Senior Medical Writer: Clinical Evaluation Leader

Abbott; Maple Grove (MN); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage

Excellent retirement plan

Tuition reimbursement

FreeU education benefit

Global company recognition

Job summary

Abbott is seeking a Senior Medical Writer, Clinical Evaluation to join our Regulatory Clinical Evaluation team. You will provide technical and strategic writing for product development and life cycle processes, authoring Clinical Evaluation Reports and related documents for Neuromodulation, CAHF and Vascular products.

You will evaluate clinical evidence from investigations, literature, and post-market data, and collaborate with cross-functional teams to plan CER projects and regulatory

Qualifications

• Bachelor’s degree in Science or equivalent plus related work experience.
• Minimum 3 years in R&D, Technical Product Development or Quality in a healthcare industry.
• Strong written and verbal communication, interpersonal, presentation, analytical, and project management skills.
• Experience writing, editing and managing engineering and technical documentation for new products and improvements.
• Developing spreadsheets or databases for data capture, assembly and graphical presentation of metrics.

Responsibilities

• Author CER documents and related Clinical Evaluation materials (CER/CEP, PMS/PMCF).
• Evaluate clinical evidence from investigations, literature, and post-market data.
• Collaborate with team members and stakeholders on CER projects and processes.
• Support regulatory, quality and engineering deliverables as assigned.
• Ensure quality, data integrity and regulatory compliance in deliverables.

Skills

Science degree

3+ years experience

Strong communication

Technical writing

Project management

Data analysis

Organization

Education

Bachelor’s degree in Science or related

Advanced degree preferred

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Abbott is seeking a Senior Medical Writer, Clinical Evaluation to join our Regulatory Clinical Evaluation team. You will provide technical and strategic writing for product development and life cycle processes, authoring Clinical Evaluation Reports and related documents for Neuromodulation, CAHF and Vascular products.

You will evaluate clinical evidence from investigations, literature, and post-market data, and collaborate with cross-functional teams to plan CER projects and regulatory