Job Responsibilities:
• This individual will primarily support Medical Affairs in the coordination of Clinical Evaluation Reports (CER) across DePuy Synthes. This may entail scheduling CER Review meetings, tracking CER timelines, vendor management, and tracking literature search requests to ensure CER timelines are met.
• Business Leadership
• Ensure that safety and efficacy of our products are documented, processed, and reported following Company guidelines, internal business practices, and regulatory guidance to ensure compliance with worldwide safety regulations and corporate policies.
• Administrative Leadership
• Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance.
Education
• BS in Life Sciences, PMP preferred
Knowledge/Requirements
• This is an entry level position
• Broad knowledge of medical device clinical and regulatory requirements is preferred.
Additional Requirements
• Strong skills and demonstrated competencies in the following areas are required:
o Verbal and written communication skills
o Proven ability to multi-task
o Effective time management skills
o Strong organizational skills
o Proficiency with the Microsoft Office suite
o Medical writing and presentation skills
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.