Medical Writer - CER

Medical Writer - CER

Location: Maple Grove, MN

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $68.34 $70.44 / Hour (USD)
• Shift / Schedule: Monday Friday, Daytime Hours, 40 hours per week
• Travel Requirements: Onsite at a designated location (Maple Grove, MN preferred; Plano, TX or Santa Clara, CA also considered)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

We currently have an opportunity for a 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 Neuromodulation, CAHF, and Vascular products. Experience in clinical research, medical or scientific writing, and/or quality engineering/risk management, and strong written and verbal communication skills are needed.

Key Responsibilities

• Writes and contributes to Clinical Evaluation reporting deliverables including 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), PMS Plan, PMCF Plans/Reports, SSCPs, 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 Client SOPs and DOPs.

Required Skills

• Experience writing Medical Device MDR compliant CERs, CEPs, and SSCPs
• Microsoft Office proficiency (Word, Excel, PowerPoint, Outlook)
• Structural Heart, Neuromodulation, or other medical device experience such as Clinical Study Management

Preferred Skills

• Biomedical sciences, medicine, or similar health-related discipline preferred
• CER writing experience 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

Education Requirements

• Bachelor's Degree or an equivalent combination of education and work experience (required)
• Biomedical sciences, medicine, or similar health-related discipline (preferred)

Required Experience

• 6-8 years of medical writing experience in the medical or pharmaceutical industry, OR 8 years of general technical writing experience required
• Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical, or research industry, or a combination of these skills

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Important Notes

• Immediate start upon completion of screenings.
• Interview process: 1) Phone Screen with Hiring Manager; 2) In-Person and/or On-Camera interview with Hiring Manager and 3 other persons.
• To be considered for conversion, candidates must sit onsite at a designated location (Maple Grove, MN preferred; Plano, TX or Santa Clara, CA also considered). Fully remote workers will not be considered.

About the Client

This global healthcare innovator has been advancing medical science for more than 140 years, with products and technologies reaching patients in more than 160 countries across cardiovascular care, diabetes management, diagnostic testing, nutrition, and neuromodulation. Operating across four major business segments medical devices, nutritional products, diagnostics, and established pharmaceuticals the organization employs biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals who collaborate across cross-functional, international teams. A certified Great Place to Work, with 80 percent of employees confirming it as such (well above the national average), this organization is committed to inclusion, innovation, and developing the next generation of healthcare professionals.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-13279 Industry: Healthcare

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