, and mentoring of other electronic submission personnel, as needed
Uses professional judgment to evaluate the publishing needs in relationship to the overall project timelines, quality, and delivery
Engages other project team members, functional units, or publishing management as necessary to deliver final product and resolve/mitigate identified issues or barriers to delivery
Acts independently within a project team or as the project team lead to evaluate and deliver publishing tasks

Skills

electronic regulatory submissions

regulatory compliance

document lifecycle management

eCTD

submission publishing

regulatory guidance

project leadership

training

mentoring

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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