Associate - Medical Affairs Uk Tmr

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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 mínimal waste.

Key Objectives/Deliverables:

- 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, confidentialit