
Medical Writer IV
Libertyville, IL · FlexibleContract / Full-time$66–71/hrSeen 1 day agoSeen in employer's feed 1 day ago
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Job overview
The Medical Writer IV will support technical and strategic writing across product development and the product life cycle for a Regulatory Clinical Evaluation team. The role focuses on clinical evaluation reporting for vascular products, evaluating clinical evidence, aligning risk information across documentation, and ensuring quality, data integrity, and regulatory compliance. The position is a 12+ month contract, with onsite locations listed and possible remote work for qualified candidates near a client location.
Skills & qualifications
Skills
Qualifications
Full job description
Our client is seeking a Medical Writer IV to join their Regulatory Clinical Evaluation team. As a Medical Writer IV, you will support the technical and strategic writing needs across the product development and life cycle process. The ideal candidate will bring strong clinical evidence evaluation skills, a detail-oriented approach to high-integrity documentation, and the ability to collaborate effectively across cross-functional teams.
Job Title: Medical Writer IV
Location: On site at Santa Clara, CA; St. Paul, MN; Maple Grove, MN; or Plano, TX locations, with the possibility of fully remote for qualified candidates who are close to client location to pick up equipment. Remote associates are not eligible to convert to permanent roles; experienced remote contractors may be considered for the contingent role.
Pay Range: $66/hr. - $71/hr.
Job Title: 12+ Month Conract
What's the Job?
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Write and contribute to Clinical Evaluation Reporting deliverables, including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses, and related documentation for Vascular products.
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Evaluate and summarize clinical evidence from sources such as clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations; analyze results to support product applications and submissions.
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Collaborate with stakeholders to plan for and support CER-related projects, processes, and deliverables.
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Review and ensure alignment of risk information across IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), PMS Plans, PMCF Plans/Reports, SSCPs, and physician training materials.
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Ensure quality and compliance of all deliverables and documentation, maintaining data integrity and adherence to applicable regulations and Abbott SOPs/DOPs.
What's Needed?
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Bachelor’s Degree or an equivalent combination of education and work experience.
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6–8 years of medical writing experience in the medical or pharmaceutical industry, or 8+ years of general technical writing experience.
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Experience that may include medical, pharmaceutical, medical device, clinical research, medical/research industry writing, or a combination of these skills.
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Strong written and verbal communication skills, with the ability to work effectively in collaborative, cross-functional teams.
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Proficiency with Word, Excel, PowerPoint, Outlook, and strong analytical skills to manage complex tasks and timelines.
What's in it for me?
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Opportunity to contribute to clinical evaluation reporting for Vascular medical devices across the product life cycle.
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Work on high-impact regulatory documentation that supports submissions and responses to complex stakeholder queries.
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Collaborate with teams across Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management, and Medical Affairs.
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Build and apply expertise in clinical evidence evaluation, risk alignment, and regulatory-ready documentation.
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Join a team focused on quality, consistency, and integrity of data in compliance with applicable standards and guidance.
Days/Hours: Mon–Friday, daytime hours (40 hours per week). If not in PST, there may be occasional meetings after 5 pm.
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
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