<p>Working with Us</p> <p>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. Take your career farther than you thought possible.</p> <p>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.</p> <p>Ensure 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 ED-ICV QR processes.</p> <p>Key Responsibilities</p> <ul> <li>Performs scientific (content) and editorial (formatting) QR of ED-ICV and Clinical Pharmacology deliverables, ensuring: </li></ul> <p>o Good documentation principles (organization, clarity, completeness, scientific standards)</p> <p>o Intra- and inter-document consistency</p> <p>o Data accuracy against referenced source documents</p> <p>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 exposure-response reports, and components of documents such as INDs and NDAs for submission to health authorities</p> <ul> <li>Communicates QR observations to author(s)/stakeholders in a timely and effective manner </li><li>Serves as a subject matter expert on QR standards, tools, and processes, including representation on continuous improvement workstreams as appropriate </li><li>Active participation in select Departmental initiatives and process creation / revision / rollout </li><li>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 </li><li>Supports the oversight of outsourced (eg, CRO) QR activities, as appropriate, to help ensure standards are being maintained and high-quality deliverables are being provided to BMS </li><li>Provides instruction and guidance on templates, formatting and publishing to CROs, as applicable </li><li>Represents ED-ICV QR function in various Organizational meetings including those pertaining to registrational activities, when necessary </li><li>Provides input regarding metrics and other pertinent data summaries that are used by Leadership to objectify the QR Function's performance, future resource needs, etc </li></ul> <p>Qualifications & Experience</p> <ul> <li>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 </li><li>Experience in performing quality review of key clinical and regulatory/submission documents </li></ul> <p>o Expertise in interpreting data from a broad range of scientific disciplines to enable critical scientific reviews for protocols and submission-related documents</p> <p>o Understands pharmacokinetic (PK) and pharmacodynamic (PD) data and related terminology</p> <ul> <li>Specialized knowledge of editing and proofreading techniques for clinical and regulatory/submission documents </li><li>Experience in developing QR standards, tools, and continuous improvement processes and delivering QR-related training to key stakeholders </li><li>Requires minimal supervision and coaches/mentors new QR personnel and/or peers </li><li>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 </li><li>Advanced knowledge of global pharmaceutical drug development process and ICH/GCP guidelines </li><li>Able to manage timelines and quality of work while adhering to applicable SOPs/WPs </li><li>Able to multi-task and prioritize independently; detail-oriented </li><li>Excellent written and oral communication skills required </li><li>Manages internal and external challenges effectively; seeks conflict resolution through negotiation </li><li>Must possess strong interpersonal and communication skills, be a team player, and be willing and able to work in a fast-paced environment where evolving project priorities and timelines require flexibility </li></ul> <p>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.</p> <p>Uniquely Interesting Work, Life-changing Careers</p> <p>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.</p> <p>On-site Protocol</p> <p>BMS has an 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:</p> <p>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.</p> <p>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/eeo-accessibility to access our complete Equal Employment Opportunity statement.</p> <p>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.</p> <p>BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.</p> <p>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/</p> <p>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.</p>