Senior Strategic Medical Writer - Remote
AbbVie
August 22, 2026
Remote friendly (North Chicago, IL)
United States
$96,500 - $183,500 USD yearly
Medical Affairs
Senior Strategic Medical Writer
Responsibilities:
- Prepare clinical and regulatory documents for AbbVie drug and/or device development.
- Work with moderate autonomy on drafts; rely on subject matter experts and senior writers for verification and build knowledge of submission strategies.
- Coordinate review, approval, and quality control for clinical/regulatory projects; arrange and conduct review meetings.
- Produce and maintain compliant, quality-focused documents and ensure delivery within timelines; drive submission objectives with greater responsibility.
- Develop knowledge of US and international regulations, requirements, and guidelines for regulatory documentation.
- Participate in tactical process improvements.
- Identify and propose solutions to resolve questions/issues during writing, with appropriate resolution or escalation.
- Partner with leadership and R&D Quality Assurance to address inquiries and draft responses for an inspection-ready approach.
Qualifications:
- 4+ years of bio-pharmaceutical industry experience delivering medicines/therapies across therapeutic areas.
- Bachelor’s degree or higher (scientific discipline preferred).
- Outstanding written and oral communication skills and comprehensive medical/scientific terminology knowledge across therapeutic areas.
- Proficient in assimilating and analyzing complex data.
- Experience writing/editing clinical and regulatory documents per ICH/GCP and other regulatory requirements; familiarity with CONSORT and PRISMA; EU and US device writing experience is a plus.
- Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
- Excellent writing and ability to communicate complex information to stakeholders.
- Ability to oversee multiple projects; strong organizational, time management, and problem-solving skills.
Responsibilities:
- Prepare clinical and regulatory documents for AbbVie drug and/or device development.
- Work with moderate autonomy on drafts; rely on subject matter experts and senior writers for verification and build knowledge of submission strategies.
- Coordinate review, approval, and quality control for clinical/regulatory projects; arrange and conduct review meetings.
- Produce and maintain compliant, quality-focused documents and ensure delivery within timelines; drive submission objectives with greater responsibility.
- Develop knowledge of US and international regulations, requirements, and guidelines for regulatory documentation.
- Participate in tactical process improvements.
- Identify and propose solutions to resolve questions/issues during writing, with appropriate resolution or escalation.
- Partner with leadership and R&D Quality Assurance to address inquiries and draft responses for an inspection-ready approach.
Qualifications:
- 4+ years of bio-pharmaceutical industry experience delivering medicines/therapies across therapeutic areas.
- Bachelor’s degree or higher (scientific discipline preferred).
- Outstanding written and oral communication skills and comprehensive medical/scientific terminology knowledge across therapeutic areas.
- Proficient in assimilating and analyzing complex data.
- Experience writing/editing clinical and regulatory documents per ICH/GCP and other regulatory requirements; familiarity with CONSORT and PRISMA; EU and US device writing experience is a plus.
- Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
- Excellent writing and ability to communicate complex information to stakeholders.
- Ability to oversee multiple projects; strong organizational, time management, and problem-solving skills.