Technical Writer

• Write Scientific Operations medical and technical documentation including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Literature Review Protocol (LRP), Literature Review Report (LRR), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Updates Report (PSUR) documents, and other medical and technical assessments based on available data inputs.
• Respond to inquiries from Health Authorities and Notified Body as it pertains to data and information presented in the documents written.
• Track and trend inquiries and responses to improve processes and increase speed to market.
• Translate insights into viable processes and solutions that create value.
• Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed.
• Communicate to drive alignment in strategy across different functions including Medical Affairs, Clinical Research, Quality, R&D, and Regulatory Affairs.
• Participate in workshops and projects/ initiatives to help define processes improvements.
• Support audits and inspections pertaining to Scientific Operations processes and reports.

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