Regulatory Writing Capability Lead

Responsibilities

• Accountable for GSC regulatory writing and study submission/approval capabilities.
• Carefully studies and develops/maintains expertise on regulatory writing technique and skills, study submission/approval environment, including monitoring guidance, advisory committees and other regulatory approval forums, as well as other pharmaceutical company s submissions/approvals.
• Uses external and internal insights to identify emerging trends and requirements and to inform, develop, and refine GSC and Lilly regulatory writing, content and study submission strategies
• Responsible for global onboarding/training programming for design and study development and provides leadership in implementation
• Develops close, cross-functional relationships with clinical development experts within Lilly. Collaborates and advises asset teams on study design, strategy, planning, execution, and best practices for critical study-related work, including incorporation of requirements.
• Serves as Subject Matter Expert within and outside of GSC on core business processes, procedures and applicable documents
• Process Owner for applicable regulatory writing and study processes
• Responsible for leading/managing functional initiatives
• May represent GSC in due diligence activities
• 2. Leads GSC design and study capability excellence:
• Serves as GSC representative in clinical design and study initiatives
• With clinical study design counterparts and GSC study leads, helps drive submission and approval capabilities and operational excellence globally, with a focus on design and study strategy and optimized documents that deliver focused messages and meet current agency and competitor standards.
• Responsible for monitoring and continually improving capabilities by working closely with study teams and observing processes and outcomes throughout study design, regulatory response, and study implementation periods (including management review as appropriate)
• Defines, collects, analyzes and acts on key metrics
• Collaborates across GSC Regulatory Capability space
• 3. External industry engagement/influence:
• Serves as Lilly representative to and plays leadership role in external forums such as PhRMA (Pharmaceutical Research and Manufactures of America), EFPIA (European Federation of Pharmaceutical and Industries), DIA (Drug Information Association), or TransCelerate.
• Involved in the development of industry standards through collaborations with external organizations, professional societies, regulators, vendors, etc.
• Participates in external initiatives to foster trust and respect among external stakeholders
• 4. People Management and Development, as applicable
• Leads a team of experts
• Recruits, develops, and retains a strategic and operationally capable workforce skilled and knowledgeable in regulatory writing and study development strategy
• Effectively creates and manages an agile organization that continuously meets the needs of a changing portfolio.
• Builds an organizational culture aligned with Team Lilly - inclusion, innovation, acceleration, delivery, integrity, excellence, and respect for people.
• Develops staff who demonstrate expertise in drug development, therapeutic area science, strategic thinking, project management, and cross-functional leadership.
• Provide input on employee development, talent assessment, and succession planning activities.
• Develops an organizational talent base that demonstrates judgment-based decision making.
• Provides guidance, training, and supervision to personnel
• Appropriately manage the workload of direct reports; monitor project timelines and quality and communicate priorities to direct reports
• Provide technical support and guidance to direct reports as needed
• Evaluates performance by reviewing documents and attending writing team meetings and recommends developmental actions for all assigned staff
• Ensure all direct reports are compliant with company policies, procedures, and regulations
• Participates in GSC functional recruiting efforts

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.