Sr Officer Jr Executive
Sr Officer Jr Executive
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Job Description
To develop and write clinical evaluation reports(CER) for pre and postmarket devices while ensuring consistency withregulations quality standards commitments and goals.
Writing coherent convincing CERs by organizingand evaluating large amounts of scientific/clinical/medical data.
Managing CER writing by planning identifyingappraising and analyzing clinical data then writing the CER includingconclusions based on expert knowledge.
Ensuring quality by following internal andexternal SOPs Work Instructions and Forms/Templates for successful preparationof robust CERs and other documents
Assisting with other clinical regulatoryquality and engineering projects as assigned
Responsible to acquire interpret analyze anddraw conclusions from clinical data from clinical trials literature andexperiences for a wide variety of medical devices
Responsible to communicate scientific content ina clear concise manner
Other duties as assigned
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 13 years CER writing experience withsolid knowledge of Med Dev 2.7/1 rev 4.
At least 13 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
