LCCI Team Lead – Medical Affairs Quality
4 weeks ago
We’re looking for people who are determined to make life better for people around the world.
Purpose:
Organization Background
Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals (HCPs), payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.
As HCPs are deluged with data and are making choices in an increasingly complex and stressed health system, Lilly Medical Affairs (MA) can provide clear, credible answers that will set Lilly apart from its competitors. MA mission is to make Lilly the preferred pharmaceutical partner in the healthcare community globally by leveraging its medical expertise to drive patient-centric answers and solutions. MA brings deep medical expertise to HCPs and payers and focuses on answering HCP questions with customized clinical and real-world evidence that can make the difference on if and how they use Lilly products. Additionally, MA brings clinical insights from customers back to Lilly to inform new product development and lifecycle planning. MA also supports patients with educational tools to help them manage their illness and with assistance to access our medicines for those facing tough financial situations.
The purpose of the Medical Affairs (MA) Quality- Team Lead’s role is to
Collaborate with deliverable teams and other internal and external stakeholders to provide oversight of the deliverable review lifecycle to ensure tactics (promotional and/or medical) adhere to Customer Information Quality (CIQ), Medical Content Approval (MCA), and Permission Managed Content (PMC) requirements and corresponding process requirements.
Leverage content, project, and quality management tools to increase speed and efficiency while ensuring quality review/approval of all materials. He/she/they will manage the agile needs of the changing portfolio; lead implementation of process changes; and measure and track process efficiency and quality for maximum productivity while maintaining quality.
Lead capacity planning for the Medical Affairs Quality LCCI Team through data-driven decisions by collecting, mining, and analyzing of data sources; identifying patterns and trends in data sets; leveraging business intelligence and analytics (BI&A) tools to create actionable insights and strategic reports for leadership and LMS / LCCI L-MACH teams; and leading initiatives around defining metrics and best practices.
Seek to understand and eliminate process bottlenecks and reoccurring issues; sharing best practices cross-functionally; and participate in continuous improvement and design of key processes, including proactively identifying potential implications and barriers prior to implementation of key process changes.
Be responsible for people management, training, and development; strategic leadership and organizational effectiveness to support to transformation initiatives; and work closely with Directors and Team Leads across LCCI Medical Affairs and LMS to ensure best practices across the function.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
1.Subject Matter Expert for Lilly’s procedures, processes, tactic types, and support resources
Understand Lilly’s culture, Medical Affairs and Marketing organizational structures, roles and responsibilities, including how both fit into the bigger picture of Medical Affairs / Marketing Services and Lilly organization Have a thorough understanding of Lilly’s quality requirements and processes (i.e., CIQ and MCA requirements) and must be capable of understanding and applying these requirements/processes when executing their role Model strong knowledge ofmedical and marketing tactic types and associated requirementsmedical and marketing tactic lifecycleexternal agency structures and processessystems, software, tools, and Supervisor resourcesthe healthcare environment and regulated industry practices Awareness of Lilly’s disease states and products Actively lead and/or participate in deviation investigations2.Ensure Quality, Speed, Value, and Compliance throughout the Deliverable Review Lifecycle
Follow organizational project management best practices Responsible/accountable for the oversight and delivery of assigned workConduct capacity planning and resourcingManage the agile needs of the changing portfolioDefine, execute, and monitor CIQ/MCA guidelines and systems supporting LCCI LMS and US Medical Affairs teams forIdentify continuous improvement of processes and quality systems, and implement process/procedure updates/changesUphold Lilly procedures and processesDetermine corrective actions to eliminate recurring issues and work with CIQ/MCA team in tracking and managing deviations Demonstrate ability to partner effectively with cross-functional colleagues and facilitate shared-learning forums to establish best practices and identify challenges across teams Measure and track process efficiency through defining metrics, analyzing data sources, and providing support for data-driven decisions by identifying patters and trends in data sets3.Coach, Manage, and Develop a Team
Recruits, develops, and retains a strategic and operational top talent Builds an organizational culturealigned with Team Lilly – inclusion, innovation, acceleration, delivery, integrity, excellence, and respect for people.Utilize myPM process to operationalize organizational goals. Provides guidance, training and supervision to personnel including the following:Manages new-hire onboarding process for staffDevelops and implements functional trainingEnables robust coaching processUtilizes Lilly coaching framework and partners with direct reports to create individual development planning/action planningServes as a trusted career advisor by provide input on employee development and talent assessments. Works with HR to identify career opportunities and participate in succession planning activities.Monitors employee engagement and team healthProvides technical support as neededEvaluates performance by conducting monitoring/audits.Ensures all direct reports are compliant with company policies, procedures, and regulations.Appropriately manage the workload of direct reports; monitors project timelines and quality; and ensures communication of priorities to direct reports.Minimum Qualification Requirements
3 years’ experience as an editor, copyrighter, or proofreader medical and/or marketing, communications, advertising agency, or pharmaceutical industry. 2 years’ experience in formal management experience Proven experience leading/managing a strategic portfolio or business process. Ability to coach, collaborate, influence, network, and work effectively while leading others. Experience in project management. Strong written and verbal communication skills in English. Proven problem-solving skills in a fast-paced environment. Skilled at judgement and decision making Formal and/or informal leadership/coaching experience Experience working in a regulated industry (e.g., pharma) Working with U.S. clients, especially pharma clientsEducational Requirements
Advanced degree such as master’s degree (e.g., MBBS, MPH); Professional degree (e.g., MD, PharmD, PhD).Other Information/Additional Preferences
In-depth familiarity with the US CIQ/MCA procedures, processes, and tools like Veeva, Global Vision, Wrike, Adobe Experience Manager (AEM), etc. Experience in budgeting and capacity resourcing. Knowledge of data analytics tools such as Power BI, Tableau, etc. Location: LCCI, Bangalore Minimal travel expected (-
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