Principal Medical Writer
hace 3 semanas
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 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. Participates in internal and external audit activities to defend and/or explain document content to auditors and regulatory entities.
5. Creates, 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.
6. Collaborates with cross-functional teams to ensure high quality and successful project delivery.
7. Develops and maintains in-depth therapeutic and product operation knowledge; applies this knowledge to the development of well written clinical evidence documents.
8. Provides input to post-market surveillance and risk management activities.
9. Creates and manages schedule of deliverables.
10. Conducts training for Medical Writers, Regulatory Affairs and other functions, as needed.
11. Supervise and mentor other Medical Writers, as assigned.
12. Provide feedback and suggestions to RA Management to ensure top performance of the function.
13. Performs other duties and tasks, as required.
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
SUMMARY OF MINIMUM QUALIFICATIONS
- Education and/or experience equivalent to a Bachelor’s Degree in the medical, biological, physical or engineering disciplines and seven years of medical writing experience, preferably with CERs. Consideration will be given for advanced degrees relatable to the job.
- 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.
- 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.
- People management skills and experience are preferred.
- Demonstrated computer skills preferably spreadsheets, word processing, internet research and other applicable software programs.
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
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
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
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