Medical Writing Operations Manager

This is a fully remote position, open to applicants in Greece.

📋 Description

• Offer direction to medical writing vendors and project teams regarding standard procedures for creating safety narratives, plain language study results summary (PLSRS) documents, and related deliverables within the Medical Writing scope.

• Tasked with directly utilizing and leveraging artificial intelligence (AI)-enabled tools, automation platforms, and document generation systems during the development of medical writing documents.

• Plan and oversee projects to ensure that vendors deliver completed work within established timelines, adhere to processes, and fulfill quality standards.

• Identify, communicate, and address issues impacting project timelines, processes, and/or quality.

• Manage routine interactions with vendors, which includes preparing work requests.

• Participate in regular operational governance meetings with vendors.

• Assist management with forecasting by generating and/or reviewing reports from internal systems.

• Supervise vendors by gathering and assessing key performance indicator metric data.

• Support workstreams in evaluating solutions aimed at enhancing the operational efficiency of business processes.

⛳️ Requirements

• A minimum of a bachelor’s degree or equivalent in a medical-related field or life sciences.

• 5 years of experience with a BS/BA, or 3 years with an MS/MA in medical writing or vendor management within the pharmaceutical or biotech industry.

• Experience in overseeing multiple medical writing deliverables at various stages across different project teams and vendors.

• Ability to work independently with minimal supervision, manage multiple tasks, and function effectively under pressure; adaptability to change as required; capability to analyze and resolve moderately complex issues; and possess strong project management and issue resolution skills.

• Proficient in the application of automation and AI for developing medical writing documents, including the ability to utilize automation/AI tools.

• Familiarity with the drug development process, including knowledge of ICH and other regulatory guidelines, with the ability to interpret and apply these guidelines.

• Proven track record of delivering within established internal and regulatory timelines; monitoring and communicating progress against milestones; and appropriately escalating moderately complex issues.

• Understanding of vendor processes and best practices in outsourcing.

• Excellent written and verbal communication abilities.

• Strong attention to detail and organizational capabilities.

• Experience with software commonly utilized for presenting and analyzing data, including Word, PowerPoint, and Excel.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development