Medical Writing Operations Manager

Use Your Power for Purpose

By connecting evidence-based medical decision support with colleagues and stakeholders, you will help achieve better health and treatment outcomes. Your work will ensure our evidence is scientifically robust, provide unbiased and medically necessary expertise, and investigate ways to close data gaps. Your role is crucial in enabling the safe and appropriate use of medicines for patients, ultimately contributing to our mission of empowering healthcare decisions.

What You Will Achieve

In this role, you will:

• 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. Guidance is based on understanding and knowledge of the underlying operational principles of applicable processes.

• 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. Includes ability to communicate with stakeholders about automation/AI tools; support tool assessments to improve technical solutions, user acceptance testing, and implementation efforts; harness prompt generation and application; and other relevant activities.

• 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. Suggest moderately complex changes to improve operational efficiency.

Here Is What You Need:

• At minimum bachelor’s degree or equivalent in medical-related field or life science. (BS/BA +5 years, MS/MA +3 years 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; to identify and escalate technical issues; to support change management by guiding stakeholders through the adoption of new technologies; and demonstrate responsible AI practices, including risk management and ethical use.

• 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.

Non-standard work hours will be required as this is a global role, in a team whose stakeholders and resources are largely based in US.

Work Location Assignment: Remote - Field Based

Please apply by sending your CV and a motivational letter in English


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