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

Title: Medical Writer II (Part-Time)

Location: St. Paul, MN

Duration: 12 Months

Part - Time - (Mon - Fri) (20 hrs/week)

Shifts: 8am to 12pm

100% Onsite

Summary: will work closely with the clinical scientist and clinical and risk evaluation teams and will 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.
• Must possess comprehensive written and verbal communication, analytical, 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: PMCF Medical Writing

• Lead the preparation of and draft post-market clinical follow up 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.
• Ensures 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.
• Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.

Consultants 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)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.