Business Development & Continuity Expert
 Advanced Clinical | |
 United States, Connecticut, Ridgefield | |
 Jan 03, 2025 | |
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OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Business Development & Continuity Expert in Ridgefield, CT. The Business Development & Continuity Expert role represents the Pharmaceutical Development department in audits and inspections by global regulatory authorities, collaborating cross-functionally with various global partners. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES * Responsible for monitoring all archiving activities within the IMP Delivery and main contact person for all archive-related topics, processes, and OMS systems accessed by IMP Delivery. * Independently represents the global IMP Delivery in both internal and external regulatory audits and inspections. Ensures that current supply chain information, processes, and SOPs are available and that inquiries and questions from auditors and inspectors are answered promptly. * Responsible for independent analysis and evaluation of temperature deviations in drug product logistics and storage, as well as initial assessment and documentation of deviations and complaints in the corresponding IT systems. * Responsible CPI project leader for innovation-related projects and provision of tools, project charters, as well as updates and training within the agreed timeframe with the steering committee and process owner. * Actively questions existing business models and processes and takes on the roles of coach and trainer during the introduction and implementation phase. * Continuously develops and generates new ideas and concepts within the supply chain process. Presents these ideas to the leadership team for further evaluation. * Conducts quarterly training for IMP Delivery business partners and GxP and HSE training for IMP Delivery as needed. * Responsible for maintaining the audit and inspection schedule and presenting the risk status to the management team to ensure that the IMP Delivery is in the best possible compliance readiness situation. Leading the Risk Management Committee and ensuring that actions are addressed in a timely manner and regular trainings and newsletters are published. EXPERIENCE Minimum of five years in a similar environment for business development or consulting, demonstrating advanced knowledge in project management in an innovative and regulated environment. EDUCATION Minimum of Master's degree in natural sciences or engineering. To be a best-fit your strengths must include: * Effectively lead teams, define tasks, clearly set expectations, identify measurable results, effectively handle conflicting situations, and express complex scientific principles in both German and English through presentations to internal and external partners. * Leadership qualities are necessary. * In-depth knowledge and interpretation of GMP, GCP, and HSE guidelines, consulting, and Six Sigma Project Management training. About Advanced Clinical Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com. Regarding your application Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately. | |