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.
How you'll make an impact...
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 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.
What you’ll need (Required):
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.
What else we look for (preferred):
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.
#J-18808-Ljbffr
