Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious diseases; empowered to apply our individual talents and ideas so that we can learn and grow together; and driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Description of the area:
R&D Quality – Clinical Trials and Safety, R&D Quality-CT&S (former GQRC-CT&S) is responsible for auditing all processes related to clinical research including specific medical affairs processes, and pharmacovigilance activities, to assess compliance with relevant regulations and applicable policies and procedures. This includes investigator site, internal systems (e.g. REMS, clinical monitoring), and external clinical trial related vendor audits. It is also responsible for management of regulatory agency inspections and for providing advice on regulatory requirements.
Purpose/Objective of the job:
· To conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits as above described.
· To act as project-specific liaison between R&D Quality - CT&S and key stakeholders, including Global Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel, monitoring the status of the project(s) to plan audits and assuring R&D Quality - CT&S leadership as informed.
Key Responsibilities and Major Duties:
· Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internal systems and clinical study reports to assess regulatory compliance;
o Apply audit principles, procedures, and methods; Collect information through effective interviewing, listening, observing and reviewing documents, records and data;
o Prioritize and focus on matters of significance; Confirm the sufficiency and appropriateness of audit evidence to support audit findings and conclusions;
o Assess those factors that may affect the reliability of the audit findings and conclusions;
o Prepare clearly-written, concise, accurate and evidence-based audit report;
· Review and assess received corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence.
· Maintain an in-depth knowledge of governmental regulations impacting clinical research and PV and development of medicines.
· Provide advice and counsel concerning GCP regulatory requirements.
· Act as project-specific liaison (Project Coordinator) and provide input into audit plans and strategy.
· Regularly evaluate key PV and clinical research processes to determine compliance with regulatory requirements and established standard operating procedures.
· May provide mentoring for new staff, as needed.
· Regular contact and collaboration with R&D Quality-CT&S management and colleagues/co-auditors located globally.
· Contact with appropriate technical, supervisory and management personnel internally and externally (investigator sites, vendors, etc.) in the conduct and reporting of audits.
· Regular collaboration/contact with GCO and GRSB personnel related to projects for which the incumbent is Project Coordinator.
· Possible interactions with external auditors and Regulatory Agency inspectors during the conduct of health authority inspections either at clinical sites or at BMS facilities.
· Miscellaneous contacts as assigned by R&D quality -CT&S management.
List of minimum requirements
o University Graduate, Life Sciences degree preferred
o Solid previous experience in clinical trial related roles (such as Protocol Manager, Senior Site Manager, Operational Lead etc).
o Demonstrated specific technical knowledge of the GCP areas subject to audit, as evidenced by at Ieast 1 - 4 years in the pharmaceutical industry, preferably in the R&D/clinical trial or equivalent area.
o Desired minimum 2 years of GCP auditing preferred.
o Good understanding of the drug development process;
o Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication;
o Excellent oral and written communication;
o Fluent in English (and other languages, as applicable to assigned audit region);
o Sense of diplomacy and discretion;
o Maintains the confidentiality and security of information, data and records;
o Demonstrates commitment to delivering high-quality work product;
o Knowledge of governmental regulations impacting clinical research and development
o Understand the appropriateness and consequences of using sampling techniques for auditing;
o Strong critical thinking to analyze complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions;
o Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective;
o Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;
o Develops strong working relationships with key stakeholders;
o Ability to manage competing priorities.
Working Conditions :
o Travel Required (nature and frequency) Approximately 25% travel to perform audits and attend professional meetings and seminars.
o Overnight Absences Required (per typical month): Approximately 5 days per month.
o Software that must be used independently and without assistance (e.g., Microsoft Suite).
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.