Medical Writer
3 weeks ago
Role: Medical Writer II
Location: Maple Grove, MN - 55311 (100% Onsite)
Duration: 12 Months
Shift: 8 AM to 5 PM
Key Responsibilities:
- Author Clinical Evaluation Reporting (CER) documents for Neuromodulation, CAHF, and Vascular products.
- Write and review deliverables like Clinical Evaluation Plans/Reports, PMS/PMCF Plans/Reports, SSCPs, and Regulatory Responses.
- Summarize clinical evidence from clinical investigations, literature, post-market surveillance, and risk data for product applications and submissions.
- Collaborate with stakeholders across departments for CER-related projects.
- Maintain expertise on assigned products and source, interpret, and evaluate data from various references.
- Review materials such as IFUs, Risk Management files, and training documents to ensure alignment and compliance.
- Support regulatory submissions, risk reviews, and responses to complex inquiries.
- Ensure documentation meets quality standards and adheres to applicable regulations (ISO13485, ISO14155, MEDDEV 2.7.1, MDR, FDA guidelines, etc.).
Qualifications:
Required:
- Bachelor’s degree or equivalent experience.
- 4-6 years of medical writing experience in the medical or pharmaceutical industry, or 7+ years of general technical writing experience.
- Experience in medical, pharmaceutical, clinical research, or related fields.
Preferred:
- Background in biomedical sciences, medicine, or health-related fields.
- Clinical Evaluation Report (CER) writing experience.
- Strong communication, analytical, and time management skills.
- Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.
- Experience working in collaborative, cross-functional teams.
-
Medical Writer
4 weeks ago
Maple Grove, United States Spectraforce Technologies Full timeJob Title: Medical Writer IILocation: Maple Grove, MN, 55311Duration: 12 MonthsDetails:The Sr. 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...
-
Senior Medical Writer
3 weeks ago
Maple Grove, United States SPECTRAFORCE Full timeJob Title: Medical Writer IILocation: Maple Grove, MN, 55311Duration: 12 MonthsPay Rate Starts from $42/hr on W2Details:The Sr. 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...
-
Medical Writer II
3 weeks ago
Maple Grove, United States Tek Support Full timeJob Overview:The Medical Writer II will author Clinical Evaluation Reports (CERs) and related documentation for Neuromodulation, CAHF, and Vascular products. The role involves summarizing clinical evidence, regulatory compliance, and collaboration across cross-functional teams.Key Responsibilities:Author Clinical Evaluation Plans/Reports, PMS/PMCF...
-
Medical Writer II
4 weeks ago
Maple Grove, United States Experis Full timeOur client, medical device manufacturing industry,?is seeking a medical writer to join their team. Job Title:?Medical Writer? Location: Maple Grove, MN, 100% Onsite? Duration: 12 months from the workers' start date Pay Range: $40-$45/hr on W2 ? What’s the job? Nature of role: authoring clinical evaluation reporting documents for the neuromodulation,...
-
Medical Writer
3 weeks ago
Maple Grove, United States Intellectt Inc Full timeRole: Medical Writer Location: Maple Grove, MNDuration: 12 MonthsShift Timings: 8 AM to 5 PMJob Description:Nature of role: authoring Clinical Evaluation Reporting documents for the Neuromodulation, CAHF and Vascular products. Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and...
-
Maple Grove, United States Intellectt Inc Full timeRole: Medical Writer II(Clinical Evaluation Report/CER)Location: Maple Grove, MN - 55311Duration: 12 MonthsSeeking a skilled Clinical Evaluation Writer to author Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS) Plans/Reports, PMCF Plans/Reports, SSCPs, and regulatory submissions for Neuromodulation, CAHF,...
-
Writer and Document Control Specialist
3 days ago
Forest Grove, United States VanderHouwen Full timeWriter and Document Control SpecialistOur client seeks a dependable Writer and Document Control Specialist who can support their team with technical writing projects. The ideal candidate is detailed but concise and works well independently.This position is onsite in Portland, OR.ResponsibilitiesCreate, edit, and maintain clear and concise work instruction...
-
Accountant I
3 days ago
Maple Grove, United States City of Maple Grove, MN Full timeSalary: $87,079.20 - $115,691.68 Annually Location : Maple Grove 55369, MN Job Type: Full-time- Benefit Earning Job Number: 2025-00005 Department: Finance Opening Date: 01/07/2025 Closing Date: 1/28/2025 11:59 PM Central Job SummaryAbout Maple Grove, MN Maple Grove is a forward-thinking, thriving community in the northwest suburbs of the Twin Cities...
-
Automotive Customer Service Advisor
2 days ago
Downers Grove, United States Castle of Chicagoland LLC Full timeAre you a Service Advisor, Service Consultant, or Service Writer who is looking for a new opportunity? Have you worked in customer service at a dealership or within automotive? Come join our team at Castle Automotive Group - we're looking to hire Service Advisors for our team at Castle Mazda in Downers Grove! Automotive Customer Service Advisor...
-
Workday Technical Application Manager
3 weeks ago
Downers Grove, United States Zurn Elkay Water Solutions Full timeWorkday Technical Application Manager The Company Zurn Elkay Water Solutions Corporation is a thriving, values-driven company focused on doing the right things. We're a fast growing, publicly traded company (NYSE: ZWS), with an enduring reputation for integrity, giving back, and providing an engaging, inclusive environment where careers flourish and grow....
-
Workday Technical Application Manager
3 weeks ago
Downers Grove, United States Elkay Full timeWorkday Technical Application Manager The Company Zurn Elkay Water Solutions Corporation is a thriving, values-driven company focused on doing the right things. We’re a fast growing, publicly traded company (NYSE: ZWS), with an enduring reputation for integrity, giving back, and providing an engaging, inclusive environment where careers flourish and...
-
Senior Civil Engineer II
1 day ago
Downers Grove, United States Sevan Multi-Site Solutions Full timeSenior Civil Engineer II Department:Civil, Zoning & Permitting Location:Downers Grove, IL Sevan Multi-Site Solutions is a veteran-owned business that provides fully customized, turn-key, program management and construction services at scale. We offer program management, site assessments, design, and engineering services for restaurants, grocery, gas...