Principal Strategic Medical Writer
About The Position
The Principal Strategic Medical Writer leads and writes clinical and regulatory documents for drug and/or device development in support of company objectives. The role independently prepares most clinical and regulatory documents needed for AbbVie drug and device development and coordinates cross-functional review, approval, and quality control. The writer communicates deliverables, processes, and timelines; holds team members accountable to agreed project dates; contributes to project management strategies; and helps drive submission objectives. The role also recommends and implements process improvements, develops expertise in US and international regulatory requirements, resolves or escalates writing-related issues, applies therapeutic area and product knowledge to scientific and business improvement projects, and works independently with R&D Quality Assurance to address inquiries and draft responses while maintaining inspection readiness.
Requirements
- At least 5 years of biopharmaceutical industry experience in a global pharma, biotech, life science, or healthcare authority delivering medicines or therapies to a broad market across various therapeutic areas.
- Bachelor's degree or higher; a scientific discipline is preferred.
- Outstanding written and oral communication skills and comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
- Proficiency in assimilating and analyzing complex data.
- Extensive experience writing and editing clinical and regulatory documents in accordance with guidelines and regulations such as ICH guidelines, GCP, and other regulatory requirements.
- Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors.
- Excellent writing skills and the ability to communicate complex scientific and medical information effectively to various stakeholders.
- Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams.
- Strong organizational, time-management, and problem-solving skills.
Nice To Haves
- Familiarity with industry standards such as CONSORT and PRISMA guidelines.
- EU and US device-writing experience.
Responsibilities
- Independently prepare most clinical and regulatory documents needed for the development of AbbVie drugs and/or devices.
- Coordinate review, approval, and quality control among functions involved in producing clinical and regulatory documents.
- Arrange and conduct team review meetings and work with teams on document authoring and content strategies.
- Communicate required deliverables, the writing process, and timelines to team members.
- Hold team members accountable to agreed-upon project dates.
- Contribute to project management strategies and develop the ability to lead team members in driving submission objectives.
- Recommend, lead, and/or participate in implementation and execution of tactical process improvements.
- Develop expert knowledge of US and international regulations, requirements, and guidance for regulatory documentation.
- Identify and propose solutions to issues and questions arising during writing, resolving or escalating them as appropriate.
- Learn and 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.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
