Director, Global Scientific and Regulatory Documentation, Content Strategy

BMS - Bristol-Myers Squibb

Warsaw, Poland

Position Summary

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.

Duties/Responsibilities

Work with Therapeutic Area Lead to optimize the delivery of content and documentation that supports the BMS pipeline;
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 for documents not covered adequately by in-house resources;
Review regulatory, clinical, and safety documentation according to:
- good documentation principles (organization, clarity, scientific standards);
- consistency between text and tabular presentations or graphical displays;
- compliance with BMS documentation standards and worldwide regulatory requirements.
Recruit and train scientific writers for this scope of documentation, as needed - Set clear performance standards, provides feedback and coaching, identifies and fulfills training needs, and holds the group members accountable for key deliverables. Provides performance evaluation input;
Support skillset development for scientific writers as needed for BMS pipeline, technological advancements, regulatory developments, and other opportunities;
Lead or contribute to innovation projects applying GenAI to automate and optimize regulatory writing processes;
Serve as a GenAI champion within GSRD;
Supports evolution of authoring workflows, standardization, and efficiency across documents;
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 for documents not covered adequately by in-house resources;
Ensure regular entry of meta data to support departmental metrics and analytics;
Influence other functions within BMS in matters pertaining to regulatory documentation processes and principles;
Develop 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. Develop 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.

Qualifications

PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with a minimum of 10 years in pharmaceutical regulatory documentation;
Prior regulatory documentation leadership in the development and approval of new drug applications/dossiers is preferred. All PhD in biological sciences and PharmD candidates are considered;
A proven record in managing group/project team with solid behaviors in cross-functional collaboration and communication;
Significant experience in writing high-quality regulatory documentation, including high-level summary documents (preferably clinical);
Experience in managing project teams and process workflows and exhibits solid behaviors in cross-functional collaboration and communication;
Experience in working in a rapidly changing environment where decisiveness, adaptability, and communication are critical to success;
Experience in mentoring and professional development of colleagues in a group;
Advanced understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities;
Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team;
Experience in the areas of state of the art documentation processes and technology.