Medical Writer II
Location: Abbott Park, United States
Category: Medical and Clinical Affairs
Company: Abbott
Employment Type: Full-Time
Experience Required: Minimum 3 years in medical writing or related field
Compensation: USD $61,300 – $122,700 per year (may vary by location)
Job Overview
Abbott is seeking a detail-oriented and experienced Medical Writer II to support regulatory and clinical documentation activities for blood screening products. The role involves developing and managing technical documentation for global and domestic regulatory submissions, ensuring compliance with regulatory standards, and supporting product approval processes.
As a medical writing subject matter expert, the selected candidate will collaborate with cross-functional teams to prepare regulatory documents, product labeling, and clinical materials. This position plays a critical role in supporting the clearance and approval of medium-risk blood screening products and maintaining regulatory compliance across international markets.
Key Responsibilities
Regulatory Documentation Development
Create and update technical documentation for international and domestic regulatory submissions, including medium-risk blood screening products such as IVDR Class B and US Class II submissions.
Product Labeling and Clinical Documentation
Prepare product labeling materials, including vial labels, kit labels, instructions for use, clinical brochures, and related documentation to support product registration and commercialization.
Verification and Stability Records Management
Develop and maintain templated verification and stability records for blood screening products to ensure regulatory and quality compliance.
Troubleshooting and Technical Support Documentation
Create and update troubleshooting guides to support product performance and operational efficiency.
Cross-Functional Collaboration
Collaborate with internal stakeholders including Regulatory Affairs, Quality Assurance, Technical Teams, Marketing, Global Support Services, Assay Integration, Medical Affairs, and Product Safety to ensure accurate and timely documentation.
Process Coordination and Compliance
Coordinate document preparation activities by gathering required inputs, managing documentation systems, proposing improvements to templates and tools, and facilitating cross-functional meetings to ensure project completion.
Educational Qualifications
Bachelor’s degree in Science (Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, Pharmacology), Mathematics, Engineering, Medical Sciences, or related field preferred.
Equivalent combination of education and relevant professional experience may be considered.
Experience Requirements
Minimum 3 years of experience in medical writing, regulatory documentation, or a related scientific field.
Experience in regulatory submissions, technical writing, or clinical documentation within healthcare, diagnostics, or pharmaceutical industries preferred.
Core Competencies
Strong knowledge of medical writing standards and regulatory documentation processes.
Understanding of global and domestic regulatory submission requirements.
Excellent written and verbal communication skills with strong attention to detail.
Ability to manage multiple documentation projects and meet deadlines.
Proficiency in cross-functional collaboration and stakeholder coordination.
Strong analytical and organizational skills with a focus on quality and compliance.
About the Company
Abbott is a global healthcare leader delivering innovative technologies across diagnostics, medical devices, nutrition, and branded medicines. With operations in more than 160 countries, the organization is dedicated to advancing healthcare solutions that improve patient outcomes and enhance quality of life worldwide.
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