Sr. Manager, Medical Device Safety - Bristol Myers Squibb
Princeton, NJ
About the Job
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .
Employer: Bristol-Myers Squibb Company
Position: Sr. Manager, Medical Device Safety (Ref: 4185)
Location: 3551 Lawrenceville Road, Princeton, NJ 08540
Duties: Serve as a senior subject matter expert (SME) on safety reporting requirements for medical devices & combination products by drawing on experience w/ medical device quality system regulations, including ISO 13485, 21CFR 820, 21CFR 803, EUMDR 2017/745, & combination product safety submission (21CFR Part 4b); understanding of global safety reporting regulations & guidelines, including the FDA, ICH, & EU Regulations & Requirements for Pharmacovigilance; Pharmacovigilance (PV) Safety Database; case processing, including knowledge of clinical trials/expedited ICSR submissions to health authorities; medical device & combination product submissions; complaint handling & customer service in the medical device or pharmaceutical industries; & clinical trials. Oversee post-marketing safety reporting of medical devices (21CFR Subpart H-Part 822) & combination product malfunction submission (21CFR Part 4b). Responsible for vendor oversight for medical device individual case safety report (ICSR) case processing. Participate in Quality Assurance related tasks for ICSRs, including review of cases, case correction requests, compilation of data, & presentation to the team. Track & ensure ICSR quality compliance & regulatory submission timelines. Collaborate w/ the manufacturing sites, device quality group, & product quality group for medical device safety reporting & risk management of the medical device & combination product-related complaints & ensure timely cross-functional evaluations of the complaints to support Pharmacovigilance compliance. Track & ensure compliance with internal & regulatory submission timelines. Responsible for the thorough review of the quality complaint database to identify device & combination product-related malfunctions, document, track, & provide relevant information for the ICSR process. Participate in updating the data entry manual & associated work instructions when new and/or updated conventions are introduced & train the team as appropriate. Identify & develop process improvements & database-related standard operating procedures, work instructions, job aids, & training materials within selected projects to meet short- & long-term objectives, including but not limited to compliance, productivity, & quality; work in a matrix environment to facilitate the allocation of required project resources; & deliver feedback on project deliverables. Support regulatory authority inspections & internal & external audits as a case management medical device safety SME. Partner with key stakeholders to develop a process & system for digital health safety reporting. Review large data sets, prepare reports for submission to the health authorities under strict timelines, & resolve respective queries regarding product safety. Provide expertise for the improvement of the Global Quality Database & Global Safety System for medical devices & combination product complaint records & ICSR case processing, respectively. Review, understand, & design safety reporting requirements for medical devices & combination products to meet global regulations. Identify key project issues & identify potential solutions to effectively streamline processes, as well as collaborate effectively with project teams, business partners, vendors, & colleagues to ensure solutions are implemented in a timely & concise manner. Exercise a high degree of adaptability in dealing with an ambiguous & complex work environment that includes demands from respective project teams & impacted internal & external stakeholders. May work remotely 5 days every 2 weeks within normal commuting distance of Princeton, NJ.
Requirements: Bachelor's degree in Drug Regulatory Affairs, Nursing, Chemistry, Life Science, Pharmacy or a related field plus 6 years of post-baccalaureate experience showing demonstrable ability in the skill set described above. The required skills do not need to be maintained over the full term of required experience.
The starting compensation for this job is a range from $121,368 - $164,204/year , plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
* If BMS Careers Site link is not copy and pasting correctly, please add manually using the following address: https://jobs.bms.com/careers/join (https://urldefense.com/v3/__https:/jobs.bms.com/careers/join__;!!DuJIhUBmA6S-!GFYwqJ9FcpS4VcwNRh6qASnLOR27THVN0aPC6dhLdD1i81FV-2ACGwSkTZLAAfFyWLexLn09mH-srZ1-KFpIGpO12i84N11smtM%24) .
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585815
Updated: 2024-09-30 06:06:22.285 UTC
Location:** Princeton-NJ
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.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .
