[Hiring] Associate Manager Medical Communication @Integra LifeSciences

Role 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.

• 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.

Qualifications

• Education: Bachelor’s degree (BA/BS) required; advanced degree (PhD or PharmD) preferred.
• Experience: Minimum of 8 years of industry experience (5 years with PhD/PharmD); at least 5 years as a medical writer.
• Skills: Advanced medical writing, regulatory knowledge, project management, strong attention to detail, and proficiency with MS Office and reference management tools.

Requirements

• Ability to sit and work at a computer for extended periods with visual acuity for detailed document review.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Savings plan (401(k)).
• In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.