YOUR TASKS AND RESPONSIBILITIES

• Direct the management oversight and development of Medical Writing Specialists, Redaction as well as System Development Experts, Process Analyst Lead and Support functions supporting all clinical development projects across all therapeutic areas, the SBU ONC and across all development phases (phase 1-3) globally. This includes support of projects sponsored by both R&D as well as the SBU Oncology, Medical Affairs, and strategic outsourced COSMOS studies;
• Responsible for ensuring that effective and simplified medical writing processes and standards are implemented in order to achieve high quality deliverables;
• Responsible for driving automation and standardization not only within Medical Writing but also in cross functional projects involving interacting functions;
• Responsible for developing and maintaining qualified in-house Medical Writing Specialists, Redaction Experts, Experts in System Development, Process Analyst Leads and Support as well as MW inspection and audit support globally;
• Responsible for developing and maintaining the budget of Medical Writing Operations to support Medical Writing globally;
• Work with the Medical Writing Sourcing Manager to implement global outsourcing strategy;
• Provide quality control (QC) of clinical documents across all clinical development, SBU ONC and related Medical Affairs projects globally;
• Ensure all quality related supporting documentation is available for inspection or audit, for both internally created and outsourced documents;
• Direct all Medical Writing related inspection, audit and CAPA activities;
• Direct the development of global clinical data transparency documents under the redaction process to ensure compliance of personal data privacy and commercial confidential requirements in accordance with new regulations and local law;
• Direct global process and technology improvement projects, develop the business case and manage the associated budget for these projects as required within Medical Writing;
• Evaluate and consider new innovations and technologies to ensure the global competitiveness of Medical Writing together with the Head of the newly formed group "System development and Automation" within Medical Writing Operations, in particular taking CDO Meidical Writing business needs into account;
• Head Medical Writing Operations reports to Head of Medical Writing (VP) and works in the R&D and submission team environment to provide global operational support to all clinical documents supported by Medical Writing across all therapeutic areas and the SBU ONC and across all development phases (phase 1-3);
• He/She ensures essential quality control and operational support is provided to all Medical Writing owned documents allowing the Medical Writers to focus on the strategy and content development of the respective clinical documents;
• He/She ensures all submitted clinical documents meet the all regulatory quality and technical requirements to avoid delays in global regulatory submission, review and approval;
• He/She ensures essential redaction of personal private data and commercial confidential information of all submitted clinical documents, including but not limted to EU Policy 70 submission, NIH positing, EU CTR 2019 related submission activities;
• He/She ensures coordinated and consistent quality control activities and operational support globally;
• The coordinated management of those activities can ensure consistently high standard, a centralized center of excellence, and the resource flexibility to create innovation in the organization;
• He/She directs the requirements, architecture and implementation of new processes and technologies to support the tactical and strategic objectives of Medical Writing;
• He/She strategically evaluates and considers how and when emerging pharmaceutical industry guidance, best practices, standards and new technologies relating to Medical Writing are applied, to ensure Medical Writing processes remain leading edge and that the associated global development business remains competitive;
• Due to the cross-functional and collaborative nature of Medical Writing processes, these considerations impact major development processes in associated functions including R&D, SBU Oncology, Clinical Operations, Global Medical Affairs and Pharmacovigilence, and Global Regulatory Affairs.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

• At least a Master degree and 8 years’ experience in the Pharmaceutical industry, or an advanced degree and at least 10 years of Pharmaceutical industry experience, of which 6 years should be related to medical writing, submission management or clinical operations;
• Advanced level of knowledge of all relevant industry guidance and standards (eg. FDA, EMA, ICH, HL7) as they relate to the creation, exchange and lifecycle management of healthcare information in any medical document format;
• Significant experience (5+ years) working in a cross-functional global environment is required;
• Possess proficiency in most of the following: business process modeling, document publishing, document redaction and clinical transparency, inspection and audit Documentum, Adobe Acrobat, project management, collaboration technology, validation, electronic signature technology, etc;
• Knowledge about new IT tools and platforms and interest in expanding technical skills;
• Strong communication skills, both written and verbal required to articulate concepts and ideas;
• The incumbent must be diplomatic, persuasive and be able to establish rapport with all levels of the organization;
• Effective leadership ability to develop and motivate internal or external personnel under his supervision;
• He/She must demonstrate an interest in and show evidence of broadening his knowledge base beyond the current assigned area of responsibility;
• The incumbent must effectively plan, manage and utilize the resources, which include personnel, budget and equipment;
• Deep understanding in the management of outsourced study activities and in the management of collaborations with CROs and service providers;
• Six Sigma certification (green belt level) would be a plus.