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Medical Writing Documentation Expert 

Main purpose 

The Medical Writing Documentation Expert role provides support including content check and technical expertise to submission and clinical development projects. The Medical Writing Documentation Expert is accountable for all project deliverables and accurate timelines for tasks to ensure effective resource planning. The role ensures compliance with internal and external regulatory guidelines and processes.

The role requires deep expertise in regulatory requirements drug development process, as well as exemplary leadership, project management, diplomacy and problem-solving skills to drive complex projects to completion.

The incumbent is responsible for supporting clinical documents and clinical transparency projects by working with Medical Writers and clinical teams to help ensure high-quality, timely deliverables. By assisting in the training of new staff and contributing to redaction and translation activities, the incumbent promotes continuous improvement and adherence to technical standards for submission and clinical development projects.

Key work relations internal/external

• Medical writing roles

• Clinical Strategy Team members

• Clinical Study Team members

• Clinical Regulatory Submission Team members

• Clinical Trial Transparency

• External Vendors

Scope 

• Global

Key tasks & Responsibilities 

• Task coordination: Coordinate content and technical quality control, redaction, anonymization, and translation validations for submission relevant content

• Provides accurate timelines for all clinical documents in scope ensure effective resource planning

• Strategy: Support the execution of the Commercial Confidential Information (CCI) strategy preparation of justification documents in compliance with health authority requirements

• Task delivery: Support creation and timely delivery of clinical study report appendices, clinical study report publishing, anonymization reports, and translation validations

• Meetings: Supports the coordination of comment resolution meetings cross/functionally

• Best practice: Contribute to development of best practices documents, rulesets, user guides and internal training materials

• Training: Deliver onboarding and training on applicable submission guidelines, processes and systems

• Systems: Supports maintenance and updates of templates, tools and technical platforms, e.g. document management system, document review/comment system

• DSO behaviors: Act as a role model for our DSO behaviors - Focus on outcomes, include others, collaborate with accountability, co-create for customers; act, learn fast and evolve

Skills & Qualifications 

• Education: Bachelor degree or long-term working experience in the research or pharmaceutical industry

• Experience: Previous experience in pharmaceutical industry, preferably medical writing content and technical quality control

• Project management: Experience in project management, process development and/or coordination

• Technology: Excellent electronic content management

• Technology: Proficiency in testing and implementing new tools and platforms

Technology: Proficiency in testing and implementing new tools and platforms

• Communication skills: Strong verbal and written communication skills in English

• Collaboration: Proven ability to collaborate with internal and external stakeholders

• Strong ability to self-organize, pro-actively drive improvement, trouble-shooting, inclusive mindset, strong display of DSO behaviors.

Location:

Spain : Cataluña : Barcelona  

Division:

Pharmaceuticals 

Reference Code:

845990