We are seeking talented and passionate professionals to join this fast-paced, dynamic team to play a pivotal role in the development of new therapies and devices, from concept through to human use.
The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast paced, dynamic team and play a pivotal role in managing Edwards Lifesciences sponsored clinical studies, bringing new medical devices from concept to commercialization.
As a key member of the Clinical Science, Medical Affairs team, the Associate Manager 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 Associate Manager will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.
Note: This position is internally titled as an Associate Manager, Medical Affairs and is an individual contributor (SME) role.
Essential Job Functions/Key Responsibilities:
* Authors 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 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
* Demonstrated experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
* Strong knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations is highly desirable.
* Experienced with literature reviews and various publication databases including PubMed and Embase.
* Experience working in a cross functional, collaborative environment and is comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.
* 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
* Bachelor's Degree in a related field with 8 years of previous related experience; OR Master's degree with 6 years of related experience; OR PhD with 4 years of related experience working in medical affairs, clinical affairs, and/or clinical science.
* 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.
* Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously
* Excellent oral and written communication skills
Additional Talents and General Expectations:
* 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
For Colorado Residents Only:
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 $129,000 to $151,000
Additional information can be found through the link below:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.