Part Time – Clinical Documentation Integrity Specialist, CDIS
firsthand
Senior Clinical Medical Writer
Diabetes Youth Families
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $101,925 - $152,887 per year
Job Level
Senior
About the role
- Write documents, including complex submission-level clinical documents, to be included in registration files by interpreting clinical data clearly, accurately, and concisely and within the designated timelines.
- Author clinical documents such as clinical study protocols and reports, summary reports, study synopses, and investigator brochures.
- Create and maintain regulatory documents related to clinical data (CEP, CER, PMCF, Annual Reports, etc.) in liaison with other departments in compliance with applicable regulatory requirements.
- Acquire knowledge of therapeutic areas, competitor devices, and current clinical/market developments.
- Ensure the consistency and quality of all documents that are issued.
- Plan and execute structured literature searches and identify and analyze relevant clinical data.
- Review the literature and interpret and summarize risks, alternative therapies, and device-specific benefits. Appraise scientific literature and write clinical summaries for products.
- Perform other tasks as required.
Requirements
- Master’s degree in life sciences and 3+ years of medical writing experience at a medical device, biotechnology or contract research organization; or BS degree with 5+ years of experience
- Understanding of world-wide clinical related regulations and guidance documents.
- Expertise in MS Word, Excel and PowerPoint.
- Demonstrated analytical skills and interpretation of clinical data.
- Excellent verbal and written communication skills.
- Strong attention to detail and exceptional follow-through.
- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
- Ability to work and excel within a fast-paced, dynamic, and continuously changing work environment.
- Solid project management and organizational skills with the capacity to prioritize and multi-task.
Benefits
- 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingclinical study protocolsregulatory documentsliterature searchesclinical data interpretationanalytical skillsproject managementattention to detail
Soft skills
verbal communicationwritten communicationorganizational skillsprofessional interactionproblem escalationadaptabilitymulti-tasking
Certifications
Master’s degree in life sciencesBachelor’s degree in life sciences
