Senior Director, Global Scientific and Regulatory Documentation, Content Strategy

Requirements

• A proven record in managing group/project team with exemplary behaviors in cross-functional collaboration and communication.
• Extensive experience in writing and overseeing high-quality regulatory documentation, including high-level summary documents (preferably clinical).
• Significant experience in managing project teams and pro

Additional Information

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 . Position Summary Leads the establishment and ongoing development of a Therapeutic Area (TA) team of scientific writers. Demonstrates in-depth expertise in the relevant TA and specific assets, enabling effective leadership in the creation of content libraries when warranted. Applies advanced regulatory documentation skills to guide and/or support the implementation of new processes, tools, and continuous improvements within the scope of departmental responsibilities. Demonstrates strong managerial, scientific, and customer-focused leadership skills. Applies regulatory documentation standards that enhance efficiency and ensure consistency across the entire development and life cycle management of TA assets, across geographic regions. Leads strategic planning for document automation and leads innovative initiatives to support those goals. The person in this role will be required to report to the Lawrenceville location. Duties/Responsibilities Work with Head of GSRD and direct reports to develop and lead the TA writing teams in support of global regulatory documentation for the BMS R&D goals and objectives. Establish strategic partnerships with other functions within BMS to maintain fully integrated and standardized processes and systems and ensure alignment of roles and responsibilities to meet BMS R&D objectives and priorities. Establish and maintain documentation standards, templates, and best work practices that are consistent with internal and external guidelines for regulatory documentation and submissions; facilitate the development of innovative solutions to resolve issues. Lead scientific writers in producing high-quality strategically written documents based on good documentation practices within established optimum timelines. Seek talent from across the industry and within BMS to help maintain a diverse, high-performing group. Assess resource requirements for all projects, assign resources according to BMS R&D priorities, and prepare criteria and strategies for the selection and maintenance of external documentation support (if applicable) for documents not covered adequately by in-house resources. Review regulatory, clinical, and safety documentation according to good documentation practices (organization, clarity, scientific standards), to establish consistency of content within TA and asset, and compliance with BMS documentation standards and worldwide regulatory requirements. Support skillset development for scientific writers as needed for BMS pipeline, technological advancements, regulatory developments, and other opportunities. Enable the group to proactively identify and take advantage of career development opportunities. Ensure regular entry of data to support departmental metrics and analytics. Influence other functions within BMS in matters pertaining to regulatory documentation processes and principles. Serve as process owner, lead, or subject matter expert as needed. Lead the development of training on regulatory documents from a variety of disciplines and provide to writers regardless of reporting relationship in matters pertaining to documentation processes and principles. Lead the development of resources for writing team to ensure quality standards. Facilitate proactive sharing of knowledge and key learnings within the group and across other functions. Interface across multiple functions to mediate conflict resolution, and champion an organizational culture to promote behaviors that lead to meaningful synergies and superior business performance. Represents BMS at industry and professional meetings to maintain knowledge of evolving industry standards and trends. Reports to the Executive Director, Global Scientific and Regulatory Documentation

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