Senior Specialist, Medical Writing at Edwards Lifesciences
Sr. Specialist, Medical Writing (Remote, USA) Transcatheter Heart Valve (THV)
USA – California – Irvine
USA – Penn – Philadelphia
Remote – North Carolina
USA – Florida – Miami
USA – Washington, District of Columbia
USA – Georgia – Atlanta
Remote – New York City
USA – Illinois – Chicago
USA – Indiana – Indianapolis
USA – Mass – Boston
USA – Michigan – Detroit
USA – Arizona – Phoenix
Remote – Northern California
Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease.
This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting-edge technology. The Transcatheter Heart Valve (THV) team extends Edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis. 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.
The Sr. Specialist Medical Writing will assist with medical writing projects, work with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines.
**This position is remote and can be located anywhere in the United States. **
Responsibilities include, but are not limited to:
- Develop complex medical writing documents/deliverables, and provide input on templates for assigned project(s)
- Responsible for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders
- Conduct literature searches and reviews, including developing a search strategy, manage associated documentation, and prepare literature summaries.
- Act as representative in core team meetings in the development of reporting plans and regulatory submissions (the US and international) for clinical studies
- Lead and provide input on other complex cross-functional deliverables (e.g., risk management review, IFUs, SSED) utilizing technical knowledge
- Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing
- Bachelor’s Degree required Masters degree preferred
- 5 years experience of previous related experience in medical writing
- Experience as a medical writer for a cardiovascular or medical device company
- Formal experience with regulatory medical writing
- 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 proofreading skills
- Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
- 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
- Ability to interact professionally with all organizational levels including internal and external customers
- Ability to manage competing priorities in a fast-paced environment
- Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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 $99,000 to $116,000.
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 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.
Sign up for Daily Remote Job Alerts!