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Associate - Medical Affairs Uk Tmr

3+ years
Not Disclosed
10 Jan. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: UK Technical Medical Reviewer
Location: LCCI, Bangalore, India
Minimal Travel Expected (<10%)

At Lilly, we unite caring with discovery to improve lives globally. We are a leading global healthcare company based in Indianapolis, Indiana, and we are committed to developing life-changing medicines, advancing disease management, and supporting communities worldwide. Our efforts are driven by the passion of our people, and we prioritize making life better for people everywhere.

Job Overview

The UK Technical Medical Reviewer plays a vital role within the Promotional Material Approval Process (PMAP) by reviewing and approving the medical content of promotional materials to ensure compliance with regulatory requirements and industry standards. This role works closely with UK brand teams, medical advisors, and medical certifiers to ensure that materials meet the highest standards of medical accuracy, regulatory adherence, and scientific integrity. The Technical Medical Reviewer is integral to ensuring that Lilly’s promotional materials are not only compliant but also convey accurate, balanced, and scientifically sound messages to healthcare professionals.

This position reports to a manager within LCCI with a dotted line to the Senior Director of Operations in the Northern European (NE) Hub and will be involved in key business initiatives such as process improvements, training, and providing strategic leadership for transformation projects.

Key Responsibilities

1. Review and Approval of Promotional Materials:

  • Review detailed medical content in promotional materials, ensuring it aligns with regulatory documents (e.g., Summary of Product Characteristics and Prescribing Information) and scientific literature such as peer-reviewed journals and abstracts.
  • Ensure claims and data presented are scientifically accurate and reflect the strength and weaknesses of the supporting data.
  • Check visual and data representations for accuracy, ensuring they fairly convey results.
  • Ensure compliance with the UK ABPI and Irish IPHA Codes, including balance in efficacy and safety claims.
  • Review the metadata, referencing, and legal requirements (e.g., trademarks, privacy statements, GDPR compliance).
  • Verify that language, grammar, spelling, and style follow Lilly's Brand Book and product guidelines.

2. PMAP Process Management and Continuous Improvement:

  • Collaborate with cross-functional teams (marketing, medical) to ensure materials are compliant and accurate.
  • Provide training to new hires on the PMAP process and quality systems.
  • Monitor day-to-day quality, making recommendations for improvements to the PMAP process.
  • Track process efficiency, utilizing Lean and Six Sigma principles to eliminate bottlenecks and improve workflows.
  • Produce and present metrics and insights to senior leadership, identifying capacity and quality issues, and recommending improvements.

3. Data Analysis and Process Improvement:

  • Lead efforts to identify areas for process improvement using data analysis.
  • Work with UK leadership to update and maintain PMAP procedures, job aids, and guidelines.
  • Create actionable insights and strategic reports for UK leadership, supporting data-driven decision-making.
  • Share best practices and process improvements cross-functionally across brand teams.

4. Strategic Leadership and Transformation Initiatives:

  • Lead strategic initiatives aimed at transforming processes and improving PMAP efficiency.
  • Work with cross-functional teams to implement process changes and measure their impact on productivity.
  • Support brand teams during pre-launch activities to mitigate risks and ensure compliance.

Minimum Experience/Personal Skill Requirements:

  • At least 3 years of experience as an editor, copywriter, or proofreader, preferably within the pharmaceutical industry.
  • Strong collaboration and communication skills, with the ability to work effectively across teams.
  • Proven ability to prioritize, handle multiple tasks, and make decisions within the scope of responsibility.
  • Strong attention to detail and commitment to quality.
  • Ability to work independently, managing responsibilities and solving problems proactively.

Additional Preferences:

  • Familiarity with Veeva Vault PromoMats and other content management systems.
  • Experience with data analysis and process optimization, particularly using Lean or Six Sigma principles.
  • Master’s degree or equivalent experience in a scientific discipline.

Location and Travel:

  • Location: LCCI, Bangalore, India.
  • Minimal Travel Expected (<10%).

Equal Opportunity Employer:

Lilly is committed to providing equal opportunities for individuals with disabilities to actively engage in the workforce. If you need accommodation during the application process, please complete the accommodation request form here.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

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