Associate Manager – Medical Communication
Integra LifeSciences
full-time
Posted on:
Location Type: Office
Location: United States
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Salary
💰 $82,000 - $113,000 per year
About the role
- 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
- Partners with subject matter experts and external vendors to develop technical content that meets regulatory and business needs
- Mentors junior staff and helps develop templates, tools, SOPs, and best practices
Requirements
- Bachelor’s degree (BA/BS) required; advanced degree (PhD or PharmD) preferred
- Minimum of 8 years of industry experience (5 years with PhD/PharmD)
- At least 5 years as a medical writer
- Advanced medical writing
- Regulatory knowledge
- Project management
- Strong attention to detail
- Proficiency with MS Office and reference management tools
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- savings plan (401(k))
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical documentationliterature review protocolsclinical evaluation plansclinical evaluation reportsclinical study reportsinvestigator brochuresmanuscriptspost-market clinical follow-up plansregulatory knowledgeadvanced medical writing
Soft Skills
attention to detailmentoringproject management
Certifications
Bachelor’s degreePhDPharmD