Global Medical Writing Coordinator in Biberach an der Riß bei BI Pharma GmbH&Co KG

The Position

Tasks & responsibilities

• GMW Planning: With your expertise, you will be responsible for resource planning using a global planning tool and coordinating with different stakeholders within the department. You will create various analyses of the data contained in the tool and act as the main contact person and key user for the planning tool.
• CRO Outsourcing Service: As a Global Medical Writing Coordinator, you will oversee vendor management and task delegation to external partners, involving both clinical and regulatory documents or lay documents. Responsibilities include onboarding and supporting external partners, monitoring timelines, evaluating performance indicators, and organising necessary training or meetings. You will work closely with other team members and functions to streamline and improve processes.
• Contract Management: You will handle contract management, from negotiating with external partners to vendor qualification, contract extensions and adjustments, and monitoring contract terms. This also encompasses invoice verification and budget monitoring.
• Quality Management: In your new role, you will carry out tasks related to quality control (QC) and be responsible for conducting and/or managing QC of clinical, regulatory, and lay documents, as well as other assigned documents within Global Medical Writing. You will also manage the outsourcing of QC activities, ensuring the quality of deliverables through training and vendor oversight. You will independently perform QC checks on various document types and collaborate with the team to create and update How To Guides and checklists.
• Additional Responsibilities: The Global Medical Writing Coordinator role also involves coordinating data transparency processes. Therefore, you will coordinate the different stakeholders involved for publication of clinical documents with redacted information.
• Project Management: In all areas, you will conduct analyses based on key figures and indicators. You will be responsible for project coordination related to existing processes, including their optimisation or the introduction of new processes, such as new document types in the Global Medical Writing portfolio or new tools that support your work, etc.

Requirements

• Completed Bachelor's degree in a relevant field (e.g., Business Administration, Data Science in Medicine) ideally with several years of professional experience, or alternatively, completed vocational training (e.g., Management Assistant for Office Management, Industrial Management Assistant) with extensive professional experience
• Solid understanding of the phases and functions in clinical research
• Experience in collaborating with external partners
• Experience in resource planning
• Outstanding intercultural communication skills
• Ability to work collaboratively with other team members and functions, utilising everyone’s individual skills and abilities to achieve a common goal
• Fluent English proficiency in both speaking and writing

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