Medical Communications Specialist – Project Manager

Integra LifeSciences

2d•Onsite

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

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, Microsoft Word documents
Capable of managing multiple priorities in fast-paced settings.
EU MDR regulatory knowledge, medical writing, strong attention to detail, proficiency in project management and advanced skills in MS Office, proficiency with Distiller-SR and reference management tools including EndNote and Perfect-It.

Nice To Haves

Master’s degree or PhD in scientific discipline is preferred.

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.