[Remote] Senior Reg Publishing Specialist at Thermo Fisher Scientific

Poland

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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 experience and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Strong knowledge of regulatory requirements and recommendations for document management and electronic submissions
Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, and publishing tools
Ability to manage several complex projects in parallel and adapt to changing priorities
Sophisticated organizational skills and effective interpersonal skills
Solid understanding of medical terminology and regulatory guidelines

Responsibilities

Provides expertise in client submission deliverables supporting regulatory compliance
Prepares components of electronic regulatory submissions that meet the electronic document requirements set by regulatory mentorship
Maintains document life cycle for submission documents
Leads the development and implementation of project-specific processes for sponsors with outstanding technology requirements
May act as the company's liaison for regulatory submission with the sponsor
Provides leadership by participating in training, skill development, and mentoring of other electronic submission personnel
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 vital to deliver final product and resolve/mitigate identified issues
Acts independently within a project team or as the project team lead to evaluate and deliver publishing tasks

Skills

Key technologies and capabilities for this role

electronic regulatory submissionsdocument lifecycle managementregulatory complianceeCTDsubmission publishingproject leadershipmentoringregulatory requirements

Questions & Answers

Common questions about this position

What compensation and benefits are offered for this role?

The position offers competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits.

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

This information is not specified in the job description.

What key skills are required for the Senior Reg Publishing Specialist role?

Required skills include strong knowledge of regulatory requirements for electronic submissions, advanced proficiency in MS Word, MS Excel, Adobe Acrobat, electronic document management systems, and publishing tools, plus the ability to manage complex projects and strong organizational and interpersonal skills.

What is the company culture like at Thermo Fisher Scientific?

The company culture stands for integrity, intensity, involvement, and innovation, within an innovative, forward-thinking organization.

What experience is needed to be a strong candidate for this position?

Candidates should have a Bachelor's degree or equivalent and previous experience comparable to 5+ years, along with a solid understanding of medical terminology and regulatory guidelines.

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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