Medical Writer - Clinical

Medical Writer - Clinical

Location: Abbott Park, IL

Onsite Flexibility: Remote

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $70.44 / Hour (USD)
• Shift / Schedule: Monday – Friday, Daytime Hours (40 hours per week). If not in PST, may have occasional meetings after 5 PM.
• 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 aClinical Evaluation Reporting / Medical Writer (CER) for Vascular Medical Devices. 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 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.

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

• 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.

Preferred Skills

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

Education Requirements

• Bachelor's Degree or an equivalent combination of education and work experience

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

• Candidates may be considered fully remote; however, they will not be eligible to convert to permanent associates.
• Must be close in geographical proximity to one of the following locations to pick up equipment and in the event that an on-site visit is required: Santa Clara, CA; St. Paul, MN; Maple Grove, MN; or Plano, TX.
• Selected candidate will start ASAP after screenings have cleared.

About the Client

This globalhealthcare innovator has spent more than 140 years at the forefront of medical technology, diagnostics, nutritional science, and pharmaceutical development, with its products reaching patients in more than 160 countries. The organization operates across four major business segments — medical devices, nutritional products, diagnostics, and established pharmaceuticals — and its innovations include groundbreaking continuous glucose monitoring technology, rapid diagnostic tests, minimally invasive cardiac devices, and nutritional solutions for patients across all life stages. With operations spanning more than 160 countries and a workforce that includes biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals, it is a certified Great Place to Work with 80 percent of employees reporting it as a great place to work, well above the national average. The culture is grounded in inclusion and innovation, with leadership investing in diverse talent through employee networks, mentorship programs, and cross-functional development opportunities that connect meaningful work to a clear global health mission.

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: 26-16334Industry: Healthcare

#LI-Onsite