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Edwards Lifesciences Senior Specialist, Medical Writing (Remote, USA), Transcatheter Heart Valve in Kansas

Senior Specialist, Medical Writing (Remote, USA), Transcatheter Heart Valve

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring, with a rapidly growing portfolio of innovative and less invasive solutions.

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.

We have an outstanding, rewarding opportunity for you to join the THV Clinical Affairs team as a Sr Specialist, Medical Writing. Acting as primary contact for medical writing projects, and working with other cross-functional Edwards departments, you will provide guidance, develop, and lead medical writing projects, timelines and activities.

Key Responsibilities:

  • 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 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

  • 10% travel

Minimum Requirements

  • Bachelor's Degree in a related field and 5 years of related experience in medical writing

  • Master's Degree in a related field and 3 years of related experience in medical writing

Preferred Qualifications

  • Cardiovascular medical device experience

  • Experience writing FDA PMA applications, IDE Progress Reports and documents for PMA post approval requirements;

  • Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements

  • Medical writing experience specific to regulations within regulatory affairs scope, in medical device

Additional Skills and General Expectations:

  • 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

  • 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

  • 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 company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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

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.

For Colorado, the base pay range for this position is $119,000 to $139,000 (highly experienced).

For New York City, the base pay range for this position is $126,000 to $146,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Additional information can be found through the link below:

https://www.edwards.com/careers/benefits

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

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, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

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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