Edwards Lifesciences
Senior Manager, Clinical Science, Medical Affairs
Edwards Lifesciences, Irvine, California, United States, 92713
Senior Manager, Clinical Science, Medical Affairs
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives. How you'll make an impact
Provide scientific expertise throughout the development and implementation of clinical studies and evaluations for a dynamic portfolio of products across TMTT. Contribute to strategy and planning of clinical science and medical writing deliverables. Lead clinical study design and protocol development. Independently author complex documents, including clinical study protocols, reports, post‑approval study reports, clinical evaluation plans and reports, and other scientific documents. Independently author complex regulatory responses. Perform systematic literature reviews from initiation to completion. Review raw and summary clinical data for accuracy and resolve discrepancies. Interpret safety and effectiveness results from pre‑market and post‑market data sources; conduct systematic data appraisals to support overall benefit‑risk assessments. Collaborate with cross‑functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring accurate data reporting. Summarize key data from clinical studies and published literature and provide updates to stakeholders. Ensure documents comply with regulatory guidelines. May travel up to 15% to attend scientific conferences. What you’ll need (Required)
Bachelor’s Degree in a related field with 10 years of related experience in clinical science or medical/scientific writing; OR Master’s degree in a related field with 8 years of related experience in clinical science or medical/scientific writing. What else we look for (Preferred)
Doctorate degree (PhD, MD, PharmD) with 8 years of related experience in clinical science or medical/scientific writing. Familiarity with the coronary interventional and/or structural heart environments and current treatment options or other clinical and/or clinical trial experience. Experience in the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations. Experience with FDA PMA applications. Strong knowledge of scientific research methodology, device development process, GCP, ICH guidelines, and global regulatory frameworks. Experience working in a cross‑functional, collaborative environment and easy interaction with R&D engineers, regulatory specialists, statisticians, physicians, and support personnel. Excellent communication skills and experience influencing and guiding stakeholders. Recognized as an expert in own subject area with specialized depth within current or previous organization(s). Expert understanding of related aspects of clinical science and/or scientific/medical writing. Expert knowledge of regulatory requirements and study execution. Demonstrated ability to work independently, prioritize, and manage multiple tasks simultaneously. Strong knowledge of statistical analyses, study design methodologies, and clinical trial protocol development. Advanced working knowledge with MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat. Benefits and Compensation
We offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Equal Employment Opportunity
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement
All patient-facing and in-hospital positions require COVID‑19 vaccination. As such, if hired into a covered role, you will be required to submit proof that you have been vaccinated for COVID‑19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This requirement does not apply where it is prohibited by law.
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Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives. How you'll make an impact
Provide scientific expertise throughout the development and implementation of clinical studies and evaluations for a dynamic portfolio of products across TMTT. Contribute to strategy and planning of clinical science and medical writing deliverables. Lead clinical study design and protocol development. Independently author complex documents, including clinical study protocols, reports, post‑approval study reports, clinical evaluation plans and reports, and other scientific documents. Independently author complex regulatory responses. Perform systematic literature reviews from initiation to completion. Review raw and summary clinical data for accuracy and resolve discrepancies. Interpret safety and effectiveness results from pre‑market and post‑market data sources; conduct systematic data appraisals to support overall benefit‑risk assessments. Collaborate with cross‑functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring accurate data reporting. Summarize key data from clinical studies and published literature and provide updates to stakeholders. Ensure documents comply with regulatory guidelines. May travel up to 15% to attend scientific conferences. What you’ll need (Required)
Bachelor’s Degree in a related field with 10 years of related experience in clinical science or medical/scientific writing; OR Master’s degree in a related field with 8 years of related experience in clinical science or medical/scientific writing. What else we look for (Preferred)
Doctorate degree (PhD, MD, PharmD) with 8 years of related experience in clinical science or medical/scientific writing. Familiarity with the coronary interventional and/or structural heart environments and current treatment options or other clinical and/or clinical trial experience. Experience in the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations. Experience with FDA PMA applications. Strong knowledge of scientific research methodology, device development process, GCP, ICH guidelines, and global regulatory frameworks. Experience working in a cross‑functional, collaborative environment and easy interaction with R&D engineers, regulatory specialists, statisticians, physicians, and support personnel. Excellent communication skills and experience influencing and guiding stakeholders. Recognized as an expert in own subject area with specialized depth within current or previous organization(s). Expert understanding of related aspects of clinical science and/or scientific/medical writing. Expert knowledge of regulatory requirements and study execution. Demonstrated ability to work independently, prioritize, and manage multiple tasks simultaneously. Strong knowledge of statistical analyses, study design methodologies, and clinical trial protocol development. Advanced working knowledge with MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat. Benefits and Compensation
We offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Equal Employment Opportunity
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement
All patient-facing and in-hospital positions require COVID‑19 vaccination. As such, if hired into a covered role, you will be required to submit proof that you have been vaccinated for COVID‑19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This requirement does not apply where it is prohibited by law.
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