Edwards Lifesciences Specialist, Medical Writing - Transcatheter Mitral and Tricuspid Therapies in Irvine, California
This is a unique opportunity to play a critical role in the growth of new cutting-edge heart valve therapies for Mitral & Tricuspid Valve Repair and Mitral Valve Replacement.
This team member will contribute to providing scientific expertise throughout the development and implementation of clinical evaluations including but not limited to Clinical, Scientific, and Regulatory documents and presentations for Regulatory submissions, reports, responses, and internal and external meetings.
As a key member of the Medical Affairs, Clinical Science & Biometrics team, this individual will provide scientific expertise in the development of clinical trial strategy, clinical study design, clinical evaluation reports, clinical study protocols, clinical study reports, risk management, and /or clinical studies in alignment with the TMTT business strategy. Through extensive interaction with clinician thought leaders (KOLs) along with a strong diverse cross-functional leadership team within the organization, this individual will have opportunities to make strategic and scientific impact on our current and future clinical portfolio.
Authors clinical evaluation plans (CEP), clinical evaluation reports (CERs), clinical trial protocols (pre- and post-market), Clinical Study Reports, Annual Progress Reports (APRs) and other scientific documents (as appropriate).
Partner with TMTT R&D, Clinical Affairs, Safety, Regulatory Affairs, QA, Biometrics, GHER 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
Maintain current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
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
Independently review raw and summary data for accuracy.
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.
Education and Minimum Requirements:
A Bachelor's degree in a relevant field with 5 years of previous medical writing and clinical data analysis experience in the medical device field is required, or a Master's degree with 3 years, or a PhD with 2 years’ experience is required;
Relevant experience supporting class III cardiovascular medical devices
Additional Talents and General Expectations:
Must be familiar with the coronary interventional and structure heart environments and current treatment options or have other clinical and/or clinical trial experience that fulfills this requirement.
Must have a good understanding of US FDA, MDR, Good Clinical Practice requirements and ICH guidelines.
Experienced with literature reviews and various publication databases including PubMed.
Strong analytical, problem-solving, and scientific writing skills.
Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously.
Moderate knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques
Excellent oral and written communication skills
Develops solutions to a variety of problems of moderate scope and complexity
Contributes to process improvements
Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote and Adobe Acrobat
He/she must be assertive, persistent, detail- oriented, and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.
Ability to interact professionally with all organizational levels and functions where appropriate
Ability to manage competing priorities in a fast paced environment
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.