Medical Writer (Remote Opportunity)
Company: Merit Medical Systems, Inc.
Location: South Jordan
Posted on: June 2, 2021
SUMMARY OF DUTIES
Responsible for supporting the development and creation of
clinical, scientific, and regulatory documents in accordance with
procedures, European Medical Device Regulations, and US FDA
requirements. The primary focus will be on Clinical Evaluation
Reports (CERs) and Summaries of Safety and Clinical Performance
ESSENTIAL FUNCTIONS PERFORMED
- With minimal oversight, research, prepares, writes, edits, and
reviews clinical evidence documents, e.g. CERs and SSCPs.
- Conducts proofreading, editing, document formatting, review
comment integration, and document completion/approval
- Supports the regulatory approval process through clinical
evidence document formulation and responding to regulatory agency
- Collaborates with cross-functional teams to ensure high quality
and successful project delivery.
- Develops and maintains in-depth therapeutic and product
operation knowledge; applies this knowledge to the development of
well-written clinical evidence documents.
- Provides input to post-market surveillance and risk management
- Creates and manages a schedule of deliverables.
- Performs other duties and tasks, as required.
SUMMARY OF MINIMUM QUALIFICATIONS
- Education and/or experience equivalent to a Bachelors's degree
in the medical, biological, physical, or engineering disciplines
and three years of medical writing experience, preferably with
- Knowledge of regulatory requirements relative to Clinical
- Experienced in searching medical literature and databases for
clinical and technical information.
- Ability to read, analyze, and interpret regulations, technical
standards, guidance documents, test reports, clinical and medical
terminology, technical product information, and complex
- Knowledge of U.S. FDA regulations, the Medical Devices
Directive (93/42/EEC, as amended), EU Medical Device Regulation
(2017/745), and ISO 13485 Quality System Standards.
- Effective written and verbal communication skills in the area
of technical/clinical applications.
- Strong command of medical and surgical terminology.
- Working knowledge of statistics.
- Self-motivated, self-directing, strong attention to detail, and
excellent time management skills.
- Project management skills.
- Demonstrated computer skills preferably spreadsheets, word
processing, internet research, and other applicable software
- Medical/technical writing skills
- CER protocol and report development/writing
- Medical literature research skills
- Computer skills
- Interpersonal/verbal/written communication skills
- Project management skills
- Statistical knowledge/application
Merit Medical Systems, Inc., an Equal Opportunity Employer
M/F/D/V, is a dynamic, progressive, and innovative company with a
strong global presence. Our culture is highly energetic,
family-friendly, values its employees, and promotes them as
standard business practice. To see what it is like to work at Merit
take a look at our new recruiting video on YouTube at
www.youtube.com/meritmedical to see the video titled "Great people,
Great products, Great Company". Merit currently has the above
opening located in South Jordan, Utah. Excellent compensation and
benefits packages will be offered to the right candidate.
COMPANY HISTORY Merit Medical Systems, Inc. (NASDAQ, MMSI) was
founded in 1987 by Fred P. Lampropoulos. Merit develops,
manufactures, and markets single-use medical devices primarily for
diagnosing and treating cardiovascular and vascular disease. Merit
has been successful in introducing and marketing innovative,
high-quality products through its expertise in new product design
and its capabilities in injection and insert molding of plastics;
the application of its proprietary electronic and sensor-based
technologies; and wire, extrusion and catheter technologies. Merit
also develops and markets embolotherapeutic products for the
treatment of uterine fibroids, hypervascularized tumors, and
arteriovenous malformations. Embolotherapy procedures are primarily
performed by interventional radiologists and use bioengineered
microspheres to create targeted vascular occlusion and drug
delivery. The Company is utilizing its competitive advantages and
technologies to develop and offer products that address a wide
range of needs related to cardiology and radiology procedures
performed in hospitals. Sales are made primarily to U.S. hospitals
through a direct sales force. The Company markets its products in
over 60 countries worldwide, utilizing a direct sales force in
Europe, and distributors for the remainder of the world.
MERIT MEDICAL SYSTEMS, INC.
EQUAL OPPORTUNITY EMPLOYER M/F/D/V
Keywords: Merit Medical Systems, Inc., South Jordan , Medical Writer (Remote Opportunity), Other , South Jordan, Utah
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