Sr Medical Writer

Description:

Nature of Work:
Medical Device MDR compliant CERs, CEPs and SSCPs for Structural Heart and Neuromodulation Class III devices
The Medical Principal Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process.
Daily activities are related to authoring Clinical Evaluation Reporting documents for the Neuromodulation, CAHF and Vascular products.
Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed.
Top 3 Skills or Any Specific type of Experience you are looking for:
*Experience writing Medical Device MDR compliant CERs, CEPs and SSCPs
*Microsoft Office proficiency
*Structural Heart, Neuromodulation, or other medical device experience such as Clinical Study Management
*Education: A bachelor s degree is required along with 6-8 years of experience.
*Interview Process/Methods: 1) Phone Screen with HM, 2) In-Person and/or On-Camera interview with HM and 3 other persons.
Successful Backgrounds:
Bachelor s Degree or an equivalent combination of education and work experience
6-8 years of medical writing experience in the medical or pharmaceutical industry or 8+ years
general technical writing experience required
Experience may include writing experience in a medical, pharmaceutical, medical device, clinical
research, medical or research industry , or combination of these skills
Preferred
Biomedical, sciences, medicine or similar health related discipline preferred
CER writing experience preferred
Excellent written and verbal communication skills
Experience with collaborative, cross-functional teams.
Excellent analytical skills and ability to manage complex tasks and manage time effectively
Proficient with Word, Excel, PowerPoint, Outlook, etc.