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The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.We have an outstanding, rewarding opportunity for you to join Edwards as an Associate Manager, Medical Writer . You will provide guidance, develop, and lead medical writing projects, timelines and activities.This position is remote and can be located anywhere in the United States.Responsibilities include, but not limited to:Plan, develop and lead the completion of complex medical writing projects in a fast-paced environment with accountability for successful completion within scope of project deliverables including negotiating deliverable timelines, and resolving project-related issues with cross-functional partners (e.g., Regulatory Affairs, Quality, Clinical Project Managers, Clinical Data Management, Biostatistics, etc.)
Act as a technical expert to key stakeholders to develop and lead the implementation of corporate, business unit, and departmental process updates and improvements (e.g., MDR compliance, etc)
Provide direction and guidance for smaller projects to execute medical writing projects and/or initiatives.
Provide mentoring and knowledge transfer for Medical Writing team members
Act as a representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies
Minimum Requirements:Bachelor's Degree in related field with 8 years of related scientific experience OR Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) in related field with 6 years of related scientific experience;
Experience as a medical writer
Experience with CERs (Clinical Evaluation Reports) - EU preferred
Preferred Qualifications:Demonstrated ability to discuss complex scientific and technical subjects with stakeholders
Demonstrated ability to provide leadership and guidance; skilled in coaching and training techniques
Proven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote) and database systems (e.g., Medline or PubMed)
Extensive editing and prooing skills
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Experience with PMAs (Pre Market Approvals) - FDA
Experience as a medical writer for cardiovascular or medical device company preferred
Additional Talents and General Expectations:Lead the identification, recommendation and implementation of continuous process improvements as it relates to medical writing
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 $117 000 to $137 000.Additional information can be found through the link below:https://www.edwards.com/careers/benefitsEdwards 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.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 15,000 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.
Full-time