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Bristol Myers Squibb
,
Uxbridge, Greater London
Global Submission Management - EU Clinical Trial Regulation Lead
Overview
Job Description
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Global Submission Management (GSM) is an organization that provides proactive, therapeutic area-specific document and submission strategies to efficiently manage and dispatch regulatory submissions. The GSM Clinical Trials team (GSM-CT) plan, coordinate, prepare and track documentation required for the clinical trial application to Competent Authorities (CAs) and/or Ethics Committees (ECs) to start and execute a BMS sponsored Interventional studies. In scope - all countries involved in CTs except the US Purpose/Objective of the job This role will drive the strategic and operational aspects of the Clinical Trial Application process and its evolution, with a primary focus on the EU Clinical Trial Regulation. This role will assess and lead the "enterprise wide" process changes for the implementation of the new EU CT Regulation. This role engages across the business while building efficiencies in the process and ensuring connectivity to external forums in this space. Key Responsibilities and Major Duties * Lead BMS EU CTR cross-functional team for the successful implementation of the Regulation: * Acts as BMS EU CTR content expert * Leads Workstream (WS) lead meetings following up on WS deliverables to ensure overall Project plan is on track * Assesses and supports the implementation of required internal changes across impacted departments * Regularly reports progress, informs of internal/external updates, escalates challenges to EU CTR Sponsors * Ensures connectivity with internal initiatives and continuous Improvement Projects * Develops and executes communication plan to create internal awareness * Ensures key implementation challenges are addressed by proposing and supporting Continuous improvement Projects * Represent BMS/Industry in the development of the CTIS (EU Portal) as appropriate Competencies - knowledge, skills, abilities, other * Degree - Knowledge equivalent to that attained with a Bachelor's degree in Life Sciences, Allied Health, Pharmacy, Nursing, a Master's degree is preferable * Knowledge - Candidate must have a minimum of a BA or BS Degree with approximately 8+ yrs. of experience in clinical drug development. * Knowledge of the pharmaceutical industry and of the pre-clinical, clinical, regulatory and commercial components, the drug development process and the impact of the European Clinical Trial Directive on BMS policies and procedures. * Broad knowledge of the Clinical Trial Application process and thorough understanding of ICH-GCP guidelines and local regulatory guidelines or regulations worldwide as they apply to the Clinical Trial Application and Transparency processes. * Experience in Clinical Operations, Submission Process, Regulatory or equivalent in the pharmaceutical/biotech industry * Desirable demonstrated track record of working with external working teams and governance meetings (e.g. EFPIA, EMA, TransCelerate). * Effective oral and written communication skills to influence, inform and guide a large scale global operational team. * Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams. * Role is a driver for continuous improvement and compliance in this space * Ability to analyze trends and identify potential risks, communicate and influence others to take action to mitigate risks. * Represents the department on broader process improvement or other initiatives. Role interacts with senior stakeholders within different groups. 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.