Job title: Technical Writer – DDCS
Job description: Responsibilities The Delivery, Device and Connected Solutions (DDCS) organization within Eli Lilly and Company supports the design, development, and commercialization of drug products and pharmaceutical delivery systems including medical devices and
Responsibilities The Delivery, Device and Connected Solutions (DDCS) organization within Eli Lilly and Company supports the design, development, and commercialization of drug products and pharmaceutical delivery systems including medical devices and container closure systems. This position is to partner with DDCS engineers/scientists, statisticians, other team members, and/or other writers to develop scientific and submission documentations. Assist DDCS engineers and scientists in the creation and review of scientific/technical documents, including technical protocols and reports, interim/study reports, regulatory submission documents, manuscripts for external publications, literature search and review, abstracts, posters, presentations, data integrity review, and other items. Key Objectives/Deliverables: The Technical Writer will contribute to the development and launch of pharmaceutical products with the following responsibilities: As lead writer for a project or program, the technical writer will be responsible for the timely completion/coordination of all components of the project or program. As needed, coordinate 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, among others, biocompatibility test reports, method qualification reports, development history reports, packaging component and systems qualification reports, and packaging and device sections of BLAs, external publications, and related documents. Supports other medical device and packaging literature review and writing projects within the DDCS 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. Copyedit 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 identify 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. Ensure that people and their environment are safe and that company policies concerning safety are followed. Enhance Lilly’s professional image and competitive advantage through patents, presentations, publications, and professional activities. Basic Qualifications A minimum of a Bachelor’s degree, preferably in English language, scientific writing, or health-related science field, with a minimum of 5 years of relevant experience. Additional Skills/Preferences 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 reports, study protocols, and other documents. Understanding of ethical, compliance, legal, and regulatory guidelines and requirements related to scientific and regulatory submission documents. Ability to deliver oral presentations and write regulatory documents, summary reports, and SOPs in a clear, focused, and concise manner. Strong interpersonal skills and the ability to work productively in an interdisciplinary environment. Effective communication and collaboration skills with remote customers. Demonstrated effective verbal communication / presentation skills. Additional Information Limited travel may be required to Lilly sites globally. Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.
Location: Bangalore, Karnataka
Job date: Wed, 02 Feb 2022 23:26:36 GMT
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