Utah, United States · Remote OK
Work Shift: DAY Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard …
Skills: Medical writing, Clinical evaluation reports, Regulatory affairs, Technical writing, Medical literature research
Venlo, Limburg, Netherlands · On-site
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Quality Assurance, ISO 9001, ISO 13485, Regulatory Compliance, Medical Device Manufacturing
South Jordan, Utah, United States · On-site
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Molding operations, TWI training, Startup inspections, Line clearance, Good manufacturing practices
California, United States · Remote OK
$63k–$112k/yr
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Sales, Account management, Product demonstration, Customer relationship management, Medical device sales
Texas, United States · Remote OK
$113k/yr
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Capital sales, Oncology, Business development, Strategic account management, Executive selling
Michigan, United States · Remote OK
$113k/yr
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Capital sales, Oncology, Business development, Strategic account management, Executive selling
South Carolina, United States · Remote OK
$113k/yr
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Capital sales, Executive selling, Business case development, Health system navigation, Strategic account development
California, United States · Remote OK
$113k/yr
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Capital sales, Oncology, Business development, Strategic account management, Hospital approval pathways
Sarasota, Florida, United States · On-site
Work Shift: DAY Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard …
Skills: Medical product assembly, Assembly line rotation, Quality inspection, Visual inspection, Fine motor skills
North Carolina, United States · Remote OK
Work Shift: DAY Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard …
Skills: Clinical training, Product education, Sales training, Curriculum development, Skill assessment
South Jordan, Utah, United States · On-site
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Fluoropolymer processing, PTFE, ePTFE, Stent manufacturing, Catheter manufacturing
South Jordan, Utah, United States · On-site
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Quality engineering, Failure investigation, Risk analysis, Quality inspection plans, Data collection
Colorado, United States · Remote OK
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Capital sales, Oncology, Business development, Strategic account management, Executive selling
Hills, Minnesota, United States · On-site
$23/hr–$31/hr
Work Shift: DAY Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard …
Skills: Quality control, Inspection, Documentation, Nonconforming material reports, Calibration
South Jordan, Utah, United States · On-site
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Inventory Management, Data Entry, Receiving, Cycle Counting, Forklift Operation
Canada · Remote OK
Work Shift: DAY Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard …
Skills: Product Training, Skill Assessment Testing, Training Curriculum Development, Product Troubleshooting, Interpersonal Communication
Virginia, United States · Remote OK
$63k–$112k/yr
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: New Client Establishment, Existing Account Maintenance, Product Demonstration, Customer Service, Customized Drawing Preparation
Tijuana, Baja California, Mexico · On-site
Work Shift: WKND Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard…
Skills: Production Supervision, Clean Room Maintenance, Personnel Management, Quality Assurance, Performance Evaluation
South Africa · Remote OK
Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitme…
Skills: Direct Sales, Medical Device Sales, Client Relationship Management, Oral Presentation, Business Mathematics
Pearland, Texas, United States · On-site
Work Shift: EVE Work Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard …
Skills: Extrusion Operation, Troubleshooting, Quality Inspection, Equipment Maintenance, Mathematical Calculations
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The Senior Medical Writer independently researches, prepares, and reviews clinical evidence documents such as CERs and SSCPs to support regulatory approval processes. They also collaborate with cross-functional teams, manage project schedules, and provide mentorship to other medical writers.
Candidates must possess a Bachelor’s degree in a medical, biological, physical, or engineering discipline along with at least five years of medical writing experience. Extensive knowledge of regulatory requirements, clinical evaluation reports, and proficiency in medical literature research are essential.
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
ESSENTIAL FUNCTIONS PERFORMED
1. Independently researches, prepares, writes, edits and reviews clinical evidence documents, e.g. CERs and SSCPs.
2. Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities.
3. Supports regulatory approval process through clinical evidence document formulation and responding to regulatory agency questions.
4. Manages and maintains the procedures, systems and processes required to meet regulatory requirements for clinical evidence documents and ensures they stay up-to-date based on guidance, regulation and feedback from regulators.
5. Collaborates with cross-functional teams to ensure high quality and successful project delivery.
6. Develops and maintains in-depth therapeutic and product operation knowledge; applies this knowledge to the development of well written clinical evidence documents.
7. Provides input to post-market surveillance and risk management activities.
8. Creates and manages schedule of deliverables.
9. Conducts training for medical writers, regulatory affairs and other functions, as needed.
10. May supervise or mentor other medical writers, as assigned.
11. Performs other duties and tasks, as required.
Infectious Control Risk Category III:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.
As an eligible Merit employee, you can expect the following:
Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
Medical/Dental & Other Insurances (eligible the first of month after 30 days)
Low Cost Onsite Medical Clinic
Two (2) Onsite Cafeterias
Employee Garden | Gardening Classes
3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
* 401K | Health Savings Account
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Understand. Innovate. Deliver.
As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care. Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.
Offices: Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095, US · Merit Netherlands-Maastricht, Amerikalaan 42; 6199 AE Maastricht Airport, Maaastricht, n/a, NL · West Jordan Facility, West Jordan, Utah 84088, US · Merit Virginia Facility, 12701 Kingston Ave, Chester, Virginia 23836, US · Parkmore Business Park West, Galway, Ballybrit D02 TD60, IE
Understand. Innovate. Deliver.
As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care. Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.
Offices: Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095, US · Merit Netherlands-Maastricht, Amerikalaan 42; 6199 AE Maastricht Airport, Maaastricht, n/a, NL · West Jordan Facility, West Jordan, Utah 84088, US · Merit Virginia Facility, 12701 Kingston Ave, Chester, Virginia 23836, US · Parkmore Business Park West, Galway, Ballybrit D02 TD60, IE
