Quality Medical Reviewer \u2013 Medical Affairs Quality

Location

Bangalore | India

Job description

LCCI Quality Medical Reviewer u2013 Medical Affairs Quality

(Title/level may vary by site or geographic location)

Purpose:u00A0

Organization Background

Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, healthcare professionals (HCPs), payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.

As HCPs are deluged with data and are making choices in an increasingly complex and stressed health system, Lilly Medical Affairs (MA) can provide clear, credible answers that will set Lilly apart from its competitors. MAu2019s mission is to make Lilly the preferred pharmaceutical partner in the healthcare community globally by leveraging its medical expertise to drive patient-centric answers and solutions. MA brings deep medical expertise to HCPs and payers and focuses on answering HCP questions with customized clinical and real-world evidence that can make the difference on if and how they use Lilly products. Additionally, MA brings clinical insights from customers back to Lilly to inform new product development and lifecycle planning. MA also supports patients with educational tools to help them manage their illness and with assistance to access our medicines for those facing tough financial situations.

Position Description

The purpose of the Quality Medical Reviewer role in Medical Affairs is to review and approve U.S. medical (non-promotional) and promotional materials to ensure they are medically accurate and interpreted correctly based on the review of references/citations and data available. The Quality Medical Reviewer is expected to provide scientific and clinical inputs while collaborating with cross-functional teams during the review and approval of content, including attending review meetings. The Quality Medical Reviewer should also be aware of and ensure that all tasks are in compliance with Lillyu2019s policies, procedures, SOPs and guidelines, and leverage different content, project, and quality management tools to increase speed and efficiency in the review and approval of promotional and medical (non-promotional) materials.

Primary Responsibilities:u00A0

This job description intends to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

u00A7 Know Lillyu2019s policies and procedures, and review promotional and medical (non-promotional) materials

• Thorough understanding of Lillyu2019s quality requirements and processes (i.e., CIQ and MCA requirements) and applying these guidelines consistently during the review process
• Verify all data values match the source documentation such as references provided, and are also consistently used throughout the document sections, charts, legends, and footnotes
• Verify visual representations of data accurately convey the meaning/results of the data
• Ensure data represents current knowledge and published scientific data
• Ensure information is presented in a clear, complete, accurate, and concise manner
• Ensure key data, statements, and conclusions are consistent across related documents, and statements and conclusions are integrated, accurate, balanced and supported by appropriate data
• Collaborate with cross-functional teams such as Marketing, Medical teams, etc. during the review, approval, and management of content, including attending review meetings as and when required
• Demonstrate working knowledge of therapeutic areas, products and disease state information, and familiarity with trial designs, rationale, and data
• Understand key priorities and communication strategies across therapeutic areas and/or organizational units
• Expertise in tools and platforms such as Veeva Vault, project planning software (e.g., Wrike, MS Project), etc.

u00B7 Ensure quality, speed, value, and compliance throughout the review process

• Understand and actively address questions related to clinical/medical/scientific content from cross-functional teams in a timely fashion
• Participate in the development and review of promotional and medical content in collaboration with brand teams, regulatory, copyeditors, etc.
• Responsible and accountable for the oversight and delivery of tasks
  • Upholding Lilly procedures and processes
  • Reviewing and approving materials in a timely manner
  • Determining corrective actions to eliminate recurring issues
  • Liaising with CIQ/MCA Lead and Operations teams in tracking and managing deviations
• Partner effectively with cross-functional colleagues and facilitate shared-learning forums to establish best practices and identify challenges across teams
• Offer scientific and medical input, and contribute to the development, review and approval of promotional and medical materialsu00A0
• Adhere to best practices based on Lillyu2019s internal standards

Minimum Qualification Requirements:u00A0

• 2-4 years of experience working as a scientific/medical editor, copywriter, copyeditor, promotional and medical (non-promotional) content for publishing, marketing, communications, advertising agency, or pharmaceutical industry
• Must have a good understanding of scientific/medical/statistical terminologies
• Demonstrated initiative and ability to influence, collaborate, and work on cross-functional teams and ability to make decisions within scope of responsibility
• Demonstrated ability to prioritize and handle multiple concurrent tasks with strong attention to detail, critical thinking, and analytical ability
• Excellent written and verbal communication skills
• Ability to work well independently or as part of a team, within and across culturally and geographically diverse environments
• Experience working in a regulated industry (e.g., pharma)

Additional Preferences

• In-depth familiarity with the US CIQ/MCA framework, procedures, processes, and tools like Veeva Vault, Wrike, etc.
• Experience in reviewing/writing Medical Affairs communications (slide decks, patient or HCP materials, etc.)
• Knowledge and experience specific to clinical pharmacology, therapeutic areas such as neuroscience, oncology, cardiovascular, immunology or endocrinology, or other medical and scientific fields

Educational Requirements:

• Bacheloru2019s or Masteru2019s degree in scientific, health, communications, technology health-related fields with formal research component

Other Information/Additional Preferences:

• Location:u00A0 LCCI, Bangalore

Job Description Version History:u00A0

Version Number

Description of Change

1.0

This is the initial release.

Job tags

Salary