Senior Specialist, Medical Writing

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Dedicated to innovation, our Surgical business unit focuses on identifying and solving critical unmet needs in cardiac surgery. By collaborating with surgical teams, we deliver modern technologies to enhance patient quality of life and expand treatment options.

• 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 and deliverables such as clinical evaluation plans, post‑market clinical follow‑up plans, 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 strategies, managing associated documentation, extracting relevant data, and writing clear, concise summaries to support the development of clinical evaluation reports.
• Represent in core team meetings in the development of regulatory submissions for the EU.
• Provide leadership, training, and guidance and mentor less experienced medical writers.
• Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing.
• Perform other incidental duties assigned by leadership.

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

• Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel.
• Experience with literature reviews and various publication databases including Pub Med 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 contacts representing the organization on contracts or projects.
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
• Adherence 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 protecting the environment and preventing 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 vulnerable patients and healthcare providers. As such, all patient‑facing and in‑hospital positions require COVID‑19 vaccination. If hired into a covered role, a condition of employment is the submission of proof of vaccination unless a medical or religious accommodation is granted. This requirement does not apply in locations where it is prohibited by law to impose vaccination.