Senior Specialist, Medical Writing
$108k - $153kEdwards Lifesciences Corp.
Edwards Lifesciences seeks a Senior Specialist in Medical Writing to lead clinical evidence documentation and regulatory submissions for transcatheter heart valve technologies. The role involves developing complex medical documents, managing cross-functional projects, and mentoring junior writers within the Clinical Affairs team.
Responsibilities
- Develop complex medical writing documents and project templates for assigned initiatives
- Lead negotiation of deliverables and timelines with cross-functional stakeholders
- Conduct literature searches and reviews with comprehensive documentation and summaries
- Represent team in meetings developing reporting plans and regulatory submissions
- Mentor and provide guidance to less experienced medical writers on technical matters
Requirements
- Bachelor's degree in related field with 5+ years medical writing experience
- Experience with clinical evaluation reports under MEDDEV 2.7/1 REV. 4 or EU MDR
- Proficiency in Microsoft Office Suite and publication/database software
- Excellent written and verbal communication with negotiation skills
- Strong leadership, analytical, and critical thinking abilities
- Knowledge of scientific content development policies and regulatory guidelines
- Ability to manage competing priorities in fast-paced environments
Compensation: $108,000-$153,000 base
Vacancy posted 2 days ago
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