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 e nsuring 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.
Bayer’s corporate culture is an important factor in the company’s success. Central to this culture are our values: Leadership, Integrity, Flexibility and Efficiency, summarized by the term LIFE. They provide us with guidance for our daily work as we seek solutions to the major challenges of our time, in line with our mission statement Bayer: Science For A Better Life". GCP Study Audit Mgmt North America 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.
• Conduct, on a global level, GCP audits of clinical studies, suppliers, and documents (such as protocols and its associated documents) to assess whether all aspects of the clinical investigation and internal processes are in compliance with applicable regulatory requirements and established company procedures. This will include interviews with, and feedback to, Principal Investigators, who may be key opinion leaders in a particular therapeutic area. Provide timely feedback by means of the audit report, assess and approve corrective/preventive actions proposed by responsible parties, and contribute quality compliance data for metrical analysis.
• Manage clinical study site and supplier audit activities for key compounds. This will include managing complex, important, or multiple projects on a regional or trans-regional basis: interact with product development teams (in particular, the GCL) to identify and characterize new clinical studies as potential candidates for audit, proactively advise the GCL of audits planned and conducted, and of any significant quality issues arising from the audit program; for individual studies interact with study managers to develop and refine audit plans; interact with the Head, GSAM to ensure agreement, tracking, and fulfillment of the audit plan; develop audit tools (such as checklists); review draft audit reports; and prepare and distribute the Study Audit Summary report summarizing all significant study audit findings. Provide audit certificate for Clinical Study Reports.
• Lead or participate in Global System Audit teams including the development of the audit plan, training the audit team, developing tools for conducting such audits, managing the team during the conduct of the audit, and reporting the results to Global Functional Heads. The leader of a Global System Audit Team ensures timely completion of all audit related activities.
• Participate in compilation of GCP Quality Reports to identify problem areas in clinical drug development; participate in developing process improvement recommendations for both Global Development and Clinical Sciences. Proactively contacts the local clinical department to arrange a presentation of the data, makes the presentation and advises on areas of improvement.
• Lead or participate in regulatory authority pre-, during-, and post-inspection activities as needed and requested by Global Development Quality (GDQ) management (e.g., as chair of an inspection committee, serving as an Inspection Committee member, advising on preparations for inspections, conducting pre-inspection audits, and/or serving other roles as defined by the Inspection Committee) to promote the successful outcome of the inspection.
• Provide interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current GCP standards. This often involves sponsorship of issues for global QM consensus or acting as the primary GCP consultant for quality system Expert Working Groups.
• Support the development and refinement of the Global Quality System by leading or participating in SOP/OM authorship or review teams.
• Conduct training on the audit process and other processes owned by GDQ for internal and external customers (e.g., new hires and consultants to Clinical Development, suppliers, and clinical investigators at Investigator Meetings).
• Act as a coach/mentor in the development of less-experienced auditors.
• Education: Requires a BS in a biomedical science, or equivalent education with at least 8 years of pharmaceutical industry experience, or a MS in a biomedical science, or equivalent education, with at least 7 years of pharmaceutical industry experience
• Experience: The position requires a minimum of 5 years of clinical research related activities (e.g., monitor, study coordinator) and a 2-3 year proven record in GCP auditing activities. An in-depth knowledge and experience in the application of good clinical practice (GCP) requirements is required (e.g., ICH, FDA, etc.), as is familiarity with the essential documents related to clinical studies. The incumbent should be familiar with medical terminology and routine medical tests and procedures. Familiarity with computerized clinical data collection systems and biomedical statistics is needed.
• Competencies: The incumbent must possess strong interpersonal and oral and written communication skills in order to effectively and independently conduct audits and communicate results. Oral and written proficiency in the English language is required. Incumbent must also be confident and adept in the use of computerized databases and other applications. Professionalism is mandatory as the incumbent must interact directly with all levels of Bayer Pharma staff up to and including Sr. Vice President level and with clinical investigators, providers of services to Bayer Pharma and others. The ability to develop interdepartmental relationships is critical. Incumbent must be able to assimilate large amounts of data efficiently, exercise sound judgment and maintain composure in order to effectively handle sensitive issues, such as instances of serious clinical noncompliance. Proven project management skills, including effective planning and organizational skills, attention to detail and excellent follow through. The incumbent must be aware of the key differences in how business is practiced various countries to work effectively with various cultures. It is essential to be aware of the key cultural customs and practices that will create an effective working relationship and effectively represent Bayer Pharma as a multinational corporation.
• This position involves approximately 40 – 50% regional and global travel.
****Salary and grade level will be commensurate with experience and/or education level.****