Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women''s Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world''s leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear. Global Electronic Data Capture We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.
If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes. The primary responsibility of this role, as Global Medical Standards Manager, is to be the key driver to the execution of the Global Medical Standards Strategy by acting as the managing function for all allocated standards development, maintenance, harmonization and improvement initiatives.
- Directing, project managing and leading (or where applicable, supporting) assigned functional nominees/global interdisciplinary and cross functional expert working groups to ensure the standards for protocol build ,data collection and provision, as well as analysis and tabulation across the whole clinical development process and portfolio are consistently defined, documented and improved in the most efficient manner
- Driving activities to ensure development and continuous improvement of applicable Global Medical and assigned Therapeutic Area Standards, including co-ordination of activities to ensure consistency throughout the whole standards hierarchy and applicable deliverables driven by interface functions
- Ensuring management and maintenance of the Global Standards Library/Dictionary and build for areas of standards scope expansion
- Evaluating and communicating training needs related to Standards Management and implementation, support development and deliver global training programmes within Global Development/Global Clinical Sciences
The incumbent will:
.Chair Global and/or all assigned Therapeutic Areas Standards Teams. Interdisciplinary Cross functional team members will report to the chair of the team for the portion of their resource assigned to these activities;
.Critically analyze all information for impact on the adequacy of the overall standards framework and develop and implement solutions for continuous improvement;
.Direct and Project Manage all activities to ensure timely and adequate development of new standards and processing of change requests, including ensuring adequate training for all operational users within Global Development;
.Ensure timely initiation of all activities to ensure development of standards for new assigned Clinical Projects . Participate as an active member on applicable Clinical Project Standards Teams to ensure consistency of approach throughout the standards hierarchy and optimization of resource assigned to standards development;
.Represent BHC directly on external cross industry standards related initiatives, eg, CDISC, CDASH, HL7, ensuring harnessing of best practice and implementation of necessary changes within the BSP standard management arena to reflect the requirements of the regulatory authorities for regulatory deliverables and best practice for data retrieval-and transformation;
.Produce business reports for senior management which provide oversight of the overall adequacy of the standards framework, including resource implications for new development/managing change requests through the consistent application of standards throughout the whole of Global development and Clinical Pharmacology;
.Ensure efficient interface and adequate communication lines regard all assigned standards related activities to all functional teams who use the deliverables of the Global Standards Management Function as the baseline for their operational activities;
.Ensure that the Global Standards Library/Dictionary is always reflective of the most current status and version of the standards, and that all entries are provided in the most timely and efficient manner to support operational implementation;
.Assure maintenance of standards during a complete lifecycle of a project and provide suitable reports for efficient usage Be the interface for all allocated functional experts within global interdisciplinary standard teams, providing guidance on rules and best practices as well as operational implications;
.Acts as mediator in controversial topics in assigned teams, influencing and convincing to assure adequate standards implementation.
The selected candidate is required to possess the following:
.A clear understanding of standards and a strong advocate of what they can do to assist Bayer in obtaining their goals of efficient and effective drug development;
.A mix of standards enforcement and flexibility is essential for standards to be effective in their implementation;
.A strong collaborator with proven ability to complete projects across international interdisciplinary groups is essential in managing this complex process. The technical complexity of these projects, compounded by the large number of trials and diversity of drugs under investigation, requires the incumbent to take a high level view of the standards under development;
.In order to implement these solutions under the constant pressure of rigid deadlines and cost constraints, incumbent must integrate analytic and theoretic expertise with a high degree of leadership and technical skills.
.Incumbent must be an effective decision- maker and must determine and achieve courses of action in high-stress, time-critical situations, which will meet every directive from upper management.
.The incumbent must be able to resolve growing conflicts between long-range goals and short-term requirements (e.g. outsourcing without standards to make a publication deadline vs. initial pooling of data);
.A BS or MS with 10 years of pharmaceutical industry experience in clinical trials with at least 5 years of experience in Data Acquisition & Management.
.In-depth knowledge of clinical development in order to have a thorough understanding of the end to end development processes, data flow processes in clinical development as well as clinical support systems know how and regulatory deliverables;
.Leadership, project management, resource, administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relation to global interdisciplinary cross-functional teams and associates both internal and external as well as to represent the company at PMA, DIA, and other professional organizations;
.Knowledge of German is desirable.
.Strong teambuilding skills are critical in achieving global adherence and understanding of the value of standards.
.The incumbent must champion the standardization effort globally promulgating its success through the publication of metrics and measurement of the global standards library;
.Ability to operate across all therapeutic areas, across all phases of drug development including life cycle management, and across the BSP worldwide organization. The incumbent will also be required to focus on multiple projects at one time, and must have the ability to organize activities in an uncertain, changing and often time sensitive environment;
.Provide clear vision, direction, and evidence of the benefits standardization brings to Bayer through repeated evaluation and demonstration of time and costs savings for each clinical project team.
.Medical Writing, Statistical analysis and Programming, Database design, in depth CDISC /CDASH knowledge expanding to protocol element design and integrated analysis and reporting requirements
*Salary and grade level will be commensurate with experience and/or education level.