Senior Strategic Medical Writer & Regulatory Lead

BioSpace; Chicago (IL); On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie is seeking a Principal Strategic Medical Writer to lead and write clinical and regulatory documents across drug and device development. You will coordinate teams, drive writing processes, and ensure regulatory compliance across US/EU contexts.

Ideal candidates bring 5+ years in bio-pharma, strong scientific writing skills, and deep knowledge of ICH/GCP, regulatory guidelines, and project management. This role emphasizes cross-functional leadership and strategic document delivery.

Qualifications

• Minimum 5+ years in bio-pharma delivering medicines across therapeutic areas.
• Excellent written and oral communication with medical terminology knowledge.
• Proficient in assimilating and analyzing complex data.
• Experience writing/editing clinical and regulatory documents per ICH, GCP; familiarity with CONSORT/PRISMA.
• Advanced understanding of drug development, regulatory requirements, and study designs.
• Strong writing to explain complex science to stakeholders.
• Ability to oversee multiple projects with cross-functional teams.

Responsibilities

• Independently prepares clinical/regulatory documents for drug/device development.
• Coordinates review, approval, and quality control with other functions.
• Communicates deliverables, timelines, and writing process to team members.
• Leads and participates in project management strategies to meet submission objectives.
• Learns regulatory requirements and applies therapeutic area knowledge to projects.
• Drafts responses with R&D Quality Assurance as needed.

Skills

Written and verbal communication

Medical terminology

Data analysis

Regulatory document writing

Cross-functional collaboration

Project management

Education

Bachelor’s degree or higher (scienc e preferred)

Job description

AbbVie is seeking a Principal Strategic Medical Writer to lead and write clinical and regulatory documents across drug and device development. You will coordinate teams, drive writing processes, and ensure regulatory compliance across US/EU contexts.

Ideal candidates bring 5+ years in bio-pharma, strong scientific writing skills, and deep knowledge of ICH/GCP, regulatory guidelines, and project management. This role emphasizes cross-functional leadership and strategic document delivery.