Sr. Medical Writer

To develop and write clinical evaluation reports (CER) for pre- and post-market devices, while ensuring consistency with regulations, quality standards, commitments and goals.

• Writing coherent, convincing CERs by organizing and evaluating large amounts of scientific/clinical/medical data.
  
• Managing CER writing by planning, identifying, appraising and analyzing clinical data then writing the CER including conclusions based on expert knowledge.
  
• Ensuring quality by following internal and external SOPs, Work Instructions and Forms/Templates for successful preparation of robust CERs and other documents
  
• Assisting with other clinical, regulatory, quality and engineering projects as assigned
  
• Responsible to acquire, interpret, analyze and draw conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices
  
• Responsible to communicate scientific content in a clear, concise manner
  
• Other duties as assigned
  

Requirements

• Must be focused, efficient, detail oriented and able to work independently.
  
• Able to read, analyze and implement regulations, standards and guidance.
  
• Demonstrated ability to manage projects (take minutes, multi-task, prioritize and ensure reliability and quality while executing projects on time and on budget).
  
• Strong written and oral communication skills.
  
• Bachelor's or Masters Degree or PhD (preferred) in a scientific discipline.
  
• At least 3+ years CER writing experience with solid knowledge of Med Dev 2.7/1, rev 4.
  
• At least 3+ years clinical, regulatory, quality and/or engineering work experience.
  
• Able to productively interact with teams including corporate executives, research sites and research subjects.
  
• Advanced computer skills with Word, Excel, PowerPoint, etc.
  

Benefits

• Fresh Perspectives
  
• Enhanced Skills and Expertise
  
• Increased Productivity
  
• Improved Morale
  
• Broadened Network
  
• Diversity and Inclusion
  
• Knowledge Transfer