Medical Writer II - Part Time (20 hrs/week)

Location: St. Paul, MN | Duration: 12 Months | Part-Time (20 hrs/week, Mon–Fri, 8am–12pm) | 100% Onsite

About the role

Will work closely with the clinical scientist and clinical and risk evaluation teams and provide technical and strategic writing expertise to support the development and maintenance of clinical evidence documentation for medical devices marketed globally, with primary emphasis on European regulatory requirements.

Qualifications

• Bachelor’s degree in Science, Medical Technology, or related field.
• Minimum 3 years of relevant experience in a related area such as clinical research, medical writing, R&D, or Technical Product Development in the healthcare industry.
• Comprehensive written and verbal communication, analytical, and project management skills.
• Familiarity with PMCF requirements, EU MDR, and clinical evaluation processes.
• Ability to work independently and collaboratively in a cross-functional environment and to manage multiple projects and priorities simultaneously.

Responsibilities

• Lead the preparation of and draft post-market clinical follow-up (PMCF) documents, including PMCF Plans and PMCF Evaluation Reports, using data from clinical studies, registries, and post-market surveillance activities in accordance with EU MDR requirements and in coordination with the clinical evaluation team.
• Maintain updates to PMCF Plans and PMCF Evaluation Reports through the life cycle of the supported products.
• Draft and maintain Clinical Development Plans (CDPs).
• Support development of PMCF study/activity protocols, statistical analysis plans, and study reports, as applicable.
• Maintain thorough knowledge of supported products and identify appropriate sources of relevant data in order to interpret, evaluate, and incorporate information from various sources into clear, defensible clinical conclusions and benefit-risk assessments.
• Review clinical evaluation documents (e.g., CEPs, CERs, PSURs) for scientific and clinical accuracy.
• Collaborate with clinical and risk evaluation, regulatory, clinical, biometrics, and quality teams to ensure alignment with global requirements.
• Ensure quality in all deliverables and documentation with attention to detail, consistency, and integrity of data.
• Responsible for compliance with applicable corporate and divisional policies and procedures.
• Ensure compliance with applicable regulations and guidance (ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.

Benefits

Eligible benefits upon waiting period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking, and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)