Senior Specialist, Medical Writing

Senior Specialist, Medical Writing – Edwards Lifesciences

Dedicated to innovation, our Surgical business unit focuses on identifying and solving critical, unmet needs in cardiac surgery. We partner with surgical teams to deliver modern technologies that enhance patients’ quality of life and expand treatment opportunities. Join us and be part of our inspiring journey.

• Act as primary contact for medical writing projects, working with 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/reports, 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, develop search strategy, manage associated documentation, extract relevant data, and write clear and concise summaries to support clinical evaluation reports.
• Represent the team in core meetings for regulatory submissions for the EU.
• Provide leadership, training, and guidance; act as a mentor to less experienced medical writers.
• Identify, recommend, and assist in the implementation of continuous process improvements related to medical writing.
• Perform other incidental duties assigned by Leadership.

Required

• Bachelor’s Degree in a related field.
• 5 years of medical writing experience or equivalent work experience based on Edwards criteria.

Preferred

• Proven expertise in Microsoft Office Suite (Word, PowerPoint, Access, Excel).
• Experience with literature reviews and publication databases (Pub Med, Embase).
• Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations.
• Excellent written and verbal communication, customer negotiation, and relationship management skills.
• Strong problem‑solving, organizational, analytical, and critical‑thinking skills.
• Knowledge of policies, procedures, and guidelines for scientific content development.
• Full knowledge of medical writing best practices.
• Leadership skills and ability to influence change.
• Strict attention to detail.
• Professional interaction with all organizational levels.
• Ability to manage competing priorities in a fast‑paced environment.
• Teamwork and collaboration across inter‑departmental teams and external contacts.
• Adherence to all company rules and requirements.

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

All patient‑facing and in‑hospital positions require COVID‑19 vaccination. If hired into a covered role, a proof of vaccination must be submitted unless a medical or religious accommodation is granted. This requirement does not apply where prohibited by law.

Not Applicable

Full‑time

Health Care Provider

Medical Equipment Manufacturing