Medical Writer II

Responsibilities

• Defines scope of quality control activities with the document author and the required source documents and data required.
• Conducts independent quality control review of documents per applicable checklist by checking against source documents to ensure results are accurate.
• Ensures quality control documentation is complete and accurate and uploaded to the master file per the established business processes.
• Maintain strong knowledge of clinical regulatory documents requiring quality control review and business processes.
• Interacts daily with medical writers and/or medical writing managers and interfaces/communicates with applicable cross-functional areas.
• Communicates and provides deliverables to medical writers, medical writing managers, and others as applicable.

• Bachelor's degree required.
• Bachelor's degree in science, English, or Communication preferred.
• 2-3 years in relevant industry experience in quality control/review of clinical regulatory documents or related experience in an area such as quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D.
  
  Note:
  
  Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
• Excellent knowledge of organization and content of clinical documents and eCTD structure.
• Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
• Excellent oral/written communication, interpersonal/organizational, analytical/critical thinking, and conflict management skills.
• Superior attention to detail and ability to prioritize multiple tasks/projects.
• Experience in 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.
• Proofreads, circulates, edits, assembles, inspects and duplicates product submissions.
• Experience Level = 3-5 Years.

Associate

Contract

Marketing, Public Relations, and Writing/Editing

Pharmaceutical Manufacturing