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#Medical writer jobs dallas tx trial

Ensure that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines.Manage the document review process ensuring conflicting and/or ambiguous comments are appropriately addressed while keeping appropriate version control.When appropriate and relevant, collaborate with medical directors, clinical research scientists and biostatisticians to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents.Schedule and conduct document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes.Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and narrative planning for relevant documents.Partner with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents.Participate in scientific communication planning if relevant in coordination with the publication team that is part of medical affairs.

Collaborate with Clinical Development leadership and cross functionally to prepare, edit and finalize standard operating procedures and standardized templates for the Clinical Development Department.

Collaborate with members of cross-functional teams to prepare, edit, and finalize high-quality core clinical documents including but not limited protocols, investigator brochures, synopses, regulatory documents, clinical safety reports, and related clinical documents within agreed-upon timelines.

This is a full-time, exempt, field-based role reporting to the Senior Manager, Clinical Research Scientist. In addition to producing content for clinical documents and safety reports, the employee would also create content for conferences or presentations on behalf of Clinical Development study teams.This role will allow the employee to support the novel technology of TTfields that has potential to shift the treatment paradigm as one of the few therapeutic device modalites in oncology. The ideal candidate is someone who can convey scientific data and clinical research results in a clear, concise manner working in a multi-disciplinary with regulatory, clinical operations and other functions as necessary to support high quality core clinical document production including annual safety reports.

#Medical writer jobs dallas tx trial

The Medical Writer is part of Global Clinical Development supporting conduct of clinical trial programs comprised of several pilot and pivotal trials in thoracic (e.g.