A Medical Writer applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe the research results, product use, and other medical information. Medical writers may also offer writing support to the principal investigators for grant applications and specialized publications.
Either Full or Part Time, more than 6 months
SR You may contact this employer directly.
(Obtain the contact information to print or add to your jobs.) Obtain Contact Information
Job Summary USA - California - Irvine #
LI-REMOTE
Full time Req-50045 Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Specialist, Medical Writing will act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. How you'll make an impact: Develop complex medical writing documents/deliverables and provide input on templates for assigned project(s) Serve as the lead for negotiating deliverables and timelines and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, and preparing literature summaries. Act as representative in core team meetings in the development of reporting plans and regulatory submissions (US, EU, and international) for clinical studies Lead and provide input on other complex cross-functional deliverables (e.g., risk management review, IFU, SSED) utilizing technical knowledge Provide leadership, training, and guidance and act as a mentor to less experienced medical writers Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing What you'll need (Required): Bachelor's Degree in related field with 5 years of previous related experience in medical writing or equivalent work experience based on Edwards criteria What else we look for (Preferred): Graduate degree (e.g., MS PhD) in life science, engineering, or related field Experience with clinical evaluation report (CER) development under
MEDDEV 2.7/1 REV.
4 and/or the European Union Medical Device Regulation (EU MDR) Proven expertise in Microsoft Office Suite, including Word, Excel and PowerPoint, and publication library software (e.g., ENDNOTE) and database systems (e.g., PubMed) Excellent written and verbal communication skills, including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical, and critical thinking skills Full knowledge and understanding of policies, procedures, and guidelines related to the development of scientific content and medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage com... Technical Writers
Access our Statewide and Regional occupation report for more information about wages, employment outlooks, skills, training programs, related occupations, and more.
Compensation
Not Provided
Job Requirements
