[Remote] Principal Regulatory Publishing Spec at Thermo Fisher Scientific

India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Life SciencesIndustries

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 8+ years)
In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience
Ability to supervise, evaluate, and mentor departmental personnel
Ability to delegate tasks and facilitate completion of assignments
Demonstrated innovation in developing new ideas related to process improvements
Excellent knowledge of document management and electronic submissions
Excellent knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools, XML
Excellent knowledge of electronic templates and skilled in formatting and troubleshooting templates
Excellent organizational, analytical, and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
Ability to independently assess sponsor needs and work with project team members in producing compliant deliverables
Ability to independently learn new technologies
Excellent editorial/proofreading skills
Ability to lead a diverse staff
Ability to train and mentor others

Responsibilities

Prepares components of complex 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
Assists in the management of projects in the provision of regulatory publishing and submissions services
Acts as primary study contact or lead with internal and external clients
Provides leadership by participating in training, skill development, and mentoring of other regulatory publishing personnel, as needed
Assists in assessing sponsor needs and works with project team members in producing compliant deliverables
Serves in a quality review role, thoroughly reviewing documents created within or outside of the company to ensure quality of a standard that meets or exceeds both client’s expectations and federal requirements
Ensures the on-time delivery of a quality product to the sponsor
Ensures successful regulatory review outcomes for product milestones

Skills

Key technologies and capabilities for this role

Regulatory PublishingElectronic SubmissionseCTDDocument ReviewQuality AssuranceProject ManagementRegulatory ComplianceClient LiaisonMentoringTraining

Questions & Answers

Common questions about this position

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

A Bachelor's degree or equivalent and 8+ years of previous experience that provides the necessary knowledge, skills, and abilities are required. Equivalency with a combination of education, training, and directly related experience may be considered.

What key technical skills are needed for this position?

Excellent knowledge of Microsoft Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools, and XML is required. Proficiency in electronic templates, formatting, and troubleshooting templates is also essential.

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

The position is based in office environmental conditions with a standard Monday-Friday work schedule.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What leadership or soft skills are important for this job?

Skills in supervising, evaluating, and mentoring personnel, delegating tasks, organizational and analytical abilities to manage complex projects, and interpersonal skills for handling rapidly changing priorities are required.

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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