Medical Writer / Clinical Evaluation Reporting (CER)
Location: Maple Grove, MN; St. Paul, MN; Santa Clara, CA, USA
Category: Medical and Clinical Affairs
Work Type: On-site
Role Summary
The Medical Writer provides technical and strategic writing expertise for Abbott’s Regulatory Clinical Evaluation team. The role focuses on authoring Clinical Evaluation Reports (CER) and related regulatory documents for Neuromodulation, Structural Heart, and Electrophysiology products. The position requires knowledge of clinical study management, medical/scientific writing, quality engineering, risk management, and strong communication skills.
Key Responsibilities
Clinical Evaluation & Writing
Author and contribute to Clinical Evaluation deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses, and related documentation.
Evaluate and summarize clinical evidence from clinical investigations, literature, post-market surveillance, risk assessments, and post-market clinical evaluations.
Analyze clinical results for product applications and regulatory submissions.
Review IFUs, Patient Guides, Risk Management files, Clinical Evaluation Protocols, CERs/CEPs, and physician training materials to ensure alignment with risk information.
Collaboration & Project Support
Collaborate with Regulatory Affairs, Marketing Library Services, Product Performance Group, Quality Engineering, Clinical Affairs, Risk Management, and Medical Affairs to deliver CER-related outputs.
Support clinical, regulatory, quality, and engineering deliverables as assigned.
Contribute to responses for complex regulatory queries, including those from notified bodies.
Quality & Compliance
Ensure quality, consistency, and integrity in all deliverables and documentation.
Comply with corporate, divisional policies, and procedures, as well as regulations and guidance such as ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, EU and FDA guidance, and Abbott SOPs/DOPs.
Required Qualifications
Bachelor’s degree in a relevant technical discipline OR equivalent combination of education and work experience.
3+ years of progressively responsible experience as a technical writer in a medical or high-technology environment (preferably biotechnology).
Strong written/verbal communication, interpersonal, analytical, and project management skills.
Ability to multitask, prioritize, and meet deadlines in a fast-paced, matrixed, and geographically diverse environment.
Preferred Qualifications
Advanced degree in science, biomedical engineering, medicine, nursing, or a similar health-related discipline.
Experience in experimental design, data interpretation, and summarizing clinical data.
Knowledge of Abbott’s division products, quality systems, and medical technology.
3+ years of medical writing experience in the medical device or pharmaceutical industry, or 4+ years of general technical writing; experience in CER writing preferred.
Experience in Clinical Research, Product Development, Quality, or healthcare industry.
Proficiency with Word, Excel, PowerPoint, Outlook, and related software.
Experience with complaint handling, operation, or service of diagnostic instrumentation or medical technology.
Compensation
Base pay range: $60,000 – $120,000 (may vary by location)
Core Competencies
Clinical and scientific writing for regulatory documentation
Evaluation and summarization of clinical evidence
Cross-functional collaboration and project support
Regulatory compliance and adherence to quality standards
Analytical thinking, time management, and attention to detail
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
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Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |LA :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Tallinn |Hà Nội :
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Bishop | Melbourne | Switzerland | Nairobi | Slovakia | Lenexa | Xzagreb | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Green Way | Remote, USA | Texas | Ireland | Springville | Hammond | Remote - South America (Latin Americal) | Zaragoza | Minnesota | Remote | Medan | French | Tulsa | Hungary | Faridabad | Remote - Middle East | Victoria | Lousiana | Thailand | Remote - Africa | Manipal | Castlebar | Riga | Leinster | Belgium | Bountiful | McFarland |Republic of Colombia :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
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Niš |Bohemia :
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Santiago |Bosnia and Herzegovina :
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