Medical Communications Specialist – Project Manager
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Job Description
Medical Communications Specialist editing and managing medical writing deliverables in healthcare. Collaborating with project managers and stakeholders for effective communication and compliance with regulations.
Responsibilities:
- Edits medical writing deliverables as required
- Manages medical writing referencing and literature software and problem solves team issues coordinating with IT and software developers
- Supervises project tracking systems, timelines, deliverables, dashboards, and workflow processes
- Collaborates with project managers and facilitates effective communication between EU MDR stakeholders and project teams
- Oversees secure document storage and retrieval within designated systems
- Ensures adherence to industry standards, organizational policies, and medical device regulations
- Leads team meetings by setting agendas, monitoring action items, and disseminating meeting notes and resources across the Medical Communications team
- Manages vendor relationships to maximize project deliverables and optimize outcomes
- Maintains version control and organization of medical communication documents and files
- Manages departmental procedures and documentation, ensures compliance with clinical, regulatory, and quality requirements
- Updates and monitors Global Standard Operating Procedures and support preparation for Change Review Board evaluations
- Administers document management on company intranet and route materials for signature approvals
- Monitors project risks and assess stakeholder needs to ensure alignment with departmental objectives
Requirements:
- Bachelor’s degree in scientific or healthcare discipline or equivalent experience in similar role is required
- Minimum of 2 years’ experience in medical writing focused on clinical evaluations and PMCF with experience in editing and formatting
- Capable of managing multiple priorities in fast-paced settings
- EU MDR regulatory knowledge
- medical writing
- strong attention to detail
- proficiency in project management
- advanced skills in MS Office
- proficiency with Distiller-SR and reference management tools including EndNote and Perfect-It.
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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