Principal Strategic Medical Writer

AbbVie

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

Posted 10/22/2026full-timeRemote • Illinois • United StatesLead💰 $109,500 - $208,500 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 ICH guidelines and GCP, while effectively collaborating with cross-functional teams to achieve submission objectives. Possesses strong organizational and communication skills to oversee multiple projects and ensure quality control throughout the document development process.

Highest-signal resume keywords

Clinical Document WritingRegulatory Document PreparationProject Management StrategiesKnowledge of ICH GuidelinesCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Document WritingRegulatory Document PreparationData AnalysisKnowledge of ICH GuidelinesUnderstanding of Drug DevelopmentClinical ResearchBiostatisticsPharmacologyMedical TerminologyEditing Skills

Soft Skills

Outstanding Written CommunicationOutstanding Oral CommunicationOrganizational SkillsTime ManagementProblem-Solving Skills

Industry Keywords

Bio-Pharmaceutical IndustryGlobal PharmaBiotechLife ScienceHealthcare AuthorityCONSORT GuidelinesPRISMA GuidelinesGCPRegulatory RequirementsTherapeutic Areas

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
Independently prepare clinical and regulatory documents needed for development of AbbVie drugs and/or devices
Coordinate review, approval, and quality control across functions
Arrange and conduct team review meetings
Collaborate with teams on document authoring and content strategies
Communicate deliverables, writing processes, and timelines
Hold team members accountable to agreed-upon project dates
Contribute to project management strategies and develop ability to lead team members toward submission objectives
Recommend, lead, and/or participate in tactical process improvements
Develop expert knowledge of US and international regulations and guidance for regulatory documentation
Identify and propose solutions to issues arising during the writing process, including resolution or escalation
Apply therapeutic-area and product knowledge to scientific and business improvement projects
Work independently with R&D Quality Assurance to address inquiries and draft responses while maintaining an inspection-ready approach

Requirements

What you’ll need

5+ years of bio-pharmaceutical industry experience in a 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
Extensive experience writing and editing clinical and regulatory documents following ICH guidelines, GCP, and other regulatory requirements
Familiarity with CONSORT and PRISMA guidelines
Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
Excellent writing skills
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 (vacation, holidays, sick)
Medical, dental, and vision insurance
401(k)
Eligibility to participate in long-term incentive programs