Senior Specialist, Medical Writing

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you’ll make an impact:

• Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines.
• Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment.
• 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, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports.
• Act as representative in core team meetings in the development of regulatory submissions for EU
• 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

What you'll need (Required):

Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required

What else we look for (Preferred):

• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
• Experienced with literature reviews and various publication databases including PubMed and Embase
• Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations.
• 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

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

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.

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