Bristol Myers Squibb
Pharmaceutical
Director,GlobalScientificandRegulatoryDocumentation,ContentStrategy
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“Director, Global Scientific and Regulatory Documentation, Content Strategy at Bristol Myers Squibb. Skills: Regulatory documentation, Content strategy, GenAI automation. Support establishment and development of scientific writers. Guide writer assignments and development plans”
What You'll Achieve.
Support BMS pipeline; Support quality and content flow; Support superior business performance
Industry & Context.
What They're Looking For.
Must Have
PharmD/PhD/MD in relevant scientific discipline, Master's/Bachelor's degree with 10 years pharmaceutical regulatory documentation, Proven record managing group/project team, Significant experience writing high-quality regulatory documentation, Experience managing project teams and process workflows, Experience working in rapidly changing environment, Experience mentoring and professional development of colleagues, Advanced understanding of global pharmaceutical drug development, Demonstrated ability to manage timelines and quality, Experience in state of art documentation processes and technology
Nice to Have
Prior regulatory documentation leadership in development and approval of new drug applications/dossiers
What You'll Do.
Support establishment and development of scientific writers
Guide writer assignments and development plans
Mentor scientific writers
Create and implement process improvements
Optimize content and documentation delivery
Assess resource requirements for projects
Assign resources according to R&D priorities
Prepare criteria for external documentation support
and safety documentation
Recruit and train scientific writers
Set clear performance standards
Provide feedback and coaching
Identify and fulfill training needs
Hold group members accountable
Provide performance evaluation input
Support skillset development for scientific writers
Lead innovation projects applying GenAI
Automate and optimize regulatory writing processes
Serve as GenAI champion
Support evolution of authoring workflows
Ensure regular entry of meta data
Influence other functions in regulatory documentation
Develop training on regulatory documents
Provide training to writers
Develop resources for writing team
Facilitate proactive knowledge sharing
Interface across multiple functions
Mediate conflict resolution
Champion organizational culture
How You'll Work.
Team & Collaboration
Cross-functional teams; Therapeutic Area Lead; External documentation support; Across multiple functions
Communication Scope
Cross-functional communication; Interpersonal skills
Process & Methodology
Project team management, Process workflows
Full Job Description
**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](https://careers.bms.com/working-with-us). _Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley._ Supports the establishment and ongoing development of team of scientific writers working across therapeutic areas. Guides writer assignments and development plans, and mentors scientific writers in a variety of content and document assignments. Takes initiative to create and implement process improvements and behavioral changes that support the quality and content flow of information supporting the BMS pipeline. * Work with Therapeutic Area Lead to optimize the delivery of content and documentation that supports the BMS p
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