Position Summary

The Medical Writer provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities include authoring Clinical and Medical Affairs documents for various products sold by ICU Medical. Experience in medical, or scientific writing, and/or quality engineering/risk management is preferred, and strong written and verbal communication skills are needed.

Essential Duties & Responsibilities

• Writes and contributes to Clinical and Medical Affairs reporting deliverables including Post-Market Clinical Follow-Up Plans/Reports, Clinical Evaluations and/or Periodic Safety Update Plans/Reports, Regulatory Responses and other related documentation.
• Evaluates and summarizes clinical evidence including but not limited to data from sources such as clinical investigations, literature, post-market surveillance, risk, and Post-Market Clinical Follow-Up activities. Analyzes results in preparation for regulatory submissions and the maintenance of Clinical and Medical Affairs files.
• Collaborates with team members and stakeholders in planning for and supporting reporting related projects and processes.
• Mentors and trains more junior team members.
• Supports additional clinical, regulatory, quality and engineering related deliverables as assigned.
• Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Quality Engineering, Human Factors and clinical experts in completing Clinical and Medical Affairs project related deliverables.
• Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
• Reviews inputs such as IFUs, patient guides, Risk Management files, Clinical Evaluation Reports and Plans (CER/CEP), PMCF Plans and Reports, PMS Plans and PSURs, clinician training materials, and other inputs ensuring alignment of risk information. Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
• Authors and contributes to necessary documents to regulatory submissions and communications, such as regulatory inquiries.

• Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable ICU Medical SOPs.
• Work on special projects as assigned

Knowledge & Skills

• Excellent written and verbal communication skills
• Experience with collaborative, cross-functional teams.
• Excellent analytical skills and ability to manage complex tasks and manage time effectively
• Proficient with Word, Excel, PowerPoint, Outlook, etc.
• High level of attention to detail
• Ability to prioritize key business objectives and respond quickly to changing priorities
• Ability to work independently with minimal daily instruction
• Able to multitask and work in a fast-paced environment

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• High School Diploma required
• Bachelor’s degree from an accredited college or university required, Master’s Degree preferred
• 4+ years work experience required.

Work Environment

• This is largely a sedentary role.

• This job operates in a professional office environment and routinely uses standard office equipment.

• Typically requires travel less than 5% of the time