Katalyst CRO
Medical Writer II
at
Katalyst CRO
Medical Writer II – responsible for quality control and review of clinical regulatory documents and ensuring accurate, compliant submissions.
Responsibilities
Define the scope of quality control activities with document authors and determine required source documents and data.
Conduct independent quality control reviews of documents against applicable checklists, verifying accuracy against source data.
Ensure quality control documentation is complete, accurate, and uploaded to the master file following established business processes.
Maintain strong knowledge of clinical regulatory documents that require quality control review and related business processes.
Interact daily with medical writers, medical writing managers, and cross‑functional teams to coordinate quality control activities.
Communicate and provide deliverables to medical writers, managers, and other stakeholders as required.
Requirements
Bachelor’s degree required.
Bachelor’s degree in science, English, or Communication preferred.
2–3 years of relevant industry experience in quality control/review of clinical regulatory documents, or related experience in quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D.
Excellent knowledge of the organization and content of clinical documents and eCTD structure.
Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
Excellent oral and written communication, interpersonal/organizational, analytical/critical thinking, and conflict management skills.
Superior attention to detail and ability to prioritize multiple tasks or projects.
Experience working with collaborative cross‑functional teams.
Operates with limited oversight.
Prepares technical documents to support both domestic and international regulatory submissions.
Incorporates text, graphs, charts, tables, and statistical analysis into documents.
Proofreads, circulates, edits, assembles, inspects, and duplicates product submissions.
Experience level of 3–5 years.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Marketing, Public Relations, and Writing/Editing
#J-18808-Ljbffr
at
Katalyst CRO
Medical Writer II – responsible for quality control and review of clinical regulatory documents and ensuring accurate, compliant submissions.
Responsibilities
Define the scope of quality control activities with document authors and determine required source documents and data.
Conduct independent quality control reviews of documents against applicable checklists, verifying accuracy against source data.
Ensure quality control documentation is complete, accurate, and uploaded to the master file following established business processes.
Maintain strong knowledge of clinical regulatory documents that require quality control review and related business processes.
Interact daily with medical writers, medical writing managers, and cross‑functional teams to coordinate quality control activities.
Communicate and provide deliverables to medical writers, managers, and other stakeholders as required.
Requirements
Bachelor’s degree required.
Bachelor’s degree in science, English, or Communication preferred.
2–3 years of relevant industry experience in quality control/review of clinical regulatory documents, or related experience in quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D.
Excellent knowledge of the organization and content of clinical documents and eCTD structure.
Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
Excellent oral and written communication, interpersonal/organizational, analytical/critical thinking, and conflict management skills.
Superior attention to detail and ability to prioritize multiple tasks or projects.
Experience working with collaborative cross‑functional teams.
Operates with limited oversight.
Prepares technical documents to support both domestic and international regulatory submissions.
Incorporates text, graphs, charts, tables, and statistical analysis into documents.
Proofreads, circulates, edits, assembles, inspects, and duplicates product submissions.
Experience level of 3–5 years.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Marketing, Public Relations, and Writing/Editing
#J-18808-Ljbffr