Senior Strategic Medical Writer

AbbVie

. Lead and write clinical and regulatory documents for drug and/or device development .

Posted 10/22/2026full-timeRemote • Illinois • United StatesSenior💰 $96,500 - $183,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in writing and managing clinical and regulatory documents in compliance with US and international regulations, while effectively communicating complex scientific information to diverse stakeholders. Proven ability to coordinate cross-functional teams and drive submission objectives within project timelines.

Highest-signal resume keywords

Clinical And Regulatory Document WritingICH Guidelines ComplianceDrug Development KnowledgeCross-Functional Team CollaborationOutstanding Written And Oral Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Document PreparationRegulatory Document PreparationData AnalysisMedical Terminology ProficiencyBiostatistics UnderstandingPharmacology KnowledgeStudy Design FamiliarityQuality Control CoordinationSubmission Strategy DevelopmentProcess Improvement Participation

Soft Skills

Strong Organizational SkillsTime ManagementProblem-Solving Skills

Industry Keywords

Bio-Pharmaceutical IndustryGlobal PharmaBiotechLife ScienceHealthcare AuthorityGCPCONSORT GuidelinesPRISMA Guidelines

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead and write clinical and regulatory documents for drug and/or device development
Prepare clinical and regulatory documents needed for AbbVie drug and device development
Develop knowledge of submission strategies
Coordinate review, approval, and quality control across functions
Arrange and conduct team review meetings
Produce and maintain high-quality, compliant clinical and regulatory documents within project timelines
Take greater responsibility for driving submission objectives
Apply US and international regulations, requirements, and guidelines to regulatory documentation
Participate in tactical process improvements
Identify and propose solutions to issues arising during the writing process
Work with leadership and R&D Quality Assurance on inquiries and draft responses to support inspection readiness

Requirements

What you’ll need

4+ years of bio-pharmaceutical industry experience in global pharma, biotech, life science, or healthcare authority
Bachelor's Degree or higher required; scientific discipline preferred
Outstanding written and oral communication skills
Comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas
Proficient in assimilating and analyzing complex data
Experience writing and editing clinical and regulatory documents following ICH guidelines, GCP, and other regulatory requirements
Familiarity with CONSORT and PRISMA guidelines
Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
Excellent writing skills
Ability to communicate complex scientific and medical information to various stakeholders
Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams
Strong organizational, time management, and problem-solving skills

Benefits

Comp & perks

Paid time off, including vacation, holidays, and sick leave
Medical, dental, and vision insurance
401(k)
Short-term incentive programs
Remote work