Scientific Writer, Medicines Innovation Hub, Lcci
2 weeks 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.
**Organization 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, USA. Our 39,000 employees worldwide 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.
The Medicines Innovation Hub (MIH) strives to discover, develop, and deliver creative medicines to patients through the development and commercialization of insulins, small molecules, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy systems. This organization is a multidisciplinary group that works collaboratively with therapeutic business units and manufacturing to deliver the incredibly exciting Lilly clinical portfolio to patients around the world.
The Lilly Capability Centre India (LCCI) located in Bengaluru India is a strategic investment made by Lilly to attract top talent from the vibrant academic and professional environment in India and deploy them to develop and enable critical capabilities for Lilly. The LCCI group in India houses a MIH team that works closely with the MIH team in Indianapolis in enabling the delivery of Lilly’s portfolio.
This position partners with engineers/scientists, statisticians, other team members, and/or other writers in the Medicines Innovation Hub (MIH) team to develop scientific documentations. This includes assisting BioProduct Research &Development (BR&D), Synthetic Molecule Design and Development (SMDD) and Delivery Design and Connected Solutions (DDCS) engineers and scientists in the production and review of scientific/technical documents, including technical protocols, interim/study reports, regulatory submission documents, and manuscripts for external publications, abstracts, posters, presentations, and other items.
**Key Responsibilities**:
- Responsible for the timely completion/coordination of all components of the project or program. As needed, coordinates the work of multiple writers contributing to the project or program, and reviews contributions for consistency.
- Independently writes and edits development, qualification, and regulatory submission documents in accordance with company and project priorities and timelines. These documents include, but are not limited to Drug substance and drug product technical reports, Analytical development reports, process characterization reports, development history reports, and development sections of BLAs, external publications, and related documents.
- Supports literature review and writing projects within the MIH organization, including writing, editing, and/or reviewing development strategies, and external benchmarking summaries.
- Perform data integrity review of the documents following local quality requirements and SOPs to ensure data accuracy and retrievability.
- Copy, edit, and proofread scientific documents, meeting materials, manuscripts for journal publication, abstracts, and other materials containing development data and information.
- Stays abreast of relevant new and current regulatory expectations, guidelines, and requirements for submission documents; and identifies opportunities for implementation.
- Ensures individual and departmental compliance with the laws, regulations, guidelines, procedures, and practices governing drug research and development, including the departmental and corporate standard operating, good manufacturing, and safety procedures.
- Enhance Lilly’s professional image and competitive advantage through patents, presentations, publications and professional activities..
**Educational Requirements**:
A minimum of a Bachelor’s degree, preferably in English language in a health-related science field or scientific
writing with a minimum of 2 years of relevant experience.
**Experience Requirements**:
- Two or more years of progressively increasing experience, either in medical writing, or regulatory affairs, within the pharmaceutical or medical device industry.
- Familiarity with Food and Drug Administration regulations, ICH guidelines, and other relevant regulations.
- Ability to independently identify and resolve inconsistencies between the reports, the references, and the data.
- Ability to interpret articles in scientific literature, laboratory repor
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