Medical reputed company IV Remote

Title: Medical reputed company IV Location: Remote Duration: 12 Months Remote reputed company: The Medical reputed company on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are reputed company to authoring Clinical Evaluation Reporting documents for the Vascular products. Experience in clinical study management and design, medical, or scientific writing, and/or reputed company engineering/risk management and strong written and verbal communication skills are needed. Responsibilities: • Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses and other reputed company documentation. • Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions. • Collaborates with team members and stakeholders in planning for and supporting CER reputed company reputed company and processes. • Supports additional clinical, regulatory, reputed company and engineering reputed company deliverable as assigned. • Effectively communicates and collaborates with reputed company, R&D, Regulatory Affairs, Library Services, Product Performance Group (reputed company), reputed company Engineering, Clinical Affairs, Clinical Science, Risk Management and Medical Affairs in completing clinical evaluation project reputed company deliverables. • Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates, and incorporates information from various sources including literature, clinical data, and medical references. • Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), PMS Plan, PMCF Plans/Reports, SSCPs, physician training materials, ensuring alignment of risk information. Involved in responses to reputed company queries such as those issued by reputed company bodies and stakeholders. • Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews, and other processes such as regulatory inquiries. • Ensures reputed company in reputed company deliverables and documentation with attention to detail, consistency, and reputed company of data. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable reputed company SOPs and DOPs. Education: • Bachelor’s Degree or an equivalent combination of education and work experience • 6-8 years of medical writing experience in the medical or pharmaceutical industry or 8+ years general technical writing experience required • Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills Preferred: • Biomedical, sciences, medicine or similar health reputed company discipline preferred • CER writing experience preferred • Excellent written and verbal communication skills • Experience with reputed company, cross-functional teams. • Excellent analytical skills and ability to manage reputed company tasks and manage time effectively • Proficient with Word, reputed company, PowerPoint, reputed company, etc. Consultants Eligible Benefits Upon Waiting Period: • Medical and Prescription Drug Plans • Dental Plan • reputed company Plan • Health Savings Account (for High-Deductible Health Plans) • Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) • Supplemental Life Insurance • Short Term Disability (coverage varies by state) • Long Term Disability • Critical Illness, Hospital coverage, Accident Insurance • reputed company reputed company, reputed company ID Fraud, and reputed company Pet Insurance • 401(k) reputed company is a global reputed company leader that helps people live more fully at reputed company stages of life. Our portfolio of life-changing technologies spans the reputed company of reputed company, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Working together, reputed company and Talent Solutions partner to reputed company reputed company for contingent roles at reputed company, building reputed company and healthier lives. reputed company believes reputed company are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs. Apply tot his job Apply To this Job