Manager, Medical Writing

Responsibilities

• Manage and supervise junior medical writers and/or external contractors
• Oversee and/or participate in the development/writing of:
• Clinical Development Plans (CDPs)
• Clinical study protocols and Clinical Study Reports (CSRs)
• Coordinating and integrating writing of other document sections provided by the project statistician, medical monitor, and other team members
• Clinical sections of INDs, NDAs/BLAs and MAAs and other submission documents (e.g., ISS/ISE, Clinical Summaries)
• Initial and or updates for Investigator Brochures (IBs) and IMPDs
• Annual reports and DSURs
• Briefing documents for regulatory submissions
• Journal articles, abstracts, and posters in cooperation with statistical leads
• Ensure documents meet company, client, and regulatory standards, including ICH/GCP guidelines
• Oversee multiple projects simultaneously, ensuring timelines and deliverables are met
• Conduct document review meetings to discuss comments/ edits by PROMETRIKA Team and/or Sponsor
• Attend client meetings as required
• Assist with tracking and reporting significant changes in scope of work and recommending change of scope orders to management, when appropriate
• Perform other duties as assigned

Qualifications

• Education: Bachelor’s Degree in Science is required. MS or a Ph.D. is preferred
• Experience: A minimum of 10 years experience in biotechnology/pharmaceutical industry. A minimum of 7 years regulatory writing in biotechnology/pharmaceutical industry. Experience managing medical writers or contractors preferred. Previous experience in developing clinical and regulatory documents, such as protocols, CSRs, IBs, INDs, ISS/ISE, and DSURs. Previous involvement in writing at least one NDA/BLA/ MAA is required. Previous experience working in a clinical research organization (CRO) is strongly preferred
• Skills: Knowledge of ICH /GCP, FDA, EMA and other regulatory guidance for clinical and regulatory submissions. Strong command of scientific and medical terminology with the ability to translate complex information into clear, accurate, and regulatory-compliant content. Excellent written and verbal communication skills, with attention to detail and quality. Ability to manage multiple projects and competing priorities in a fast-paced environment. Knowledge of electronic document platforms is desired. Additional knowledge/experience in other aspects of drug development (e.g., clinical trial monitoring, data management, statistics) is preferred