Provide guidance to medical writing vendors and project teams on standard processes for preparing safety narratives, plain language study results summary (PLSRS) documents, and associated deliverables within scope of Medical Writing.
Responsible to directly use and leverage artificial intelligence (AI)-enabled tools, automation platforms, and document generation systems in the process of developing medical writing documents.
Plan and manage projects to ensure that vendors complete deliverables within agreed-upon timelines, follow processes, and meet quality expectations.
Identify, communicate, and resolve issues affecting project timelines, processes, and/or quality.
Manage routine vendor interactions, including preparation of work requests.
Attend regular operational governance meetings with vendors.
Assist management with forecasting by generating and/or reviewing reports from internal systems.
Oversee vendors by collecting and reviewing key performance indicator metric data.
Support workstreams to evaluate solutions to improve operational efficiency of business processes.

At minimum bachelor’s degree or equivalent in medical-related field or life science.
5 years with BS/BA, 3 years with MS/MA of medical writing or vendor management experience in the pharmaceutical or biotech industry.
Experience with overseeing multiple medical writing deliverables at various stages across multiple project teams and vendors.
Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; ability to analyze and solve moderately complex problems; and possess excellent project management and issue resolution skills.
Proficient in application of automation and AI in the development of medical writing documents, including the ability to use automation/AI tools.
Understanding of the drug development process, including knowledge of ICH and other regulatory guidelines, and ability to interpret and apply guidelines.
Demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; and escalate moderately complex issues appropriately.
Knowledge of vendor processes and best practices in outsourcing.
Excellent written and verbal communication skills.
High level of attention to detail and organizational skills.
Experience with software commonly used to present and analyze data, such as Word, PowerPoint, and Excel.

Medical Writing Operations Manager

Key skills