Manager Medical Writing

As a Manager of Medical Writing, your role will involve managing the performance and workload of Medical Writers. You will be responsible for short-term and long-term resource planning to assign projects appropriately. Your key responsibilities will include supervising the preparation of deliverables, organizing processes to meet timelines, and evaluating the timeliness and quality of work. Additionally, you will be assisting writers with data presentation and interpretation, performing peer reviews for adherence to standards, participating in SOP and WPD preparation and review, and evaluating compliance. Key Responsibilities: - Supervise Medical Writers - Train writers and assess their output - Support short-term and long-term resource planning to assign projects to appropriate and available staff - Assist staff with forecasting project-related costs and timelines for completion - Support hiring and evaluation of new employees - Supervise Medical Writing deliverables - Evaluate timeliness and quality of deliverables and provide updates to senior management - Perform peer reviews to ensure overall adherence to departmental standards - Stay updated on the guidelines and requirements of the ICH, FDA, and other relevant agencies - Give marketing presentations to potential clients on the capabilities of Medical Writing - Use clinical knowledge to assist in the written interpretation of clinical data and guide others in their presentation of clinical data Qualifications Required: - Bachelor's degree in a science-related field required; Advanced degree (PharmD, PhD, Masters) preferred - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience - 8 years of relevant experience in regulatory medical writing - 2+ years of leadership (team management) responsibility; longer tenure would be preferable Please note that the job types available for this position include Full-time, Permanent, and Freelance. The work location is in person.,