Protocol Model Document Content Steward
Job Summary
Working with Us
Challenging. Meaningful. Life-changing. 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 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: 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 beprecise compliant and built to last. Thats where you come in.
At BMS were looking for aProtocol 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 thefoundation that keeps patients safe and science moving forward.
This isnt a back-office role. This is a position at theheart of drug development where your fingerprints are on every clinical trial we run.
So what will you actually be doing
Think of yourself as theguardian of clarity and consistencyacross BMSs global clinical trial portfolio. Youll own the Model Documents that underpin Study Protocols - ensuring theyre always current always compliant and always ready for whatever regulators investigators or health authorities need to see.
Heres what that looks like day-to-day:
- Youll 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 theyll turn to you. Youll develop a deep mastery of ICH guidelines GCP requirements and industry standards and translate that expertise into documents people can actually use.
- Youll 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 - youll build relationships and influence decisions across geographies and disciplines. If you thrive on variety and cross-functional energy youll love this.
- Youll represent BMS externally.Youll engage with industry bodies like TransCelerate PhRMA and EFPIA helping shape industry-wide standards - not just follow them. Youll align BMSs Model Documents with the TransCelerate Protocol Model Document putting you at the forefront of industry collaboration.
- Youll be inspection-ready always.Audits and health authority inspections wont phase you - youll 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.
- Youll help people grow.Partnering with the R&D Learning group youll ensure research teams across BMS are trained and confident in using these critical documents. Theres real satisfaction in knowing youve upskilled an organisation.
Whats in it for you
- Lets be direct about thetangible 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- Youll 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- Youll 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 wont just execute; youll design implement and govern. Thats the difference between a job and a craft. Youll 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. Thats a résumé-builder and a purpose-driver in one.
- A culture that takes quality seriously- Youll 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 thisandhave fun along the way.
Is this you
Youre probably a great fit if you:
- Have5 years in pharma with at least3 years in clinical trial operations or GCP- you know this world and youre ready to lead within it
- Hold aBachelors Degree(Life Sciences preferred) and bring a sharp detail-oriented mind to complex documentation challenges
- Are comfortable navigatingmatrix environments- you know how to influence without authority and bring people along with you
- Communicate clearly and confidently whether youre presenting to senior stakeholders negotiating with a vendor or resolving a process conflict constructively
- Have an appetite forcontinuous improvement- Lean Sigma experience is a bonus and a simplification mindset is a must
- Know your way around tools likeCARA Veeva ECLIPSE and SharePoint(or are ready to get up to speed quickly)
#LI-Hybrid
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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.
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 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.
On-site Protocol
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:
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.
Supporting People with Disabilities
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.
Candidate Rights
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: Protection
We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way please contact BMS at . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R: Protocol Model Document Content StewardAbout Company
Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more