Us To Help Unite Science Technology

Healthcare

PrincipalMedicalWriter

$300–450k ~AI est. Warsaw, Poland FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Principal Medical Writer at Us To Help Unite Science Technology. Skills: Clinical regulatory writing, Regulatory submissions, Data interpretation. Write clinical and regulatory documents. Work in matrix teams”

Industry & Context.

Healthcare
Problems you'll solve

Practical problem solving; Problem solving

What They're Looking For.

Must Have

5 years clinical regulatory writing experience, PhD or equivalent expertise, Master's degree with relevant experience, Working knowledge of ICH/GCP, Necessary computer skills, General computer literacy, Excellent English language skills

Nice to Have

PhD or equivalent expertise

What You'll Do.

Write clinical and regulatory documents

Deliver fit-for-purpose documents

Meet regulatory standards

Plan clinical dossiers

Produce clinical dossiers

Assess complex situations

Implement scientific solutions

Implement operational solutions

Implement submission solutions

Interpret complex clinical data

Synthesize trends in text

Synthesize trends in statistics

Organize content in reports

Organize messaging in summaries

Review analysis plans

Review reporting plans

Advise on table content

Speed document preparation

Mentor junior writers

Adapt to changing priorities

Adapt to changing therapeutic areas

Communicate in writing

How You'll Work.

Team & Collaboration

Matrix teams

Communication Scope

Oral communication; Written communication

Process & Methodology

Project management

Full Job Description

You will be a Principal Medical Writer who turns complex clinical and safety data into clear, regulatory-ready documents. You will work closely with clinical, safety, regulatory, statistics and programming colleagues. We value sound scientific judgement, practical problem solving and a collaborative mindset. This role offers growth through exposure to global submissions, process improvement and mentoring opportunities. Join us to help unite science, technology and talent to get ahead of disease together. **Key Responsibilities** : * Proven experience writing a wide range of clinical and regulatory documents (protocols, CSRs, CTD/NDA/MAA sections, IBs, briefing docs, regulatory responses). * Work effectively in matrix teams to deliver high-quality, fit-for-purpose documents meeting GSK and global/local regulatory standards. * Major contributor to planning and producing clinical dossiers for international regulatory submissions. * Managed projects of increasing scope and complexity with demonstrated effectiveness. * Understands cross-functional interdependencies (e.g., clinical pharmacology, biomarkers, health outcomes). * Quickly assesses complex situations and implements practical scientific, operational, and submission solutions. * Strong technical, statistical, and IT skills with ability to interpret complex clinical data. * Synthesizes trends in text and statistics to organize clear content and messaging in reports and summaries. * Reviews analysis and reporting plans, advising on table content and display; familiar with review tools and automation to speed document preparation. * Mentors junior writers, adapts to changing priorities/therapeutic areas, and communicates effectively both orally and in writing. **Qualifications and Experience** : * PhD or equivalent expertise (e.g., a master’s degree with relevant experience) * 5 years clinical regulatory writing experience in the pharmaceutical industry. * Possesses a good understanding of drug development. * Demon

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