Senior Project Manager, Clinical Risk Evaluation

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.     JOB DESCRIPTION:Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with a high employer contributionTuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticksThe Opportunity Our locations in Plano, TX, Austin, TX, Maple Grove, MN or Santa Clara, CA currently have an opportunity for a Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager. The Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager is to provide technical and strategic expertise throughout the product development and life cycle process; daily activities are related to management and alignment of risk information for Neuromodulation products. The CRE Program Manager writes and manages risk evaluation files, performs risk analysis, manages the development of clinical evaluation plans and reports and interacts with various cross-functional teams in order to assist in strategy, plans, and project deliverables. Must be able to effectively manage multiple projects and timelines.What You’ll Work OnIndependently creates and maintains Risk Evaluation Files (REF)s Abbott products. Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references. Oversees CROs, actively manages timelines and project delays/risks, develops scenario’s and recommendations for management.Leads risk alignment committee meetings (departmental multidisciplinary team), facilitates therapeutic team participation as appropriate, facilitates informed decision-making and dissemination of scientifically balanced and quality risk information regarding products. Ensures effective communication to clinical safety, clinical science, clinical internal and external operations, product performance, medical affairs, Clinical R&D, Quality Engineering, regulatory affairs, product labeling, senior management, and external CROs or medical writers. Conducts team meetings, sends routing communications and/or presents regular updates to senior staff.Develops and maintains Risk Evaluation Files (REF) DOP and associated documentation, provides input to cross-departmental SOPs and DOPs describing risk information processes. Develop templates taking into account all applicable regulations.Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports, Summaries of Safety and Clinical Performance (SSCPs) and associated documents; set deliverable and project timelines and ensure timelines are met.Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents.Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions.Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams.Compliance with applicable corporate and divisional policies and procedures.Participate in and support internal and external audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics.Provide and implement innovative ideas and solutions to Clinical Risk Evaluation group (e.g. database, LEAN projects), develop and roll out functional trainings as required.Reviews IFUs, patient guides, Risk Management, Clinical Evaluation Protocol, Clinical Evaluation Report (CEP/CER), IBs, study protocols, study ICFs, physician training materials, ensuring alignment of risk information. Involves in responses to complex costumer queries (e.g. regulatory authority, ethical committee, …) related to risk information. Reviews and gives input to Post-Marketing Su