Principal Medical Writer

🕒 il y a 3 jours

🌽 Illinois – Distant

🌽 Illinois – Remote

💵 $109 500 - $208 500 / an

⏰ Temps Plein

🔴 Expert

🏥📝 Rédacteur Médical

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

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AbbVie

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 2013

🏥 Santé

💼 Conseil

🏭 Fabrication

Healthcare • Consulting • Manufacturing

AbbVie est une entreprise pharmaceutique mondiale qui découvre et fournit des médicaments et des solutions innovants pour améliorer les vies. Axée sur le traitement des défis de santé les plus difficiles au monde, AbbVie opère dans plus de 175 pays, offrant une large gamme de produits dans des domaines tels que l'immunologie, l'oncologie, les neurosciences et les soins esthétiques. Engagée dans l'innovation scientifique, AbbVie investit massivement dans la recherche et le développement, visant à produire des médicaments de premier ordre. L'entreprise met également l'accent sur la diversité au sein du lieu de travail, la durabilité et les initiatives de soutien aux patients, assurant un impact positif tant pour ses patients que pour la communauté au sens large.

Description

• Provide advanced medical writing expertise and scientific publication or clinical regulatory document support to clinical teams • Lead complex scientific publications and clinical regulatory documents associated with filings and dossiers • Prepare abstracts, posters, oral presentations, manuscripts, and comprehensive clinical regulatory submission packages • Serve as a department representative on project teams and subject matter expert for assigned therapeutic or product areas • Interface with PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, and Publishing groups • Convert, interpret, and explain scientific data for target audiences and regulatory or journal/congress requirements • Coordinate review, approval, production, and delivery of scientific publishing and clinical regulatory projects • Arrange and conduct team review meetings and ensure required documentation is completed • Advise teams on compliance with US and international regulations, journal/congress guidelines, ICH requirements, templates, and SOPs • Communicate deliverables, writing processes, and timelines; negotiate outcomes and resolve conflicts and document content issues • Work with Regulatory Quality Assurance during clinical regulatory document audits and draft responses as needed • Recommend and implement tactical process improvements • Mentor and guide junior medical writers as needed

🎯 Exigences

• Bachelor's degree in English or Communications with relevant science expertise, or bachelor's degree in Life Science with relevant writing expertise • 3–4 years of relevant industry experience in medical writing in healthcare or academia, or related quality, regulatory, clinical research, or product support/R&D experience • American Medical Writing Association (AMWA) certification or other certification preferred • High-level content writing experience with all types of clinical publications or clinical regulatory documents • Expert ability to assimilate and interpret scientific content and translate it for appropriate audiences • Working knowledge of statistical concepts and techniques • Expert knowledge of US and international regulations, requirements, and guidance for scientific publications or clinical regulatory document preparation and submissions • Knowledge and expertise with Common Technical Document content templates • Expert knowledge of current electronic document management systems and information technology • Excellent written and oral communication skills • Superior attention to detail and ability to correct spelling, punctuation, grammar, consistency, clarity, and accuracy errors • Experience working with collaborative, cross-functional teams, including project management experience • Expert proficiency in word processing, flow diagrams, and spreadsheets • Excellent working knowledge of software programs in a Windows environment

🏖️ Avantages

• Paid time off (vacation, holidays, sick) • Medical insurance • Dental insurance • Vision insurance • 401(k) • Eligibility to participate in long-term incentive programs