Senior Medical Writer

Merit Medical Systems, Inc.; South Jordan (UT); On-site; USD 110,000 - 130,000; Full time

Job summary

A leading company in medical devices seeks a skilled Medical Writer to develop clinical evaluation reports and support regulatory processes. The role involves collaboration with cross-functional teams and requires strong writing and project management skills. Join us to make a difference in patients' lives while enjoying competitive benefits and a supportive work environment.

Benefits

Medical/Dental & Other Insurances

Low Cost Onsite Medical Clinic

Employee Garden | Gardening Classes

3 Weeks' Vacation

401K | Health Savings Account

Qualifications

• Five years of medical writing experience, preferably with CERs.
• Extensive knowledge of regulatory requirements for Clinical Evaluation Reports.

Responsibilities

• Researches, prepares, writes, edits and reviews clinical evidence documents.
• Supports regulatory approval process through clinical evidence document formulation.

Skills

Medical/technical writing skills

Project management skills

Interpersonal/verbal/written communication skills

Education

Bachelor's Degree in medical, biological, physical or engineering disciplines

Tools

Spreadsheets

Word processing

Job description

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 commitment. Together, we are making a difference in the lives of patients around the world.

WORK SHIFT

DAY (United States of America)

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. Also responsible for the maintenance of the related procedures, systems and processes. The primary focus will be on Clinical Evaluation Reports (CERs) and Summaries of Safety and Clinical Performance (SSCPs).

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.

SUMMARY OF MINIMUM QUALIFICATIONS

* Education and/or experience equivalent to a Bachelor's Degree in the medical, biological, physical or engineering disciplines and five years of medical writing experience, preferably with CERs.
* Extensive knowledge of regulatory requirements relative to Clinical Evaluation Reports.
* Proficient 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 documents.
* 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.
* Supervisory experience.
* 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 programs.

$110,000-$130,000 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

* Lifting -- Not to exceed 50 lbs. - local practice may apply.
* Writing
* Sitting
* Standing
* Bending
* Visual acuity
* Color perception
* Depth perception
* Reading
* Field of vision/peripheral

COMPETENCIES

* 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

COMMENTS

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.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.