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Associate - Medical Affairs Uk Tmr

3+ years
Not Disclosed
10 Dec. 17, 2024
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: Bengaluru, India
Job Type: Full-time
Posted On: 4 Days Ago
Job Requisition ID: R-76732

Company Overview:
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 across the globe are dedicated to discovering and delivering life-changing medicines to those in need, improving disease understanding, and giving back to communities through philanthropy and volunteerism. We are looking for individuals who are determined to make life better for people worldwide.

Job Summary:
The UK Technical Medical Reviewer is responsible for reviewing and approving the medical content of promotional materials within Lilly’s promotional material approval process (PMAP). This role works closely with UK brand teams, the Medical Affairs team, and other internal stakeholders, ensuring all promotional materials comply with regulatory standards and are medically accurate. The reviewer also contributes to the continuous improvement of the PMAP process and provides strategic leadership for process transformations.

Key Responsibilities:

Promotional Material Review:

  • Review and approve the medical content of promotional materials using Veeva Vault PromoMats (VVPM), ensuring compliance with the Summary of Product Characteristics, Prescribing Information, scientific literature, and external codes (UK ABPI, Irish IPHA).
  • Ensure medical/scientific content is accurate and aligned with regulatory guidelines.
  • Verify that promotional materials present product data accurately, including clinical trial results, patient populations, and endpoints, and adhere to Lilly's branding guidelines.
  • Ensure materials are compliant with GDPR, referencing nomenclature, and all legal and style requirements.

Process Improvement & Strategy:

  • Contribute to the continuous improvement of the PMAP process by identifying bottlenecks and implementing process changes.
  • Collect and analyze data metrics, providing actionable insights to UK leadership, such as the General Manager and Business Unit Leads.
  • Lead initiatives to define best practices, streamline workflows, and improve efficiency in the creation and approval of promotional materials.
  • Participate in cross-functional teams to drive the transformation of processes within the PMAP.

Training & Collaboration:

  • Deliver training to new hires in the marketing and medical teams on PMAP and regulatory requirements.
  • Coach and mentor teams to ensure consistent implementation of PMAP guidelines and process changes.
  • Foster cross-functional collaboration to ensure alignment in promotional material strategies and to address potential issues proactively.

Additional Responsibilities:

  • Provide quality oversight and ensure compliance with all relevant codes and internal requirements.
  • Lead efforts in process transformation and play a key role in driving the success of PMAP initiatives within the Northern European Hub.

Minimum Qualifications:

  • Master’s degree or equivalent experience in a scientific discipline.
  • At least 3 years of experience in editing, copywriting, or proofreading in the pharmaceutical industry.
  • Familiarity with Veeva Vault PromoMats and understanding of Good Clinical Practice (GCP).
  • Strong attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.
  • Strong communication and collaboration skills, with a demonstrated ability to influence teams and stakeholders.

Additional Preferences:

  • Proactive approach to problem-solving with the ability to identify and resolve issues efficiently.
  • Strong understanding of regulatory guidelines, including the UK ABPI and Irish IPHA Codes.
  • Previous experience in a similar medical review or promotional material approval role is highly preferred.

Other Information:

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

Equal Opportunity Employer:
Lilly is committed to creating an inclusive workplace for individuals with disabilities. If you need accommodation during the application process, please visit our Workplace Accommodation Request Form. Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.