Position Summary
JOB DESCRIPTION
The Medical Writer provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities include authoring Clinical Evaluation Reporting documents for the infusion therapy consumables, infusion pumps, infusion therapy software, and critical care products. Experience in medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed.
Essential Duties & Responsibilities
- Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, Regulatory Responses and other related documentation.
- Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for regulatory submissions and the maintenance of clinical evaluation report files.
- Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes.
- 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, and Medical Affairs in completing clinical evaluation 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 IFUs, patient guides, Risk Management files, Clinical Evaluation Reports and Plans (CER/CEP), clinician training materials, 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.
Knowledge, Skills & Qualifications
- 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
Education And Experience
- Bachelor’s Degree required in related field
- Minimum of 2 years medical writing experience in the medical or pharmaceutical industry or 5 years general technical writing experience required
- Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills
- CER writing experience strongly preferred
- Literature search experience is preferred
- Biomedical, sciences, medicine or similar health related discipline preferred
Travel Requirements
- Typically requires travel less than 5% of the time
Physical Requirements And Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
About Us
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement:
ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.
ICU Medical EEO Policy Statement
OFCCP Equal Opportunity Posters
“Know Your Rights” Poster
Pay Transparency Nondiscrimination Provision
ICU Medical CCPA Notice to Job Applicants
