We Offer a Diverse, Stable, Work Environment with Full Health, Dental, & Educational Benefits for Our Permanent Employees.
Most of Our Jobs Are Either 100% Fully Remote, or Hybrid for those living within 60 miles of our corporate office.
Our Benefits Include Paid Holidays, Health Insurance, Dental Insurance, Occasional Free Staff Training, 401( K ), Paid Time Off, & Vision Insurance.
Please search Our Current Job Openings Below:
To apply, email your resume & cover letter to contact@clinucate.com with “ATTN: HR Dept.” and the name of the job title below in the subject, to our human resources department.
Senior Medical Writer- Remote
SUMMARY OF RESPONSIBILITIES
Employee will be 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 JOB QUALIFICATIONS
• Education and/or experience equivalent to a Bachelor’s Degree in the medical, biological, physical or engineering disciplines and at least 1 year of medical writing experience, or completion of formal medical writing training.
• 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 of team experience.
• Strong command of medical terminology & human anatomy & physiology
• 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.
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
WORK SHIFT
DAY (United States of America) – 100% Remote Position
HOURS
Full Time / 40 hours / Week / Full Employee Benefits After 90 Days Successful Employment
HIRING PAY RANGE:
$120,000 / yr to $160,000 / yr depending upon experience
APPLY
To apply you may email your resume & cover letter to contact@clinucate.com with “Attn: HR Dept.” and the name of the job title in the subject, to our human resources department.
Please be sure your phone number & contact information is current.
Someone from our team will contact you if we feel you are a good fit for the position.
Thank You for considering joining our team for your career advancement!
CLINUCATE 