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Protocol Model Document Content Steward

External
Bristol-Myers Squibb logoBristol-myers Squibb · Warsaw, Poland
Full-timeRemote1d ago
Clinical TrialsDocumentationGCPLeadershipSAFe
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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. 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 . What if your work shaped the blueprint for life-changing clinical trials? Every groundbreaking medicine that reaches a patient starts with a protocol. And every protocol starts with a document that has to be precise, compliant, and built to last . That's where you come in. At BMS, we're looking for a Protocol Model Document Content Steward - someone who takes genuine pride in the craft of clinical documentation, who sees structure and governance not as red tape, but as the foundation that keeps patients safe and science moving forward . This isn't a back-office role. This is a position at the heart of drug development , where your fingerprints are on every clinical trial we run. So, what will you actually be doing? Think of yourself as the guardian of clarity and consistency across BMS's global clinical trial portfolio. You'll own the Model Documents that underpin Study Protocols - ensuring they're always current, always compliant, and always ready for whatever regulators, investigators or health authorities need to see. Here's what that looks like day-to-day: You'll be the expert in the room. When colleagues across Drug Development, Regulatory, Legal, Safety, Medical Affairs and beyond need guidance on clinical trial documentation standards, they'll turn to you. You'll develop a deep mastery of ICH guidelines, GCP requirements and industry standards and translate that expertise into documents people can actually use. You'll collaborate across the whole enterprise. This role connects you with virtually every function in R&D. From IT to Translational Medicine, from outsourcing teams to CROs and external partners - you'll build relationships and influence decisions across geographies and disciplines. If you thrive on variety and cross-functional energy, you'll love this. You'll represent BMS externally. You'll engage with industry bodies like TransCelerate, PhRMA and EFPIA, helping shape industry-wide standards - not just follow them. You'll align BMS's Model Documents with the TransCelerate Protocol Model Document, putting you at the forefront of industry collaboration. You'll be inspection-ready, always. Audits and health authority inspections won't phase you - you'll have built the processes and the documentation that make BMS shine when it matters most. That kind of contribution is visible, valued and career-defining. You'll help people grow. Partnering with the R&D Learning group, you'll ensure research teams across BMS are trained and confident in using these critical documents. There's real satisfaction in knowing you've upskilled an organisation. What's in it for you? Let's be direct about the tangible value this role brings to your career : Unmatched visibility - Reporting directly to the Head of the Clinical Design & Delivery Center, your work lands at the leadership level. Your impact is seen. Deep regulatory expertise - You'll build a rare, highly marketable knowledge base spanning GCP, ICH regulations, global health authority expectations and industry consortium standards. This is expertise that opens doors throughout your career in pharma. Cross-functional influence without the travel - You'll build a global network of stakeholders and partners across functions, geographies and external organisations - all without a suitcase. This role requires no travel, giving you the reach without the wear. Process ownership - You won't just execute; you'll design, implement and govern. That's the difference between a job and a craft. You'll own change control mechanisms, repository management and risk escalation processes end-to-end. A seat at the industry table - Engaging with bodies like TransCelerate means your voice contributes to standards that go beyond BMS. That's a résumé-builder and a purpose-driver in one. A culture that takes quality seriously - You'll work alongside a team that lives Quality by Design and Inspection Readiness - people who care as much as you do. And yes, we genuinely believe you can do all of this and have fun along the way. Is this you? You're probably a great fit if you: H


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