Senior Medical Writer — Regulatory Strategy Leader

BioSpace; South Chicago Heights (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie is seeking a Principal Medical Writer to lead and write clinical and regulatory documents for drug and/or device development to support company objectives. You will coordinate cross-functional review, ensure timelines, maintain inspection-ready documentation, and apply US and international regulatory guidance.

The role requires 5+ years in bio-pharma with strong writing skills, attention to detail, and ability to manage multiple projects across teams.

Qualifications

• Minimum 5+ years in bio-pharmaceutical industry delivering clinical/regulatory documents.
• Strong knowledge of ICH, GCP, CONSORT, and PRISMA guidelines.
• Excellent writing and editing skills across multiple therapeutic areas.
• Ability to lead teams and manage timelines.

Responsibilities

• Independently prepares most clinical and regulatory documents for drug or device development.
• Coordinates reviews, approvals, and quality control across functions.
• Communicates deliverables, timelines, and process to teams.
• Leads and participates in process improvements.
• Develops expert knowledge of US and international regulations.
• Addresses inquiries with R&D QA and drafts responses.
• Learns product knowledge to support projects.
• Works with cross-functional teams to meet submission objectives.

Skills

Medical writing

Regulatory writing

Project coordination

Cross-functional collaboration

Communication

Education

Bachelor's degree or higher in scientific discipline

Job description

AbbVie is seeking a Principal Medical Writer to lead and write clinical and regulatory documents for drug and/or device development to support company objectives. You will coordinate cross-functional review, ensure timelines, maintain inspection-ready documentation, and apply US and international regulatory guidance.

The role requires 5+ years in bio-pharma with strong writing skills, attention to detail, and ability to manage multiple projects across teams.