Associate - Medical Affairs UK TMR

• The UK Technical Medical Reviewer works closely with UK brand teams within PMAP (Promotional Material Approval Process), reporting to a manager within LCCI but with a dotted line to the Senior Director of Operations within the Northern European (NE) Hub
• 
  The purpose of the Technical Medical Reviewer role is to review and approve the detailed medical content of promotional materials to ensure that they are in line with the regulatory documents (Summary of Product Characteristics and Prescribing Information), SOPs, references such as peer reviewed journals, abstracts, posters and other scientific literature, PMAP requirements and aspects of the UK ABPI and Irish IPHA Codes (external requirements)
• This review is completed in collaboration with the cross-functional brand teams and other internal and external stakeholders
• 
  The responsibility of the Technical Medical Reviewer is equivalent to the detailed medical review role of Medical Advisors in other affiliates such as in the Nordic countries
• The Medical Certifiers (Lilly and external agency staff) rely on the review and approval of the Technical Medical Reviewer and are not expected to check their work
• In the event of an external Code complaint or internal monitoring finding, the Technical Medical Reviewer would be held accountable for the information they have reviewed and approved
• 
  In addition to the main review role, the Technical Medical Reviewer will also be involved in many other areas as per business requirements such as delivering training to new hires from marketing or medical teams; drafting / owning PMAP documents; outlining PMAP guidelines, determining corrective actions to eliminate bottlenecks and prevent reoccurring issues; sharing best practices cross-functionally; leading workstreams in the continuous improvement and design of key processes, including proactively identifying potential implications and barriers prior to implementation of key process changes; mining and analyzing data sources; providing support for data-driven decisions by identifying patterns and trends in data sets; creating actionable insights and strategic reports for UK senior leadership such as the General Manager; and leading initiatives around defining metrics and best practices
• 
  This role will also provide strategic leadership and support to transformation initiatives; lead implementation of process changes; and measure and track process efficiency for maximum productivity and minimal waste

Key Objectives/Deliverables:

Review and approve the detailed medical content of promotional materials in Veeva Vault PromoMats (VVPM), working proactively and efficiently with the brand team, medical advisors and medical certifiers within and outside the brand s pre-Veeva meeting, considering the aspects below and applying these consistently during the job bag/tactic review and approval process:
Review the material for overall medical accuracy
Check that all statements and claims within the material are in line with the regulatory documents (Summary of Product Characteristics and Prescribing Information) and appropriate up-to-date references such as peer reviewed journals, abstracts, posters, guidelines, data-on-file and other scientific literature that contain clinical information, study design, patient population, endpoints, p values, statistical significance, graphs and other information
Ensure medical/scientific content is interpreted and used accurately and appropriately for the intended audience
Check that visual representations of the data accurately convey the meaning/results of the data
Check that all data values match the source documentation provided, and are also consistently used throughout the document sections, charts, legends, and footnotes
Check that all aspects of the promotional materials are aligned with the Promotional and Educational SOP, PMAP Job Aid and specific PMAP Guidance requirements for different tactic types
Ensure presentation of product data fairly reflects the overall strengths and weaknesses of the supporting data, considering aspects of the UK ABPI and Irish IPHA Codes (external requirements) such as the balance of efficacy/safety (80:20)
Check other aspects of the external Code such as correct inclusion and placement of black triangle, prescribing information, adverse event reporting statements, job bag code, date of preparation and copyright and confidentiality clauses
Review the metadata requirements such as Purpose, Name, Details (Method of Dissemination Audience, Permission Managed Content), Product Information, Country approved for Use (ensuring that it matches Prescribing Information (UK or Ireland) under Brexit)
Check PMAP legal requirements such as correct registered trademark symbol (R or TM), statements around privacy, confidentiality, copyright and terms and conditions as required
Check referencing nomenclature (usually Vancouver)
Check GDPR requirements such as consent and unsubscribe links
Check the material against style guides such as Lilly Brand Book and Product guidelines
Review and correct language, spelling and grammar

Participate in executing, monitoring, and continuous improvement of the UK PMAP Process:
Deliver functional training to new hires in the marketing and medical teams during the onboarding process
Provide coaching and training sessions as necessary to influence consistent implementation of changes
Support the learning plan process for new hires or for updates
Provide day-to-day quality oversight, including as Veeva Vault PromoMats Point of Contact (POC) which involves approvals of changes to job bag status or information.
Produce metrics presentations with insights and commentary for the Hub Leadership Team including the General Manager, COO and Business Unit Leads for review at the quarterly PMAP meetings
Produce monthly metrics, insights and commentary for UK leadership to highlight issues with capacity and/or quality
Review and provide feedback on proposed procedures for clarity, understanding, and ability for implementation
Enhance aspects of the quality system by anticipating compliance gaps and proactively proposing solutions through PMAP Guidance

Identify, analyze, and implement process improvement opportunities employing data analysis and process improvement methodologies:
Work with UK leadership to draft, own and update the PMAP Procedure, PMAP Job Aid and PMAP Guidance documents including process outlines, flowcharts, and implementation procedures for process changes
Participate in the continuous improvement and design of key processes, including proactively identifying potential implications and barriers prior to implementation of key process changes
Create actionable insights and strategic reports for UK leadership
Eliminate bottlenecks, variations, and redundant steps and procedures within the workflow using Lean and Six Sigma principles
Collect, analyze, interpret and disseminate Data Quality Metrics (DQM) and data for optimizing processes and workflows
Provide support for data-driven decisions by identifying patterns and trends in data sets to find areas of improvement and help UK leadership to make informed decisions
Lead initiatives around defining best practices for UK teams through documentation, validation, and dissemination
Share best practices cross-functionally and across brands
Mine and analyze data and dashboards to provide insights on the performance of PMAP and to prevent compliance findings
Lead initiatives around defining and refining metrics and best practices
Measure and track process efficiency for maximum productivity and minimal waste to increase speed and efficiency in the creation and approval of promotional materials.
Lead efforts of cross-functional collaboration to define and manage overarching goals of NE Hub brand teams:
Provide strategic leadership and support to transformation initiatives
Lead initiatives around defining best practices and process improvement methods for PMAP through documentation, validation, and dissemination
Lead implementation of process changes
Think strategically to identify potential implications and highlight barriers prior to implementation of key process changes relating to initiatives within PMAP
Participate actively in Six Sigma workstreams and collaborate cross-functionally to help design and improve workflow and processes for teams within PMAP
Work closely with the brand teams and medical certifiers on pre-launch activities to ensure that the risk is appropriately managed

Minimum Experience/Personal Skill Requirements:
At least 3 years of experience as an editor, copywriter, or proofreader
Demonstrated initiative and ability to influence, collaborate, and work on cross-functional teams
Ability to make decisions within scope of responsibility
Proven learning agility and proactivity
Demonstrated ability to prioritize and handle multiple concurrent tasks
Strong attention to detail
Additional Preferences:
Strong self-management/motivation, strong curiosity skills with the ability to anticipate problems, and provide potential solutions and work to resolution
Skilled at analysis, judgment and decision making, with an eye toward quality and continuous improvement
Proven planning and organizational skills
In-depth familiarity with Veeva Vault PromoMats
Education Requirements: