Meril Hiring for Sr. Officer/ Jr. Executive at Pardi, Gujarat, India Full Time

• 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 Master’s Degree or PhD (preferred) in a scientific discipline.
• At least 1-3 years CER writing experience with solid knowledge of Med Dev 2.7/1, rev 4.
• At least 1-3 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