Manager, Quality Review, ED-ICV
Manager, Quality Review, ED-ICV
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Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving teams. 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: quality of clinical and regulatory/submission documents through detailed data verification consistency and message clarity reviews. Provide subject matter expertise in the development of quality review (QR) standards tools and processes to optimize both quality standards and speed. Helps to set the overall strategy for and implementation of EDICV QR processes.
Key Responsibilities
Performs scientific (content) and editorial (formatting) QR of EDICV and Clinical Pharmacology deliverables ensuring:
o Good documentation principles (organization clarity completeness scientific standards)
o Intra and interdocument consistency
o Data accuracy against referenced source documents
Document types within scope include but are not limited to protocols protocol amendments informed consent documents clinical study reports investigator brochures safety update reports population PK and exposureresponse reports and components of documents such as INDs and NDAs for submission to health authorities
Communicates QR observations to author(s)/stakeholders in a timely and effective manner
Serves as a subject matter expert on QR standards tools and processes including representation on continuous improvement workstreams as appropriate
Active participation in select Departmental initiatives and process creation / revision / rollout
Supports onboarding training and/or mentoring of new QR personnel and/or peers including but not limited to liaising with CRO personnel who may be performing QR on behalf of BMS
Supports the oversight of outsourced (eg CRO) QR activities as appropriate to help ensure standards are being maintained and highquality deliverables are being provided to BMS
Provides instruction and guidance on templates formatting and publishing to CROs as applicable
Represents EDICV QR function in various Organizational meetings including those pertaining to registrational activities when necessary
Provides input regarding metrics and other pertinent data summaries that are used by Leadership to objectify the QR Functions performance future resource needs etc
Qualifications & Experience
Minimum of BS/BA degree preferably in the Life Sciences with 10 years of related experience OR MS/MA degree preferably in the Life Sciences with 8 years of related experience
Experience in performing quality review of key clinical and regulatory/submission documents
o Expertise in interpreting data from a broad range of scientific disciplines to enable critical scientific reviews for protocols and submissionrelated documents
o Understands pharmacokinetic (PK) and pharmacodynamic (PD) data and related terminology
Specialized knowledge of editing and proofreading techniques for clinical and regulatory/submission documents
Experience in developing QR standards tools and continuous improvement processes and delivering QRrelated training to key stakeholders
Requires minimal supervision and coaches/mentors new QR personnel and/or peers
Advanced working knowledge of computer applications and other tools used to facilitate document reviews (eg MS Office PDF annotation tools) as well as documentation management systems
Advanced knowledge of global pharmaceutical drug development process and ICH/GCP guidelines
Able to manage timelines and quality of work while adhering to applicable SOPs/WPs
Able to multitask and prioritize independently; detailoriented
Excellent written and oral communication skills required
Manages internal and external challenges effectively; seeks conflict resolution through negotiation
Must possess strong interpersonal and communication skills be a team player and be willing and able to work in a fastpaced environment where evolving project priorities and timelines require flexibility
If you come across a role that intrigues you but doesnt 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 Lifechanging 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 a supportive culture promoting global participation 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.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100% of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Manager
Employment Type
Full-Time
