Medical Writer III

Cardinal Health • Juneau, AK

420d • $93,500 - $133,600

About The Position

The Medical Writer III at Cardinal Health is a key member of the Medical Segment Clinical Affairs team, responsible for researching, creating, editing, and coordinating the production of clinical documents, particularly Clinical Evaluation Reports (CERs) and Post Market Surveillance Plans. This role requires a thorough understanding of medical writing, project management, and European medical device regulations, ensuring high-quality documentation to support CE marked devices.

Requirements

• Bachelor's degree in a relevant discipline required; Master's degree or PhD preferred
• Minimum 2 years of medical writing experience preferred
• Proven experience performing literature reviews and analyzing data
• Experience in a medical device or pharmaceutical organization in relevant roles
• Experience presenting scientific/clinical evidence to cross-functional teams
• Demonstrated ability to build positive relationships with team members
• High level of personal integrity and emotional intelligence
• Knowledge of MDD, MDR, and MEDDEV requirements
• Proficient scientific writing skills
• Experience using literature search tools like Embase, PubMed, and Google Scholar
• Strong data extraction and analysis skills
• Self-motivated and able to work independently
• Analytical thinking and inquisitive mindset

Responsibilities

• Write clinical evaluation reports (CERs) and post market surveillance summaries
• Perform gap assessments of clinical documents for devices to ensure compliance with regulatory requirements
• Work with internal teams to gain cross-functional inputs and approvals
• Support periodic and ad hoc assessments of device safety and efficacy
• Develop and manage CER project plans and timelines
• Plan and deliver intra-departmental and cross-functional communication
• Perform comprehensive literature searches to support assigned product lines
• Apply global regulations and guidelines, as well as Cardinal Health policies and procedures
• Assist in the development of processes and maintain compliance documentation

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before payday with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree