Job Title – Medical Writer II
Our client in Plymouth, MN or Santa Clara, CA is looking for hardworking, motivated talent to join their team. Our client- is a global medical devices and healthcare company that is engaged in the discovery, development, and manufacture of medical equipment and healthcare products. Don’t wait… apply today!
What's in it for you?

• Pay rate or Pay range: $35.00/HR to $45.00/HR on a W2 basis.
• Onsite, Remote, or Remote Location Specific: Plymouth, MN or Santa Clara, CA (may be Open for Remote)
• Contract or Permanent: Contract
• Full-time or Part-Time: Full-time (40 hours/week)

• Clinical Evaluation Reporting / Medical Writer (CER). The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are related to authoring Clinical Evaluation Reporting documents for the Structural Heart and Vascular products. Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed.

• Writes and contributes to Clinical Evaluation reporting deliverables such as Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses, and other related documentation.
• Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations. Analyzes results in preparation for product applications and submissions.
• Collaborates with team members and stakeholders in planning for and supporting CER-related projects and processes.
• Supports additional clinical, regulatory, quality, and engineering-related deliverables as assigned.
• Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management, and Medical Affairs in completing clinical evaluation project-related deliverables.
• Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates, and incorporates information from various sources including literature, clinical data, and medical references.
• Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), and physician training materials, ensuring alignment of risk information. Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
• Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews, and other processes such as regulatory inquiries.
• 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 with applicable regulations and guidance (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.

• Bachelor’s Degree or an equivalent combination of education and work experience
• 4-6 years of medical writing experience in the medical or pharmaceutical industry or 7+ years of general technical writing experience is required.
• Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or a combination of these skills.
• CER writing experience is required.

• Biomedical, sciences, medicine, or similar health-related disciplines are preferred.
• Excellent written and verbal communication skills
• Experience with collaborative, cross-functional teams.
• Excellent analytical skills and ability to manage complex tasks and manage time effectively.
• Proficient with Word, Excel, PowerPoint, Outlook, etc.

• Medical, Dental, Vision, 401k
• Weekly pay with direct deposit
• Consultant Care support
• Free Training to upgrade your skills.
• Dedicated Career Partner to help you achieve your career goals.

Are you Interested?

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