Senior Medical Writer

Essential Functions

• Researches, 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 activities.
• Supports regulatory approval process through clinical evidence document formulation and responding to regulatory agency questions.
• 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.
• 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 activities.
• Creates and manages schedule of deliverables.
• Conducts training for medical writers, regulatory affairs and other functions, as needed.
• May supervise or mentor other medical writers, as assigned.

Essential Physical/Environmental Demands

• Lifting -- Not to exceed 50 lbs. – local practice may apply.
• 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 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.
• Able 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.

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.