Senior Manager, Medical Affairs (Transcatheter Mitral and Tricuspid Therapies) Job at Edwards Lifesciences
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.
The TMTT Medical Affairs organization disseminates clinical evidence that is critical in realizing this mission. The Senior Manager, Medical Affairs will manage a team that focuses on strategy and execution of a broad range of medical affairs activities.
The Senior Manager is responsible for developing and implementing best practices for Medical Affairs activities, ensuring alignment with global colleagues and other business units, and driving results of key deliverables.
This role will be based at Edwards Lifesciences’ corporate headquarters in Irvine, California, or can be located remotely within the US.
Key Responsibilities:
Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables.
Manage and oversee development and execution of deliverables including:
Data dissemination – lead continuous updates and dissemination of new clinical data to physicians upon request
Medical information – lead timely response to medical inquiries related to TMTT therapies
Medical education – lead provision of content upon request for continuing medical education
Investigator-initiated studies – oversee process of evaluating and funding of medical research grant requests
Educational grants – oversee process of evaluating and funding of medical education grant requests
Publication support – lead review of externally initiated manuscripts for accuracy of content related to TMTT therapies
Scientific conferences – lead key session identification and provision of medical information to physicians upon request
Health care provider contracts – oversee contracts and payments for medical affairs
Identify risk, develop and lead in the implementation of broad and complex cross-functional Medical Affairs strategies, which may include negotiations with internal and external parties and cross functional teams.
Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams.
Manage operational activities, including process improvements, budgeting, and financial forecasting. Provide regular status updates on budget and deliverables. Formulate go-forward plans based on data analyses.
Create robust talent development plan for the team.
Other incidental duties
Minimum Requirements
Bachelor’s degree with 10 years of medical/scientific experience in clinical affairs, medical affairs, medical information, medical communication, and/or medical education within the medical device or biopharma industries
OR
Master’s degree with 8 years of medical/scientific experience in clinical affairs, medical affairs, medical information, medical communication, and/or medical education within the medical device or biopharma industries
OR
Doctorate degree with 6 years of medical/scientific experience in clinical affairs, medical affairs, medical information, medical communication, and/or medical education within the medical device or biopharma industries
Preferred Qualifications
Clinical knowledge in interventional cardiology is strongly preferred
Knowledge and understanding of compliance, regulatory, and legal policies related to medical affairs activities
Experience adhering to quality and compliance standards in a regulated environment
Understanding of clinical study lifecycle and clinical data dissemination
Customer service orientation and strong verbal and written communication skills
Management of direct report(s)
Additional Skills and General Expectations:
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions, including hire/fire authority and partnering with HR on all aspects of employee relations
Excellent problem-solving, organizational, analytical and critical thinking skills, including high discretion/judgment in decision making
Relationship management skills with ability to drive achievement of objectives
Demonstrated ability to develop external partnerships and drive alignment of objectives
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Proven expertise in Microsoft Office Suite and related tools and systems
Strict attention to detail
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 $128,000 to $181,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).
About Edwards Lifesciences
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 13,000 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.
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.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
Please Note :
www.bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
The TMTT Medical Affairs organization disseminates clinical evidence that is critical in realizing this mission. The Senior Manager, Medical Affairs will manage a team that focuses on strategy and execution of a broad range of medical affairs activities.
The Senior Manager is responsible for developing and implementing best practices for Medical Affairs activities, ensuring alignment with global colleagues and other business units, and driving results of key deliverables.
This role will be based at Edwards Lifesciences’ corporate headquarters in Irvine, California, or can be located remotely within the US.
Key Responsibilities:
Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables.
Manage and oversee development and execution of deliverables including:
Data dissemination – lead continuous updates and dissemination of new clinical data to physicians upon request
Medical information – lead timely response to medical inquiries related to TMTT therapies
Medical education – lead provision of content upon request for continuing medical education
Investigator-initiated studies – oversee process of evaluating and funding of medical research grant requests
Educational grants – oversee process of evaluating and funding of medical education grant requests
Publication support – lead review of externally initiated manuscripts for accuracy of content related to TMTT therapies
Scientific conferences – lead key session identification and provision of medical information to physicians upon request
Health care provider contracts – oversee contracts and payments for medical affairs
Identify risk, develop and lead in the implementation of broad and complex cross-functional Medical Affairs strategies, which may include negotiations with internal and external parties and cross functional teams.
Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams.
Manage operational activities, including process improvements, budgeting, and financial forecasting. Provide regular status updates on budget and deliverables. Formulate go-forward plans based on data analyses.
Create robust talent development plan for the team.
Other incidental duties
Minimum Requirements
Bachelor’s degree with 10 years of medical/scientific experience in clinical affairs, medical affairs, medical information, medical communication, and/or medical education within the medical device or biopharma industries
OR
Master’s degree with 8 years of medical/scientific experience in clinical affairs, medical affairs, medical information, medical communication, and/or medical education within the medical device or biopharma industries
OR
Doctorate degree with 6 years of medical/scientific experience in clinical affairs, medical affairs, medical information, medical communication, and/or medical education within the medical device or biopharma industries
Preferred Qualifications
Clinical knowledge in interventional cardiology is strongly preferred
Knowledge and understanding of compliance, regulatory, and legal policies related to medical affairs activities
Experience adhering to quality and compliance standards in a regulated environment
Understanding of clinical study lifecycle and clinical data dissemination
Customer service orientation and strong verbal and written communication skills
Management of direct report(s)
Additional Skills and General Expectations:
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions, including hire/fire authority and partnering with HR on all aspects of employee relations
Excellent problem-solving, organizational, analytical and critical thinking skills, including high discretion/judgment in decision making
Relationship management skills with ability to drive achievement of objectives
Demonstrated ability to develop external partnerships and drive alignment of objectives
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Proven expertise in Microsoft Office Suite and related tools and systems
Strict attention to detail
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 $128,000 to $181,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).
About Edwards Lifesciences
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 13,000 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.
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.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
Please Note :
www.bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.