Associate - Medical Affairs Uk Tmr

3+ years

Not Disclosed

Bengaluru

10 Jan. 29, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate - Medical Affairs UK TMR
Location: Bangalore, Karnataka, India
Category: Medical
Job Type: Full Time, Regular
Job ID: R-76732

About Lilly

At Lilly, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global healthcare leader. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. We are committed to putting people first and delivering our best work. We are looking for individuals who share our determination to make life better for people worldwide.

Position Summary

The UK Technical Medical Reviewer is a key member of the Medical Affairs team, supporting the UK brand teams within the Promotional Material Approval Process (PMAP). Reporting to a manager within LCCI, the role will also have a dotted line to the Senior Director of Operations within the Northern European (NE) Hub.

The primary responsibility of the Technical Medical Reviewer is to ensure the medical accuracy of promotional materials by reviewing and approving the detailed content. This includes verifying that all claims and statements are in line with regulatory documents (e.g., Summary of Product Characteristics, Prescribing Information), SOPs, references (peer-reviewed journals, abstracts, posters), and codes such as the UK ABPI and Irish IPHA Codes. This role works closely with cross-functional teams and other stakeholders to ensure compliance with internal and external requirements.

Key Responsibilities

Review and Approve Promotional Materials:
- Ensure medical accuracy in all promotional materials reviewed in Veeva Vault PromoMats (VVPM).
- Validate that content aligns with regulatory documents (SPC, Prescribing Information) and up-to-date references.
- Ensure the accuracy of data presentation, including statistical significance, graphs, and claims related to clinical trials and product information.
- Verify compliance with UK ABPI and Irish IPHA Codes, ensuring balanced representation of efficacy and safety.
- Ensure inclusion of appropriate legal and regulatory elements (e.g., black triangle, adverse event reporting, copyright statements, GDPR compliance).
- Maintain consistency in referencing, spelling, grammar, and style according to Lilly Brand and Product guidelines.
Process Execution and Improvement:
- Contribute to the continuous improvement of the UK PMAP process, including training new hires in marketing and medical teams.
- Oversee day-to-day quality assurance for Veeva Vault PromoMats (POC) and ensure compliance with process requirements.
- Create and analyze metrics reports to support leadership decision-making, including quarterly and monthly updates on capacity, quality, and process improvement.
- Proactively identify process inefficiencies and contribute to the development of actionable solutions.
Cross-Functional Collaboration:
- Collaborate with cross-functional teams, including brand teams, medical advisors, and medical certifiers, to ensure seamless execution of the PMAP process.
- Provide strategic leadership in transformation initiatives, supporting process changes and identifying potential barriers before implementation.
- Lead Six Sigma workstreams and cross-functional teams to enhance workflow efficiency and reduce waste.
Data Analysis and Reporting:
- Collect, analyze, and disseminate data to optimize processes and workflows, with a focus on improving process efficiency.
- Identify patterns and trends in data to inform decision-making and improve PMAP processes.
- Lead initiatives to define and refine metrics, and share best practices across teams.

Minimum Qualifications

Education: Master's degree or equivalent experience in a scientific discipline.
Experience: At least 3 years of experience in roles such as editor, copywriter, or proofreader.
Skills:
- Strong attention to detail and ability to work under pressure with multiple concurrent tasks.
- Ability to influence and collaborate effectively with cross-functional teams.
- Experience with data analysis and process improvement methodologies.
- Familiarity with Veeva Vault PromoMats and regulatory compliance processes.
- Strong communication, training, and coaching abilities.
- Proven ability to prioritize tasks and manage time effectively.

Preferred Qualifications

Strong self-management and problem-solving skills with an ability to proactively identify solutions.
Experience in quality control, compliance, and process efficiency improvements.
Proficiency in Lean and Six Sigma principles.
Familiarity with the UK and Irish pharmaceutical industry regulations.

Additional Information

Location: LCCI, Bangalore
Travel: Minimal (<10%)

Lilly is committed to diversity and inclusion and offers equal employment opportunities to all qualified individuals. We encourage individuals with disabilities to request accommodations if needed during the application process.

How to Apply

Interested candidates can submit their resumes via the Lilly Careers website.

Lilly is an equal opportunity employer and adheres to all laws and regulations regarding workplace accommodations and equal opportunities.

#WeAreLilly

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