Manager, Clinical Science/Medical Writing
Manager, Clinical Science/Medical Writing, Transcatheter Mitral and Tricuspid Therapies (TMTT) Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring, with a rapidly growing portfolio of innovative and less invasive solutions.
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.
This is an exciting opportunity for an exceptional Clinical Scientist/Medical Writing professional (internally called Manager, Medical Affairs) to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up.
As a key member of the Clinical Science team, the Manager, Clinical Science/Medical Writing (the formal internal Edwards title is Manager, Medical Affairs) is responsible for providing scientific expertise throughout the development and implementation of clinical evaluations and /or clinical studies for a dynamic portfolio of products across TMTT.
The Manager will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.
This position can be an onsite or a hybrid role based at Edwards Lifesciences' corporate headquarters in Irvine, California, or can be a remote based role in the U.
S.
Key
Responsibilities:
Author clinical evaluation plans (CEPs), clinical evaluation reports (CERs), post-market clinical follow-up (PMCF) plans and reports, clinical trial protocols (pre- and post-market), study reports (e.
g.
, annual progress reports, clinical study reports), regulatory responses, and other scientific documents (as appropriate).
Partner with cross functions to lead clinical study design and clinical protocol development Partner with TMTT R&D, Clinical Affairs, Safety, Regulatory Affairs, QA, Biometrics, GHER (Global Health Economics & Reimbursement) and other subject matter experts to create documents and that effectively and clearly describe research results, product use, and other medical information.
Provide scientific support by interpreting safety and effectiveness results data, including data mining, compiling, analyzing, and summarizing data from all applicable sources Independently review and collaborate with cross-functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting Summarize key clinical evidence from published literature and provide updates to internal stakeholders (as appropriate) Correctly analyze clinical data/results and interpret outcomes to propose appropriate follow-up.
Ensure documents comply with regulatory guidelines Up to 15% travel to conferences/physician meetings Minimum Requirements:
Bachelor's Degree in a related field with 8 years of related experience working in medical affairs, clinical affairs and/or clinical science; OR Master's degree in a related field with 6 years of related experience working in medical affairs, clinical affairs and/or clinical science; OR Doctorate degree (PhD, MD, PharmD) with 4 years of related experience working in medical affairs, clinical affairs, and/or clinical science.
Preferred
Qualifications:
Familiarity with the coronary interventional and structural heart environments and current treatment options or have other clinical and/or clinical trial experience Experienced 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 (US FDA, EU MDR) regulations Experienced with literature reviews and various publication databases including PubMed and Embase.
Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.
Additional Skills and General Expectations:
Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Demonstrated experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Aligning our overall business objectives with performance, 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.
The base pay range for this position is $111,000 to $158,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.
g.
, qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.
As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.
If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.
This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination.
In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.
Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work.
From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
Recommended Skills Adobe Acrobat Analytical Biometrics Clinical Study Design Clinical Study Reports Clinical Trial Protocols Estimated Salary: $20 to $28 per hour based on qualifications.
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.
This is an exciting opportunity for an exceptional Clinical Scientist/Medical Writing professional (internally called Manager, Medical Affairs) to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up.
As a key member of the Clinical Science team, the Manager, Clinical Science/Medical Writing (the formal internal Edwards title is Manager, Medical Affairs) is responsible for providing scientific expertise throughout the development and implementation of clinical evaluations and /or clinical studies for a dynamic portfolio of products across TMTT.
The Manager will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.
This position can be an onsite or a hybrid role based at Edwards Lifesciences' corporate headquarters in Irvine, California, or can be a remote based role in the U.
S.
Key
Responsibilities:
Author clinical evaluation plans (CEPs), clinical evaluation reports (CERs), post-market clinical follow-up (PMCF) plans and reports, clinical trial protocols (pre- and post-market), study reports (e.
g.
, annual progress reports, clinical study reports), regulatory responses, and other scientific documents (as appropriate).
Partner with cross functions to lead clinical study design and clinical protocol development Partner with TMTT R&D, Clinical Affairs, Safety, Regulatory Affairs, QA, Biometrics, GHER (Global Health Economics & Reimbursement) and other subject matter experts to create documents and that effectively and clearly describe research results, product use, and other medical information.
Provide scientific support by interpreting safety and effectiveness results data, including data mining, compiling, analyzing, and summarizing data from all applicable sources Independently review and collaborate with cross-functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting Summarize key clinical evidence from published literature and provide updates to internal stakeholders (as appropriate) Correctly analyze clinical data/results and interpret outcomes to propose appropriate follow-up.
Ensure documents comply with regulatory guidelines Up to 15% travel to conferences/physician meetings Minimum Requirements:
Bachelor's Degree in a related field with 8 years of related experience working in medical affairs, clinical affairs and/or clinical science; OR Master's degree in a related field with 6 years of related experience working in medical affairs, clinical affairs and/or clinical science; OR Doctorate degree (PhD, MD, PharmD) with 4 years of related experience working in medical affairs, clinical affairs, and/or clinical science.
Preferred
Qualifications:
Familiarity with the coronary interventional and structural heart environments and current treatment options or have other clinical and/or clinical trial experience Experienced 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 (US FDA, EU MDR) regulations Experienced with literature reviews and various publication databases including PubMed and Embase.
Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.
Additional Skills and General Expectations:
Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Demonstrated experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Aligning our overall business objectives with performance, 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.
The base pay range for this position is $111,000 to $158,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.
g.
, qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world.
As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role.
If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement.
This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination.
In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.
Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work.
From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
Recommended Skills Adobe Acrobat Analytical Biometrics Clinical Study Design Clinical Study Reports Clinical Trial Protocols Estimated Salary: $20 to $28 per hour based on qualifications.
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