Edwards Lifesciences Senior Specialist, Medical Writing (Remote, USA) Transcatheter Heart Valve (THV) in North Carolina
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 Sr Specialist, 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.
Develop complex medical writing documents/deliverables, and provide input on templates for assigned project(s)
Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders
Conduct literature searches and reviews, including developing search strategy, manage associated documentation, and prepare literature summaries
Act as Scientific Communications representative in core team meetings in the development of reporting plans and regulatory submissions (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
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
Other incidental duties assigned by Leadership
Education and Experience:
Bachelor's Degree in Science or related field plus 5 years experience; OR Master's Degree in Science or related field plus 3 years experience required
Medical writing experience specific to regulations within regulatory affairs scope, in medical device, strongly preferred
Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements strongly preferred
Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
Excellent written and verbal communication skills, in English language, 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
Full knowledge of medical writing
Good leadership skills and ability to influence change
Strict attention to detail
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
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
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.
Additional information can be found through the link below:
Edwards 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 Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, 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.
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