The Delivery and Device Research and Development Division within the Lilly Research Laboratories is an integrated drug development and delivery organization which spans the life cycle from candidate selection to submission and post-approval for both small molecules and biologics (peptides and antibodies).This position is to partner with DDRD engineers/scientists, statisticians, other team members, and/or other writers to develop scientific documentations. Assist DDRD engineers and scientists in the production and review of scientific/technical documents, including technical protocols, interim/study reports, regulatory submission documents, manuscripts for external publications, abstracts, posters, presentations, and other items.
- As lead writer for a project or program, 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, 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 DDRD 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 retrieveability.
- 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.
Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples’ quality of life for more than 140 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees – in competitive salaries, training and development, and health.The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.
- A minimum of a Bachelor’s degree, preferably in English language, scientific writing, or health-related science field, with a minimum of 2 years of relevant experience.
Know your eligibility here to apply for the job.
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