Senior Medical Writer, Clinical Evaluation

Responsibilities

• Author and contribute to Clinical Evaluation reporting deliverables, including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, and SSCPs
• Evaluate and summarize clinical evidence from sources such as clinical investigations, literature, and post-market surveillance
• Collaborate with cross-functional stakeholders in R&D, Regulatory Affairs, Quality Engineering, and Clinical Affairs to support CER projects
• Review IFUs, patient guides, and Risk Management files to ensure alignment of risk information
• Ensure all documentation complies with applicable regulations and guidance, including ISO 13485, MDR, and FDA guidance
• Maintain thorough knowledge of assigned products and identify appropriate sources of relevant clinical data

Requirements

• Bachelor's degree in Science, Medical Technology, or an equivalent technical degree
• Minimum 3 years of relevant experience in R&D, Technical Product Development, or Quality within the healthcare industry
• Proven experience writing, editing, and managing engineering and technical documentation
• Strong analytical, project management, and interpersonal communication skills
• Ability to prioritize and manage a large volume of projects simultaneously to meet strict deadlines

Preferred Qualifications

• Advanced degree in science, biomedical engineering, medicine, or nursing
• 3+ years of medical writing experience specifically in the medical device or pharmaceutical industry
• Direct experience with Clinical Evaluation Report (CER) writing
• Knowledge of Quality systems and medical technology
• Proficiency in experimental design, data interpretation, and summarizing clinical data

Benefits

• Career development opportunities within an international company
• Eligibility for free medical coverage via the Health Investment Plan (HIP) PPO plan
• Excellent retirement savings plan with high employer contributions
• Tuition reimbursement and student debt assistance programs
• Access to FreeU education benefits for obtaining a bachelor's degree

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.