Associate Manager Medical Communication
Integra LifeSciences · US
Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare.
Job description
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. KEY RESPONSIBILITIES: - Prepares complex clinical and regulatory deliverables in accordance with internal GSOPs and applicable regulatory guidelines with minimal oversight. - Authors clinical documentation including Literature Review Protocols and Reports, Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance, and Post-Market Clinical Follow-Up Plans and Reports. - Develops additional deliverables such as clinical study reports, investigator brochures, manuscripts, posters, abstracts, publication plans, and internal white papers. - Performs and documents methodologically sound literature searches and critically evaluates peer-reviewed clinical data. - Maintains compliance with European, Australian, Canadian, and U.S. medical device regulatory requirements. - Partn...