CytoSorbents
Published
May 13, 2021
Location
Princeton, NJ
Job Type
Work Setting
Remote / Home-based, In-office

Description

Description

CytoSorbents, a critical care leader specializing in blood purification to treat deadly conditions in critically ill and cardiac surgery patients, is seeking a Medical Writer to collaborate with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines. Come join us in saving lives!

Responsibilities

  • Preparing, editing, and finalizing protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts
  • Creating slide master template for clinical team presentations and creating a library with the clinical decks
  • Actively participating in the development of the strategic clinical/medical communication plans
  • Partnering with the study biostatistician to prepare and review mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
  • Working closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources
  • Collaborating with the clinical team to interpret study results and ensure interpretations are accurately and clearly reflected in relevant documents
  • Scheduling and conducting document-related meetings including preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
  • Managing the document review process and version control while ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
  • Collaborating with the clinical team to complete all documents according to internal or external timelines
  • Ensuring that medical writing outputs conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
  • Creating, curating and overseeing the clinical team’s document management system
  • Performing document quality control (QC) checks and recommending quality process improvements
  • Suggesting modifications to document preparation processes & templates to improve quality and efficiency
Requirements
  • Bachelor’s degree in medical-related field or life science. Post-graduate degree preferred
  • 5+ years of relevant medical writing experience
  • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
  • Experience in interacting with cross functional study team members
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
  • Experience working independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
  • Read, write and speak fluent English; excellent verbal and written communication skills
Apply
https://www.linkedin.com/in/your_name/
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