Associate Manager, Medical Affairs - Transcatheter Mitral & Tricuspid Therapies

Edwards Lifesciences Corp Irvine , CA 92606

Posted 7 months ago

The Associate Manager, Clinical Science / 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.

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, 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.

The Associate Manager will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.

Key Responsibilities:

  • Authors clinical evaluation plans (CEP), clinical evaluation reports (CERs), clinical trial protocols (pre- and post-market) 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.

#LI-JB1

#MI

Education & Experience:

  • Bachelor's Degree in a related field with 8 years of previous clinical science experience, a Master's degree with 6 years, or a PhD with 4 years, preferably within the medical device industry

  • 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 an understanding of 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

  • Excellent oral and written communication skills

  • 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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Engineering CoOp Transcatheter Mitral And Tricuspid Therapies

Edwards Lifesciences Corp

Posted 2 days ago

VIEW JOBS 10/22/2019 12:00:00 AM 2020-01-20T00:00 This Co-Op position is a full-time position working as a Clinical Development Engineer in the cutting-edge medical device field with a focus on devices and therapies to treat mitral valve disease. This is a hands-on position where the student will work closely as a part of the Clinical Development engineering team to develop, test, and implement designs pertaining to advanced Transcatheter technology to address issues caused by structural heart disease. The Co-Op engineer will have the opportunity to develop design skills and act as an integral and contributing member of the development team. Students will design and test new concepts and contribute to the development of innovative medical devices to help improve the quality of life of patients suffering from varying forms of heart failure. The Co-op engineer will report to senior level engineers and will be required to report on daily tasks and activities. ROLE EXPECTATIONS The Co-Op Engineer will: * Be timely, punctual, and responsible for day-to-day attendance while proactively seeking direction from senior engineers. * Conceptualize, develop, and iterate designs in response to design requirements specified. * Test new designs (functional testing, mechanical testing, and simulated use) and brainstorm novel ideas for device improvements using test results. * Assist in documenting production department concerns and aid in troubleshooting and resolving technical problems. * Be proficient in drafting software (Solidworks or Creo Parametric preferred). * Provide documentation support and complete written reports on testing and designs. * Actively participate in design reviews and provide relevant feedback for teammates. LOCATION Program participants will work in our corporate headquarters in Irvine, California. Please visit Edwards.com for information on all of our locations. #LI-DNI REQUIREMENTS To qualify for Co-Op opportunities, the candidate must be: * Currently enrolled as a student for the duration of the Co-Op project (MUST be able to work full-time from January 2020– August 2020). Junior or Senior standing preferred, pursuing degree in Biomedical Engineering, Mechanical Engineering, Bio-engineering etc. Course competition of engineering mechanics and mechanical design is preferred. * Comfortable working in laboratory environment. Hands-on and highly motivated. Able to follow procedures, perform testing and clearly convey data results. * Strong interest in pursuing relevant industry experience. Interest in the healthcare and medical devices industry is a plus. * Proficient in drafting software. Solidworks or Creo Parametric Preferred. * Must be in good scholastic standing (3.0 GPA or equivalent). * U.S. citizenship or permanent residency is required; some exceptions will apply. HOW TO APPLY Submit your resume to our Co-Op opportunities listed on www.edwards.com/careers/jobs. Our Co-Op recruitment period is from September through November 2019. Specific Co-Op projects will be identified during this time and qualified candidates will be contacted for further discussion and preliminary phone interviews. Selected candidates may be asked to travel to the Edwards Campus in Irvine, California for formal onsite interviews and final selection. The timeframe for this Co-Op is from January 2020 to August 2020. Edwards Lifesciences Corp Irvine CA

Associate Manager, Medical Affairs - Transcatheter Mitral & Tricuspid Therapies

Edwards Lifesciences Corp