Manager, Quality Review, ED-ICV

About the position

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. 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.

Responsibilities

• Performs scientific (content) and editorial (formatting) QR of ED-ICV and Clinical Pharmacology deliverables, ensuring good documentation principles, intra- and inter-document consistency, and data accuracy against referenced source documents.
• 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 liaising with CRO personnel who may be performing QR on behalf of BMS.
• Supports the oversight of outsourced (eg, CRO) QR activities to help ensure standards are being maintained and high-quality deliverables are being provided to BMS.
• Provides instruction and guidance on templates, formatting and publishing to CROs, as applicable.
• Represents ED-ICV 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 Function's performance, future resource needs, etc.

Requirements

• 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.
• Expertise in interpreting data from a broad range of scientific disciplines to enable critical scientific reviews for protocols and submission-related documents.
• 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 QR-related 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 multi-task and prioritize independently; detail-oriented.
• 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 fast-paced environment where evolving project priorities and timelines require flexibility.

Benefits

• Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives.