Director of content for Fidelity’s retail clients, focusing on advanced trading and investing strategies. Collaborating with investment experts to create actionable content for engaged investors.
About the role
- Medical Writing Specialist developing regulatory documentation for medical communications. Collaborating closely with cross-functional teams and ensuring compliance with EU and FDA standards.
Responsibilities
- Edit, review, and format medical writing deliverables to ensure scientific accuracy, clarity, consistency, and regulatory compliance
- Support Clinical Evaluation Reports (CERs), PMCF plans, PMCF evaluation reports, clinical summaries, and related regulatory documentation in alignment with EU MDR requirements
- Maintain project trackers, timelines, deliverables, dashboards, and workflow tools to support department operations
- Coordinate with cross-functional stakeholders to support post-market clinical follow-up activities and document updates
- Manage reference libraries and literature management tools; coordinate issue resolution with IT and software vendors as needed
- Ensure secure storage, retrieval, version control, and inspection readiness of medical communications documentation
- Support vendor coordination to ensure timely, high-quality document deliverables
- Prepare meeting agendas, track action items, and distribute meeting notes and resources
- Ensure departmental procedures and documentation comply with applicable clinical, regulatory, and quality requirements
- Update and track global standard operating procedures and support Change Review Board preparation activities
- Monitor project risks and stakeholder needs to ensure alignment with departmental objectives
Requirements
- Master’s degree or PhD in scientific discipline is preferred
- Bachelor’s degree in scientific or healthcare discipline may be considered with six years of experience
- Minimum 2 years of writing experience in the medical device or pharmaceutical industry
- Experience with systematic literature reviews, writing literature protocols and literature reports
- Ability to produce clinical evaluation plans/reports with minimal oversight
- Strong technical writing skills
- Bibliographic research and editorial skills
- Ability to interpret and disseminate relevant product information
- Proficiency in MS Office applications
- Proficiency in EndNote or Reference Manager
- Basic understanding of regulatory compliance for medical devices
- Maintains general knowledge of industry, regulatory, marketing, linguistic, and publication standards
- Strong organizational skills, attention to detail and proofreading skills
- Working knowledge of EU MDR clinical evaluation and post-market clinical follow-up requirements
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- savings plan (401(k))
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