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Job Description

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). u00A0This 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. u00A0The 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. u00A0In 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.u00A0
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.

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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 brandu2019s pre-Veeva meeting, considering the aspects below and applying these consistently during the job bag/tactic review and approval process:u00A0
u2022u00A0u00A0 u00A0Review the material for overall medical accuracy
u2022u00A0u00A0 u00A0Check 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 informationu00A0
u2022u00A0u00A0 u00A0Ensure medical/scientific content is interpreted and used accurately and appropriately for the intended audience
u2022u00A0u00A0 u00A0Check that visual representations of the data accurately convey the meaning/results of the datau00A0
u2022u00A0u00A0 u00A0Check that all data values match the source documentation provided, and are also consistently used throughout the document sections, charts, legends, and footnotes
u2022u00A0u00A0 u00A0Check 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 typesu00A0
u2022u00A0u00A0 u00A0Ensure 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)
u2022u00A0u00A0 u00A0Check 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
u2022u00A0u00A0 u00A0Review 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)
u2022u00A0u00A0 u00A0Check PMAP legal requirements such as correct registered trademark symbol (R or TM), statements around privacy, confidentiality, copyright and terms and conditions as required
u2022u00A0u00A0 u00A0Check referencing nomenclature (usually Vancouver)
u2022u00A0u00A0 u00A0Check GDPR requirements such as consent and unsubscribe links
u2022u00A0u00A0 u00A0Check the material against style guides such as Lilly Brand Book and Product guidelines
u2022u00A0u00A0 u00A0Review and correct language, spelling and grammar

Participate in executing, monitoring, and continuous improvement of the UK PMAP Process:
u2022u00A0u00A0 u00A0Deliver functional training to new hires in the marketing and medical teams during the onboarding processu00A0
u2022u00A0u00A0 u00A0Provide coaching and training sessions as necessary to influence consistent implementation of changesu00A0
u2022u00A0u00A0 u00A0Support the learning plan process for new hires or for updates
u2022u00A0u00A0 u00A0Provide 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.u00A0
u2022u00A0u00A0 u00A0Produce 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
u2022u00A0u00A0 u00A0Produce monthly metrics, insights and commentary for UK leadership to highlight issues with capacity and/or qualityu00A0
u2022u00A0u00A0 u00A0Review and provide feedback on proposed procedures for clarity, understanding, and ability for implementation
u2022u00A0u00A0 u00A0Enhance 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:
u2022u00A0u00A0 u00A0Work 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
u2022u00A0u00A0 u00A0Participate in the continuous improvement and design of key processes, including proactively identifying potential implications and barriers prior to implementation of key process changesu00A0
u2022u00A0u00A0 u00A0Create actionable insights and strategic reports for UK leadershipu00A0
u2022u00A0u00A0 u00A0Eliminate bottlenecks, variations, and redundant steps and procedures within the workflow using Lean and Six Sigma principles
u2022u00A0u00A0 u00A0Collect, analyze, interpret and disseminate Data Quality Metrics (DQM) and data for optimizing processes and workflows
u2022u00A0u00A0 u00A0Provide 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
u2022u00A0u00A0 u00A0Lead initiatives around defining best practices for UK teams through documentation, validation, and disseminationu00A0
u2022u00A0u00A0 u00A0Share best practices cross-functionally and across brands
u2022u00A0u00A0 u00A0Mine and analyze data and dashboards to provide insights on the performance of PMAP and to prevent compliance findings
u2022u00A0u00A0 u00A0Lead initiatives around defining and refining metrics and best practices
u2022u00A0u00A0 u00A0Measure and track process efficiency for maximum productivity and minimal waste to increase speed and efficiency in the creation and approval of promotional materials.u00A0
Lead efforts of cross-functional collaboration to define and manage overarching goals of NE Hub brand teams:
u2022u00A0u00A0 u00A0Provide strategic leadership and support to transformation initiatives
u2022u00A0u00A0 u00A0Lead initiatives around defining best practices and process improvement methods for PMAP through documentation, validation, and disseminationu00A0
u2022u00A0u00A0 u00A0Lead implementation of process changes
u2022u00A0u00A0 u00A0Think strategically to identify potential implications and highlight barriers prior to implementation of key process changes relating to initiatives within PMAP
u2022u00A0u00A0 u00A0Participate actively in Six Sigma workstreams and collaborate cross-functionally to help design and improve workflow and processes for teams within PMAP
u2022u00A0u00A0 u00A0Work closely with the brand teams and medical certifiers on pre-launch activities to ensure that the risk is appropriately managedu00A0

Minimum Experience/Personal Skill Requirements:
u2022u00A0u00A0 u00A0At least 3 years of experience as an editor, copywriter, or proofreaderu00A0
u2022u00A0u00A0 u00A0Demonstrated initiative and ability to influence, collaborate, and work on cross-functional teamsu00A0
u2022u00A0u00A0 u00A0Ability to make decisions within scope of responsibility
u2022u00A0u00A0 u00A0Proven learning agility and proactivity
u2022u00A0u00A0 u00A0Demonstrated ability to prioritize and handle multiple concurrent tasksu00A0
u2022u00A0u00A0 u00A0Strong attention to detail
Additional Preferences:u00A0
u2022u00A0u00A0 u00A0Strong self-management/motivation, strong curiosity skills with the ability to anticipate problems, and provide potential solutions and work to resolution
u2022u00A0u00A0 u00A0Skilled at analysis, judgment and decision making, with an eye toward quality and continuous improvement
u2022u00A0u00A0 u00A0Proven planning and organizational skills
u2022u00A0u00A0 u00A0In-depth familiarity with Veeva Vault PromoMats
Education Requirements:
u2022u00A0u00A0 u00A0Master's degree or equivalent experience in a scientific discipline
Other Information:u00A0
u2022u00A0u00A0 u00A0Location: LCCI, Bangalore
u2022u00A0u00A0 u00A0Minimal travel expected ( 10%)
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