
Medical Affairs
1 week ago
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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
**Medical Affairs - Medical Writing**
Position title/level may vary by site or geographic location
**Purpose**:
Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.
As healthcare providers are deluged with data and are making choices in an increasingly complex and stressed health system, Lilly Medical Affairs is able to provide clear, credible answers that will set Lilly apart from its competitors. Medical Affairs’ 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. Medical Affairs (MA) brings deep medical expertise to healthcare providers and payers. MA focuses on answering their 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 the company 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. The MA content development team will be key in maintaining and creating content to support Medical Affairs activities such as:
- Slide Updates
- Internal Training Slides
- Manuscript Slides
- Data Slides
- Newsletters/ bulletin
- QR Compendium
- Affiliate Regional Slides
- HCP & patient education material
- Advisory board slides
- Competitive landscape slides
- Image sourcing, image redraws
- Lexicon
- MQAD (Medical Questions Analysis Document)
**Primary Responsibilities**:
This job description is intended 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 supervision regarding your actual job responsibilities and any related duties that may be required for the position.
**EMS (Executive Medical Summary)**
Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management
- Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.
- Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.
- Conduct effective document initiation meeting to ensure authoring team alignment and understanding.
- Build scientific-based rationale that support the purpose of more complex and/or strategic documents.
- Ensure data are presented in a clear, complete, accurate, and concise manner.
- Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.
- Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
- Ensure and coordinate quality checks for accuracy.
- Exhibit flexibility in moving across development and preparation of multiple document types.
- Influence or negotiate change of timelines and content with other team members.
- Work with internal and external experts to develop and prepare presentations.
- As needed, may build and manage relationships with vendors/alliance partners.
Project and Stakeholder management
- Build/communicate credible writing project timelines.
- Anticipate and mitigate risks to delivery
- Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.
- Effectively communicate project status to stakeholders
Knowledge and Skills Development
- Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).
- Exhibit flexibility in moving across document types, therapeutic areas, and compound
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