Employer: Bristol-Myers Squibb Company
Position: Sr. Manager, Medical Device Safety (Ref: 4185)
Location: 3551 Lawrenceville Road, Princeton, NJ 08540
Duties: Serve as a senior subject matter expert (SME) on safety reporting requirements for medical devices & combination products by drawing on experience w/ medical device quality system regulations, including ISO 13485, 21CFR 820, 21CFR 803, EUMDR 2017/745, & combination product safety submission (21CFR Part 4b); understanding of global safety reporting regulations & guidelines, including the FDA, ICH, & EU Regulations & Requirements for Pharmacovigilance; Pharmacovigilance (PV) Safety Database; case processing, including knowledge of clinical trials/expedited ICSR submissions to health authorities; medical device & combination product submissions; complaint handling & customer service in the medical device or pharmaceutical industries; & clinical trials. Oversee post-marketing safety reporting of medical devices (21CFR Subpart H-Part 822) & combination product malfunction submission (21CFR Part 4b). Responsible for vendor oversight for medical device individual case safety report (ICSR) case processing. Participate in Quality Assurance related tasks for ICSRs, including review of cases, case correction requests, compilation of data, & presentation to the team. Track & ensure ICSR quality compliance & regulatory submission timelines. Collaborate w/ the manufacturing sites, device quality group, & product quality group for medical device safety reporting & risk management of the medical device & combination product-related complaints & ensure timely cross-functional evaluations of the complaints to support Pharmacovigilance compliance. Track & ensure compliance with internal & regulatory submission timelines. Responsible for the thorough review of the quality complaint database to identify device & combination product-related malfunctions, document, track, & provide relevant information for the ICSR process. Participate in updating the data entry manual & associated work instructions when new and/or updated conventions are introduced & train the team as appropriate. Identify & develop process improvements & database-related standard operating procedures, work instructions, job aids, & training materials within selected projects to meet short- & long-term objectives, including but not limited to compliance, productivity, & quality; work in a matrix environment to facilitate the allocation of required project resources; & deliver feedback on project deliverables. Support regulatory authority inspections & internal & external audits as a case management medical device safety SME. Partner with key stakeholders to develop a process & system for digital health safety reporting. Review large data sets, prepare reports for submission to the health authorities under strict timelines, & resolve respective queries regarding product safety. Provide expertise for the improvement of the Global Quality Database & Global Safety System for medical devices & combination product complaint records & ICSR case processing, respectively. Review, understand, & design safety reporting requirements for medical devices & combination products to meet global regulations. Identify key project issues & identify potential solutions to effectively streamline processes, as well as collaborate effectively with project teams, business partners, vendors, & colleagues to ensure solutions are implemented in a timely & concise manner. Exercise a high degree of adaptability in dealing with an ambiguous & complex work environment that includes demands from respective project teams & impacted internal & external stakeholders. May work remotely 5 days every 2 weeks within normal commuting distance of Princeton, NJ.
Requirements: Bachelor's degree in Drug Regulatory Affairs, Nursing, Chemistry, Life Science, Pharmacy or a related field plus 6 years of post-baccalaureate experience showing demonstrable ability in the skill set described above. The required skills do not need to be maintained over the full term of required experience.
The starting compensation for this job is a range from $121,368 - $164,204/year , plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
* If BMS Careers Site link is not copy and pasting correctly, please add manually using the following address: https://jobs.bms.com/careers/join (https://urldefense.com/v3/__https:/jobs.bms.com/careers/join__;!!DuJIhUBmA6S-!GFYwqJ9FcpS4VcwNRh6qASnLOR27THVN0aPC6dhLdD1i81FV-2ACGwSkTZLAAfFyWLexLn09mH-srZ1-KFpIGpO12i84N11smtM%24) .
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1585815
Updated: 2024-09-30 06:06:22.285 UTC
Location:** Princeton-NJ
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.
Source : Bristol Myers Squibb