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The Executive Director, Global Scientific and Regulatory Documentation (GSRD) reports directly to the Vice President, Global Regulatory Strategic Operations (GRSO) and is a member of the GRSO Leadership Team. As such, this position has accountabilities for the sustained health, growth and continuous improvement of the GRSO organization, inclusive of developing effective partnerships with critical stakeholders across the BMS enterprise. This role will drive the long-term vision of scientific writing, sets the strategic direction and is accountable for delivering all global scientific writing deliverables in line with BMS strategy. She / he champions BMS people strategy and creates a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities optimizing their effectiveness to enable the timely and quality of global submissions. She / he has enthusiasm for digital innovation, and a history of successfully leading change initiatives with both internal and external partners.
Key responsibilities:Sets strategic vision for the department, and establishes the structure/organization / operating model for the department to successfully execute on high-quality deliverables across all programs in the companyFacilitates the development of innovative solutions to address/resolve potential issues.Creates a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities optimizing their effectiveness to enable the timely and quality of global submissionsLeads, mentors, and guides development of talent within GRSD and the broader organizationWorks effectively with cross-functional groups ensure the production of high-quality, scientifically accurate documents under aggressive timelines, and ensures consistency between related documents and among scientific writersLeads cross-functional project/initiatives that impact the company on a global scaleManages internal staffing and performance management, including hiring, training, coaching and performance reviews.Develop / adjusts operating models to ensure delivery of high quality, fit-for-purpose documentation and support pipeline accelerationImplements regulatory documentation standards that support speed and consistency of regulatory submissions across all full development / life cycle management assets and geographies.Proactively addresses business need, prioritization of regulatory submissions, and allocates resources to meet strategic BMS R&D submission goals.Influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship in matters pertaining to documentation processes and principles.Engages / presents at external forums
Requirements:PhD/MD/PharmD or commensurate with experience including thorough understanding of drug development and scientific principles and at least 7 years of organizational leadershipOrganizational leadership experience driving complex and diverse deliverables meeting R&D objectives with the ability to inspire and mentor a diverse and global team.Extensive experience in team management at the department level; with proven ability to manage large change initiatives successfully.Proven track record in the delivery of successful major filings (NDA / MAA / J-NDA / China NDA), preferably in different therapeutic areas strong depth and breadth of knowledge of the submission process and significant experience in writing highlevel summary documents for global registrations; experience in process development and preparation of key regulatory documentation such as protocol development, clinical study report, Investigator Brochure, and safety aggregate reportingBroad intelligence of regulatory environment across key regions, anticipation of future trends and impactExcellent cross functional communications skills and a decisive yet collaborative leadership style to drive results while managing relationships.Strong influencing/persuasive skills with a demonstrated ability to influence different styles and individuals at different levels in organization.Strong collaboration and analytical skills to ensure that emerging trends are well assessed and vetted for potential business implications.Proven track record for implementing innovative solutions and continuous improvement with appropriate risk taking.
Key Competency Requirements:Creates a sense of purpose or vision for self, department and leadership team.Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.Strong leadership in a matrix organization with strong interpersonal skills; Solid organizational skills and ability to work independently with limited direction are key.Translates broad strategies into specific objectives and action plans.Sets challenging, but achievable objectives.Generates alternatives and assesses benefits and risks.Allocates resources according to strategic priorities.Makes critical choices that support strategy and ultimately the end-customer.Aligns personal, team and/or department goals and objectives with organization goals and business strategy and takes actions to achieve them.Thinks Strategically - Sets direction aligned to the company's strategy, applying external and global perspective to meet local and global needsCommunicates opinions, facts and thoughts with clarity, transparency and honesty.Seeks multiple perspectives and listens openly to others' points of views.Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.Creates an environment that encourages continuous improvement, innovation and appropriate risk taking.Focuses organization on key priorities that impact our business.Adapts to and/or drives positive change.Removes barriers and eliminates non-value added work.Demonstrates resilience and perseverance.Continuously builds a high-performance diverse team of people to achieve objectivesDevelops self and others to improve performance in current role and to prepare for future roles.Seeks and welcomes feedback and responds to coaching.Provides frequent feedback and coaching to others on ways to improve performance
If you come across a role that intrigues you but doesn't 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.
Uniquely Interesting Work, Life-changing CareersWith 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 an inclusive culture, promoting diversity 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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