Lilly Associate-Design Hub Medical Writing in Indianapolis, Indiana
The Design Hub Scientific Communications Associate is responsible for working with the Foundations Design Team to deliver knowledge, expertise, standard templates, and technology to produce hub deliverables. This role will partner with design teams to generate hub creation of the protocols, amendments, IBs, master trial consents, and other documents. In addition, the associate will collaborate with hub and team resources to create functional requirements currently contained in various trial-level deliverables. This includes strategies to the asset teams to ensure a smooth transition to execution.
Document Preparation, Development and Finalization/Document Management
Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions.
Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review and coordinate regulatory documents supporting clinical development/product registration.
Conduct effective document initiation to ensure authoring team alignment and understanding.
Assist in building persuasive and scientific-based arguments 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, strategically aligned scientific narrative, elements from internal guidance and resource documents are included appropriately in all documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.
Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
Exhibit flexibility in moving across development and preparation of multiple document types.
Work with teams to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.
Influence or negotiate change of timelines and content with other team members.
External Service Provider Management
Build and manage relationships with vendors/alliance partners.
Provide oversight on individual deliverables, including timeline management, delivery of feedback and issue management.
May participate in in-licensing and co-development activities, including ensuring the quality of data in documents.
Support the implementation of the outsourcing strategy by effectively partnering with staff, Design Hub Foundations Integrated Delivery management team, internal outsourcing team, technical lead consultants, and vendor staff.
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 compounds, depending on project assignment.
Maintain and enhance knowledge of regulatory guidelines.
Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in the scientific data disclosure planning, clinical planning, submission strategy planning, and customer regulatory responses and maintain awareness of literature updates and reviews
Provide coaching to others by sharing technical information, giving guidance, answering questions.
Recognized for technical expertise in specific document development.
Network with others (including other functions and regions) to identify and share best practices.
Contribute to process improvements, suggesting opportunities where appropriate.
Provide database and other tool (e.g., document management systems) expertise.
A writing exercise is required as part of the candidate evaluation process. Additional writing samples may be requested.
Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields
Experience writing regulatory, clinical trial documents and/or publications
Graduate degree with formal research component or in life sciences.
Experience in clinical development, clinical trial process or regulatory activities
Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise).
Demonstrated project management and time management skills.
Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).
Lilly is an EEO/Affirmative Action Employer and 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
Associate Medical Writer - Design Hub
Bachelor’s degree in scientific, health, communications, or technology related field or a Bachelor’s degree in any field with at least two years of clinical development experience
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
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 39,000 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.
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