Senior Specialist, Medical Writing

Edwards Lifesciences

. Develop complex medical writing documents/deliverables and provide input on templates for assigned projects .

Posted 10/8/2026full-timeRemote • Mississippi • United StatesSenior💰 $108,000 - $153,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, including the development of complex documents and regulatory submissions, while providing leadership and mentoring to junior writers. Proficient in managing timelines and deliverables across cross-functional teams, with a strong focus on continuous process improvement.

Highest-signal resume keywords

Medical Writing ExpertiseClinical Evaluation Report DevelopmentMicrosoft Office Suite ProficiencyPublication Library Software ExperienceRegulatory Submission Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical WritingClinical Evaluation Report DevelopmentLiterature Search and ReviewRisk Management ReviewScientific Content DevelopmentDocumentation ManagementProcess ImprovementRegulatory Guidelines KnowledgeAttention to DetailAnalytical Skills

Soft Skills

LeadershipCommunication SkillsProblem-SolvingOrganizational SkillsRelationship Management

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointENDNOTEPubMed

Industry Keywords

MEDDEV 2.7/1 REV. 4European Union Medical Device RegulationCross-Functional CollaborationProject ManagementFast-Paced Environment

About the role

Key responsibilities & impact

Develop complex medical writing documents/deliverables and provide input on templates for assigned projects
Serve as the lead for negotiating deliverables and timelines and resolving project-related issues with cross-functional stakeholders
Conduct literature searches and reviews, including developing search strategies, managing associated documentation, and preparing literature summaries
Represent the team in core meetings for reporting plans and regulatory submissions for clinical studies in the US, EU, and internationally
Lead and contribute to complex cross-functional deliverables, including risk management reviews, IFUs, and SSEDs
Provide leadership, training, guidance, and mentoring to less experienced medical writers
Identify, recommend, and assist with implementing continuous medical-writing process improvements
Act as primary contact for medical writing projects and coordinate internal and external deliverable timelines with Edwards departments and clients

Requirements

What you’ll need

Bachelor's Degree in related field with 5 years of previous related experience in medical writing or equivalent work experience based on Edwards criteria
Experience with clinical evaluation report (CER) development under MEDDEV 2.7/1 REV. 4 and/or the European Union Medical Device Regulation (EU MDR)
Proven expertise in Microsoft Office Suite, including Word, Excel and PowerPoint
Experience with publication library software (e.g., ENDNOTE) and database systems (e.g., PubMed)
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 and 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 projects

Benefits

Comp & perks

Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of employees and their families