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Associate Manager – Medical Communication
Integra LifeSciencesAssociate Manager Medical Communication preparing clinical and regulatory documents for medical technology firm. Ensuring compliance with medical device regulatory requirements and mentoring junior staff.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- savings plan (401(k))
ATS Keywords
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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