Quality Medical Reviewer Job for MSc/ B.Pharm/ M.Pharm Candidates at Lilly

Lilly Hiring MSc/ B.Pharm/ M.Pharm Candidates for Quality Medical Reviewer Position

Lilly Hiring MSc/ B.Pharm/ M.Pharm Candidates for Quality Medical Reviewer Position.Lilly Hiring MSc/ B.Pharm/ M.Pharm Candidates.  Interested Candidates can check out the details below and Apply Online.

Job title: Quality Medical Reviewer – Medical Affairs Quality

Job Location: Bangalore, Karnataka, India Category

Job ID : R-41495

Job Type: Full Time

Purpose:

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. MA’s 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 Lilly’s 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:

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.

§Know Lilly’s policies and procedures, and review promotional and medical (non-promotional) materials

• Thorough understanding of Lilly’s 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.

·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 materials
• Adhere to best practices based on Lilly’s internal standards

Lilly Hiring MSc/ B.Pharm/ M.Pharm. Minimum Qualification Requirements:

• 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:

• Bachelor’s or Master’s degree in scientific, health, communications, technology health-related fields with formal research component

APPLY ONLINE 

Lilly Hiring MSc/ B.Pharm/M.Pharm Candidates for Quality Medical Reviewer Position. Here are five Possible interview questions and sample answers based:

Question 1: Can you explain your understanding of Lilly’s quality requirements and processes, such as CIQ and MCA requirements, and how you would apply these guidelines consistently during the review process?

Sample Answer 1: Lilly’s quality requirements, including CIQ (Clinical, Information, and Quality) and MCA (Medical Communications and Affairs), are critical in ensuring the accuracy and compliance of promotional and medical materials. I understand that CIQ and MCA requirements encompass rigorous standards for data accuracy, clarity, and compliance with regulations. To apply these guidelines consistently during the review process, I would meticulously verify that all data values match the source documentation, such as references provided, and are consistently used throughout the document. I would also ensure that visual representations of data accurately convey the meaning and results of the data. Moreover, I would review content to ensure it is presented in a clear, complete, accurate, and concise manner, consistent with Lilly’s quality standards.

Question 2: How do you prioritize and handle multiple concurrent tasks with strong attention to detail in a fast-paced environment, as mentioned in the job description?

Sample Answer 2: Prioritizing and handling multiple concurrent tasks with attention to detail is essential in a fast-paced environment, and I have a proven track record in this regard. To effectively manage multiple tasks, I start by creating a prioritized task list, taking into account deadlines and the importance of each task. I use project planning software, like Wrike or MS Project, to create timelines and allocate time for each task. During execution, I maintain a strong focus on the details, ensuring that each task is completed accurately and in accordance with the established quality standards. I also regularly review my task list to adjust priorities as needed and ensure that nothing falls through the cracks.

Question 3: Could you provide an example of a challenging situation where you had to collaborate with cross-functional teams to review and approve content? How did you handle it?

Sample Answer 3: Certainly. In my previous role, we were working on a complex promotional campaign that required input from various cross-functional teams, including marketing, medical, and regulatory. The challenge was ensuring that the campaign not only met regulatory requirements but also conveyed the scientific and medical information accurately.

To address this, I initiated regular cross-functional review meetings to align everyone’s expectations and goals. During these meetings, we discussed the campaign’s objectives, reviewed the content together, and addressed any concerns or questions. I encouraged open communication and collaboration among team members. When disagreements arose, I facilitated discussions to reach a consensus.

Ultimately, by fostering collaboration and ensuring everyone’s perspectives were considered, we successfully developed a campaign that met all regulatory and medical accuracy standards while effectively reaching our target audience.

Question 4: Can you describe your experience working with content and project management tools like Veeva Vault, Wrike, or MS Project, as mentioned in the job description?

Sample Answer 4: I have extensive experience working with content and project management tools, including Veeva Vault and Wrike. In my previous role, we used Veeva Vault for document management and workflow processes. I was responsible for uploading, reviewing, and approving content within the system. I also utilized Wrike and MS Project for project planning and task management. These tools helped me create project timelines, allocate resources, and track the progress of multiple projects simultaneously.

I believe that proficiency in these tools is crucial for ensuring efficiency and transparency in the review and approval process, and I am well-versed in their functionalities.

Question 5: The job description mentions the need for expertise in specific therapeutic areas. Can you provide an example of how your knowledge and experience in a particular therapeutic area contributed to the successful review and approval of medical materials?

Sample Answer 5: Certainly. In my previous role, I specialized in oncology, and my in-depth knowledge of this therapeutic area played a significant role in ensuring the accuracy and relevance of medical materials related to oncology products. For instance, when reviewing clinical data and publications for an oncology drug, I could identify potential gaps or inconsistencies in the data more effectively due to my familiarity with the subject matter.

Additionally, my expertise allowed me to collaborate more effectively with oncology-focused teams, providing valuable insights during review meetings and discussions. This expertise helped ensure that the content not only met Lilly’s quality standards but also addressed the specific needs and concerns of healthcare professionals and patients in the oncology field.

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