Senior Clinical Scientist

Primary Function of Position:

• This role requires expertise in analyzing medical literature and clinical trial data to develop clinical evaluation documents for regulatory compliance.
• The position works collaboratively to create strategies for Clinical Evaluation Plans and Reports to obtain and maintain EU market clearance.

Essential Job Duties:

• Interact with cross-functional teams to plan and develop CEPs and CERs for new products requiring CE Mark.
• Author clinical documentation for regulatory submissions and develop responses to regulatory authority inquiries.
• Participate in literature searches to maintain knowledge and provide clinical guidance for product development.

Qualifications:

• Required skills include 5-8 years of medical writing experience, strong analytical abilities, and expertise in technical scientific writing.
• Required education is an MD, PhD, or M.S. degree in a scientific field, with preference for 2-4 years of CER writing in the medical device industry.
• The role demands excellent attention to detail, the ability to manage multiple projects, and strong communication and interpersonal skills.