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                    Medical Director Medical Safety Assessment

                    Bristol-Myers Squibb
                    Summit, NJ 07901
                    Full-time, Part-time
                    Similar jobs pay $38.63 - $66.40
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                    Job Description

                    Medical Director Medical Safety Assessment

                    Medical and Regulatory Affairs

                    • Summit, New Jersey, United States of America

                    At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

                    Functional Area Description

                    The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmacoepidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

                    Position Summary / Objective

                    • Leads all medical safety assessment and related activities for assigned assets

                    Position Responsibilities

                    • Leads Safety Management Teams (SMTs)
                    • In the area of safety surveillance/signal detection, evaluate and integrate data from multiple sources, including clinical, nonclinical, and real-world, to understand and manage safety signals
                    • Accountable for risk strategy, risk assessment, and risk minimization for BMS products in partnership with other BMS functions
                    • Serve as safety consultant for product development activities
                    • Leader or key contributor to responses to safety-related queries
                    • Medical safety lead for aggregate safety reports and other strategic documents
                    • Serve as a trusted partner to other BMS functions, representing the view on product safety
                    • Lead in a highly matrixed environment through scientific competency and organizational influence and impact
                    • Contributes to WWPS and BMS cross-functional improvement initiatives

                    Degree Requirements

                    Required: MD or equivalent degree. Has completed a Board certification and/or relevant higher medical training.

                    Experience Requirements

                    • Generally, has 3 or more years previous experience as medical safety assessment physician (MSAP)
                    • Experience requirement may vary based on relevant experiences and accomplishments, such as roles in:
                      • Pharmaceutical or biopharmaceutical industry
                      • Government (eg, US Food and Drug Administration)
                      • Clinical research
                      • Observational research
                      • Clinical practice experience
                      • Medical educator
                      • Medical administrator
                    • Medical quality assessment/improvement

                    Key Competency Requirements:

                    • Clinical knowledge base and sound medical judgement as demonstrated by clinical practice experience or comparable activity
                    • Strong written and oral scientific communication skills
                    • Strong scientific analytical reasoning skills
                    • Behavioral competencies necessary to work and lead within a complex highly matrixed environment
                    • Understanding of drug development process, with knowledge of design and execution of randomized clinical trials
                    • Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the lifecycle of a drug product
                    • Understanding of regulatory requirements for safety assessment and action throughout the lifecycle of a drug product.
                    • Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
                    • Microsoft Office Suite

                    Travel Requirements: Occasional travel within the US (eg, once every 2-3 months) and overseas (eg, once a year)

                    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 diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

                    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 with the resources to pursue their goals, both at work and in their personal lives.

                    By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases.

                    Explore Job Opportunities

                    A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol Myers Squibb is the right choice for your next career move.

                    Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more.

                    Bristol Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact adastaffingsupport@bms.com . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

                    The Physician Payment Sunshine Act (Sunshine Act) requires Bristol Myers Squibb to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database. For more information, click here.

                    Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. For our EEO Policy Statement, please click here . If you'd like more information on your EEO rights under the law, please click here: EEO is the LAW and Supplemental Information.

                    Posting ID: 567249823Posted: 2020-08-09