[Remote] Principal Medical Writer (Regulatory MW) at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; Advanced degree preferred
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years)
Experience in managing and directing complex Regulatory medical writing projects required
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Significant knowledge of global, regional, national and other document development guidelines
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, marketing application submissions, communications, etc
Strong project management skills
Excellent interpersonal skills including problem solving and decision-making
Strong negotiation skills
Excellent oral and written communication skills with strong presentation skills
Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook); willingness to utilize technology to support authoring efficiency

Responsibilities

Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients
Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies
May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
As an essential advisory member of the writing team, may provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development strategy, document types, regulatory requirements, and industry best practices
May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications

Skills

Key technologies and capabilities for this role

Medical WritingRegulatory WritingClinical Study ReportsStudy ProtocolsInvestigator BrochuresINDsMAAsClinical ResearchScientific Writing

Questions & Answers

Common questions about this position

What is the location or work arrangement for this Principal Medical Writer role?

This role is based in the United States with a standard Monday-Friday office work schedule and environmental conditions listed as office.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What education and experience are required for the Principal Medical Writer position?

A Bachelor's degree in a scientific discipline or equivalent is required, with an advanced degree preferred, along with previous experience comparable to 8+ years that provides the necessary knowledge, skills, and abilities.

What key skills are needed to succeed in this role?

Strong project management skills, excellent interpersonal skills including problem solving and negotiation, and the ability to multi-task, perform under stress, and handle variable tasks with changing conditions are essential.

What experience makes a strong candidate for this Principal Medical Writer role?

Candidates with experience in managing and directing complex Regulatory medical writing projects, requiring 8+ years of comparable expertise, along with the ability to lead initiatives on documents like protocols, CSRs, IBs, INDs, and MAAs, 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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