Associate Manager Medicines Quality Organization M

Associate Manager Medicines Quality Organization MQO #medicalwriting #medicalcommunications #medcomms #medicalwriter #healthcarecommunications #medicalwriters #medicalwritingtips #agencylife #medcommsjobs #wearewe #scientificservices #medcommsagency #medicalwriterlife #medcommsrecruitment #medcommscareers #medicalwritingservice #scientificdirector #seniormedicalwriter #medical #medcommslife #principalmedicalwriter #editorialteamlead #clinicaltrials #principalwriter #medicine #healthcare #pharmacovigilance #clinicalresearch #pharmacy #medicaleducation At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring lifechanging medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We re looking for people who are determined to make life better for people around the world. Purpose: This role is responsible for the design, implementation and execution of an integrated quality system to support LCCI s evolving business model. This role is responsible for clinical development quality assurance, quality risk assessment and mitigation, continuous quality improvement, and inspection readiness. The purpose of the role is to be a quality advocate for the Clinical Data Management CDM andor Statistics business units. For CDM, this requires an in depth understanding of data standards, data collection & design, data flow management, data quality, data validation, data review, central coding, data technology, dataset delivery, adjudication coordination, archiving and decommissioning. For Statistics, this requires an in depth understanding on establishing a reporting database and analyzing clinical trial data. The Quality Associate Manager works with management and the quality team to implement a strategy to strengthen quality of medical research by integrating quality into business processes. Primary Responsibilities: Functional and Technical Expertise Knowledge and experience in clinical development, development quality andor related areas. Indepth knowledge on end to end Clinical Data Management activities from study set up through database lock or indepth knowledge on statistics activities. Supports the Safety and Efficacy Quality System SEQS implementation and education of the business. Participates in SEQS procedure development and in Change Control as appropriate Functions as the initial point of consultation for the business on SEQS related question Responsible for providing input and feedback on quality standards and expectations Consultants on regulations and guidelines; provides interpretation, direct input into quality systems and defines the quality direction to comply with external and internal expectations. Informs and interprets changes in local, regional and global regulations Provides guidance and consultation to the business to enable execution of external and internal regulations on a local, regional and global level to , ensure compliance and inspection readiness Provides input into Global Quality Auditing and Compliance GQAAC audit plans and regional andor affiliate quality plans based on identified signalrisksgaps Defines, executes and documents quality selfassessmentsselfinspections throughout the clinical development process and discusses output with business partners Discusses output of quality selfassessments with business partners, provide recommendations on corrections and CAPA and monitor through to resolution Supports and educates the business in developing robust CAPA, deviation management, root cause investigation, audit response management and inspection response management Reports issues through Notification to Management NTM as appropriate Participates in the development and implementation of the quality strategy for the Portfolio and Medical Affairs Conducts process reviews based on quality data and trends. Shares results with the business Inspection Readiness and Inspection Management Leads preinspection preparation activities in collaboration with business partners Prepares and educates internal and external customersbusiness partners including investigator site staff on inspection management Actively supports site and sponsor inspections Responsible for inspection response management and tracking through resolution Coordinates audit responses including Trackwise system documentation Functions as an expert in corrective and preventative actions CAPA management Actively participates in lessons learnedshared learning sessions regarding clinical trial site support during inspections Quality Decision Making Uses risk based approach for effective communication to influence business decisions Provides feedback to the business on the benefits and risks associated with an issue andor business solution Influence Quality Direction Collaborates with other quality groups as appropriate and develops a quality network Collaborates with compliance as appropriate and develops a working partnership Shares key learning to drive simplification and replicate best practices Actively participates in team and supported business area meetings Acts as a point of contact and partner with compliance officerData privacy steward as appropriate Consults on deviation management and root cause analysis Utilizes quality experience to support change management and business transformation in the delivery of the portfolio Problem Solving Support business in resolution of issues Supports business in the escalation of issues including the escalation to leadership Anticipates broader impact of an issue Quality Technical Leadership Initiates, drives and coordinates quality improvement initiatives. Shares key learning's and drives quality into the business Project Management Supports the implementation of harmonization of best practices, process improvements and provides feedback on effectiveness of implementation, challenges and best practice Supports local, regional and global medical teams working on key projects Minimum Qualification Requirements: Bachelor s Degree in a science, technology or medicallyrelated field or equivalent relevant work experience A minimum of 2 years experience in clinical development, development quality andor related areas. Indepth knowledge on end to end clinical data management activities from study set up through database lock Indepth knowledge on statistics activities Global perspective and working across functional and geographical boundaries Knowledge of GxP regulations, guidelines and standards Demonstrated understanding of quality principles, including policies, procedures and processes Demonstrated ability to identify and prioritize quality issues. Knowledge of the relevant regulatory framework Ability to influence, negotiate and project manage Ability to work effectively at all level of the organization Effective organizationselfmanagement skills Excellent problem solving skills and initiative Proficient written and spoken English language skills Effective verbal communication Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries collectively Lilly are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources Lilly_Recruiting_Compliancelists.lilly.com for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. 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