Medical Writer

Ultradent Products Inc., the global name in oral health, is seeking a Medical Writer to join Ultradent's Clinical Evidence team. The Medical Writer is responsible for researching, drafting and reviewing technical documentation for medical device, drug and cosmetic products, while being able to convey technical concepts in a concise and effective manner within multifunctional teams. The medical writer will also provide input and support to project teams with respect to clinical evaluation requirements, claims management, and post-market clinical follow up.

• Provide input and support to project teams with respect to clinical evaluation requirements, claims management, and post-market clinical follow up.
• Acquire, interpret, analyze, and draw conclusions from clinical data from clinical trials, literature, and experiences for a wide variety of medical devices.
• Provide input and support review, approval, and maintenance of product claims based on testing and literature review.
• Author Clinical Evaluation Plans and Reports, and Post-Market Clinical Follow-up Plans and Reports.
• Design literature searches using relevant key words and based on product information, execute literature searches, and extract data from literature review.
• Develop and maintain reference libraries and claims databases.
• Train stakeholder on advertising and promotion regulations.
• Mentoring and training of new incoming team members.
• Provide input on clinical claims justification based on testing and literature review.
• Other duties assigned as necessary.
  
  

WHAT YOU’LL NEED TO SUCCEED AS A MEDICAL WRITER:

• BS minimum in applicable scientific/engineering field with experience in the medical device industry or clinical research.
• Knowledge related to technical writing in a clinical field.
• Knowledge related to FDA & EU MDR regulations.
• Ability to research, analyze and interpret complex information.
• Initiative and attention to detail, through independent research.
• Able to manage time efficiently and prioritize tasks.
• Able to manage complex tasks and handle multiple projects simultaneously.
• Strong interpersonal skills, ability to work with teams and be a self-initiator.
• Required Experience: 1-5 years.
  
  

What We’re Looking For In You

• Record of peer-reviewed scientific writing and/or regulatory and technical writing.
• Experience with Microsoft Office Suite and EndNote or other Reference Manager solutions; experience with Agile a plus.
• Experience with data analysis and data management for clinical research.
• Ability to read, understand, and extract data from technical reports and scientific studies.
• Strong ability to interpret and disseminate relevant product information.
• Understanding of statistical methods and statistical software.
• Ability to communicate verbally and in writing with individuals who are both experts and non-experts in the field.
• Working understanding of FDA and FTC Ad/Promo Regulations, 21 CFR Part 820, EU Medical Device regulations and ISO 13485.
• Excellent organization, technical and writing skills.
  
  

Ultradent is an Equal Opportunity and Affirmative Action Employer. We are a global culture where differences are sought after, welcomed, and embraced. All qualified applicants will receive consideration for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

VEVRAA Federal Contractor: For more information please contact us at Recruiting@ultradent.com.

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