On-site, Full-time, Mid-Senior level
Position Summary
The Medical Writer II 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.
This is a hybrid position and can be based out of our Plymouth, MN, Salt Lake City, UT or Lake Forest, IL locations.
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 any combination of these skills.
- CER writing experience strongly preferred
- Literature search experience is preferred
- Biomedical sciences, medicine or similar health related discipline preferred
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Medical
Primary Location
US-MN-Plymouth
Other Locations
US-IL-Lake Forest, US-UT-Salt Lake City
Schedule
Full-time
Shift
Day Job
I am a pharmacist, community pharmacy consultant, and medical writer with over 12 years of clinical practice experience in community, outpatient health system, long term care, and academic settings. I am also the founder of PharmCompliance.com, a website dedicated to the success of community pharmacy.
As a pharmacy project manager, I led the implementation of new service lines, assist with ensuring legal and third-party compliance for over 70 retail stores, lead quality improvement and medication safety initiatives, write policies, procedures, and best practices for all our retail sites, and help with optimizing revenue cycle and pharmacy profitability. I have been responsible for DMEPOS and vaccine accreditation through CMS, obtaining new licenses and permits, and implementing a prescription drug kiosk embedded in our physician offices.
As a medical writer, my work has been featured in GoodRx, Pharmacy Times, Drug Topics, Patient Care Online, and in peer-reviewed journals. I have also given presentations on a range of topics, from disease state pharmacotherapy for medical residents to updates on the CDC vaccine storage and handling guidelines for a medical-grade refrigerator and freezer manufacturer. I have written and presented continuing education for CEImpact, FreeCE, AchieveCE, Ascension Health, and the Florida Department of Health.
