Sr Executive
Sr Executive
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Job Description
To develop and write clinical evaluation reports (CER) for pre and postmarket 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 multitask prioritize and ensure reliability and quality while executing projects on time and on budget).
Strong written and oral communication skills.
Bachelors 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
Requirements
Must be focused efficient detail oriented andable to work independently.
Able to read analyze and implement regulationsstandards and guidance.
Demonstrated ability to manage projects (take minutesmultitask prioritize and ensure reliability and quality while executingprojects on time and on budget).
Strong written and oral communication skills.
Bachelors or Masters Degree or PhD (preferred)in a scientific discipline.
At least 3 years CER writing experience withsolid knowledge of Med Dev 2.7/1 rev 4.
At least 3 years clinical regulatory qualityand/or engineering work experience.
Able to productively interact with teamsincluding corporate executives research sites and research subjects.
Advanced computer skills with Word ExcelPowerPoint etc.
Benefits
Fresh Perspectives
Enhanced Skills and Expertise
Increased Productivity
Improved Morale
Broadened Network
Diversity and Inclusion
Knowledge Transfer
Required Experience:
Senior IC
Employment Type
Full-Time
