Senior Medical Writer, Scientific Communication, Critical Care Hemodynamic Portfolio

31 Mar 2024

Vacancy expired!

Senior Medical Writer, Scientific Communication, Critical Care Hemodynamic PortfolioEdwards 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.This is an exceptional opportunity to join the Critical Care group, focused on advancing hemodynamic monitoring solutions and improving the quality and efficiency of care. With over 50 years of technological advances, Edwards’ Critical Care group continues to lead in this space by delivering cutting edge products that are powered with machine learning; evolving to less-invasive, and noninvasive devices; refining hemodynamic monitoring platforms; and providing evidence-based programs to enable proactive clinical decisions for surgical, anesthesia and critical care clinicians. Our products are used by millions of patients each year in over 80 countries around the world.The Senior Medical Writer, Scientific Communication (internally titled Senior Specialist, Medical Writing) will act as primary contact for medical writing projects, and work with other cross-functional Edwards departments to provide guidance, develop, and lead medical writing projects, timelines and activities.This role will be located at Edwards’ corporate headquarters in Irvine, California.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 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

Minimum Requirements:

Bachelor's Degree in related field and 5 years of previous related experience in medical writing; OR Master's Degree in related field and 3 years of previous related experience in medical writing;

Preferred Qualifications:

Familiarity with monitoring technologies in anesthesia/critical care settings

Experience as an author or contributor for peer-reviewed manuscripts

Experience with literature search and summaries

Experience resolving internal literature inquiries

Experience as a medical writer for pharmaceutical, Contract Research Organization (CRO), or medical device clients

Experience with cross-functional collaboration with R&D, Regulatory, Marketing and Compliance.

Additional Skills and General Expectations:

Good computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote)

Good editing and prooing skills

Good written and verbal communication skills including negotiating and relationship management skills

Good problem-solving and critical thinking skills

Moderate knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques

Moderate knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)

Moderate knowledge of statistics

Strict attention to detail

Ability to interact professionally with all organizational levels and functions where appropriate

Ability to manage competing priorities in a fast paced environment

Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

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

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 $101,000 to $142,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.

Full-time
  • ID: #49600973
  • State: California Irvine 92602 Irvine USA
  • City: Irvine
  • Salary: USD TBD TBD
  • Showed: 2023-03-31
  • Deadline: 2023-05-31
  • Category: Et cetera