RN Specialist at Advocate Health ensuring accurate clinical documentation and coding compliance. Collaborating with healthcare teams to improve patient record quality and completeness.
About the role
- Lead Medical Writer responsible for advanced writing projects including clinical study reports and protocols at IQVIA. Collaborating across teams to meet client requirements with adherence to timelines.
Responsibilities
- Acts as Lead Medical Writer on more advanced writing projects
- Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines.
- May provide feedback to peers when asked for input or review.
- Negotiates timelines and discusses/resolves customer comments.
- Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP)
- Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
- Manage day-to-day workload: identify project needs, track timelines and implement customer requests, keeping manager/senior staff abreast of progress on tasks and any potential problems with project work.
- Lead customer meetings independently.
- May give presentation to an existing customer (e.g. to discuss templates, results, lessons learned), responding appropriately to feedback.
- May deliver basic level training to small groups or individuals within IQVIA on the role of the medical writer, on medical writing processes, or on specific customer templates/processes.
- May also provide guidance to more junior colleagues.
- May take the role of Project Manager for a small and short Medical Writing project.
- Complete project finance activities, including monitoring and forecasting budgeted hours.
- Understand budgets and project finance principles. Interact with Project Leader/Project Finance Manager directly regarding straightforward financial issues, increasing ability to estimate hours needed for more straightforward/routine tasks.
- May propose revisions to standard operating procedures (SOPs) or suggest process improvements for consideration.
Requirements
- Bachelor's Degree in life sciences related discipline or related field
- Master's Degree in life sciences related discipline or related field (Preferred)
- Ph.D. in life sciences related discipline or related field (Preferred)
- Typically requires at least 3 years of prior relevant experience and related competency levels.
- Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.
- Ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
- Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
- Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output.
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
- Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues.
- In depth knowledge of drug development, medical writing, and associated regulations.
Benefits
- Health insurance
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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