[Remote] Sr. Regulatory Publishing Specialist at Thermo Fisher Scientific

India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Life Sciences, 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)
Strong knowledge of regulatory requirements and guidances for document management and electronic submissions
Strong working experience (more than 5 years) in Veeva Vault (binders, modular appendices)
Proficient in Microsoft Word formatting (macros, templates, or custom toolbars)
Experience in clinical and regulatory document level publishing, particularly in preparing submission-ready documents (e.g., CSR, IB, or eCTD modules)
Advanced knowledge of Microsoft Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools
Advanced knowledge of electronic templates and skilled in formatting and troubleshooting templates
Ability to manage several complex projects in parallel and adapt to changing priorities
Ability to exercise independent judgment in developing methods, techniques, and evaluation of criteria using defined procedures and practices
Ability to independently assess sponsor needs and work with project team members in producing compliant deliverables
Ability to independently learn new technologies
Advanced organizational skills and effective interpersonal skills
Advanced analytical ability and problem-solving capabilities
Strong knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies
Advanced editorial/proofreading skills
Detail-oriented, thorough, and methodical
Ability to create and follow timelines and conduct long-range planning
Ability to multitask performing numerous single or complex tasks without ignoring overall objectives
Ability to judge when to initiate changes and make final determinations in the presentation of data

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 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
Serves in a quality review role and is responsible for the thorough review of documents created within or outside of the company to ensure quality of standards meet or exceed client expectations

Skills

Key technologies and capabilities for this role

Regulatory PublishingeCTDICH GuidelinesElectronic SubmissionsDocument Lifecycle ManagementRegulatory ComplianceQuality ReviewSubmission Software

Questions & Answers

Common questions about this position

What experience level is required for this Sr. Regulatory Publishing Specialist role?

A Bachelor's degree or equivalent and previous experience comparable to 5+ years is required.

What are the key technical skills needed for this position?

Strong working experience (more than 5 years) in Veeva Vault (binders, modular appendices), proficiency in Microsoft Word formatting (macros, templates, or custom toolbars), and clinical/regulatory document publishing for submission-ready documents like CSR, IB, or eCTD modules are required. Advanced knowledge of MS Word, MS Excel, Adobe Acrobat, electronic document management systems, eCTD tools, and electronic templates is also essential.

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

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Sr. Regulatory Publishing Specialist position?

Candidates with 5+ years of experience in Veeva Vault, MS Word formatting, and regulatory publishing (e.g., eCTD modules, CSR, IB), plus advanced knowledge of document management systems and the ability to manage complex projects independently, will stand out.

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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