Job title: Technical Writer- BRD
Company: Lilly
Job description: Responsibilities The Bioproduct Research & Development (BR&D) organization within Eli Lilly and Company supports the design, development, and commercialization of drug products for parenteral delivery that include biologics, oligonucleotides, pepti
Responsibilities The Bioproduct Research & Development (BR&D) organization within Eli Lilly and Company supports the design, development, and commercialization of drug products for parenteral delivery that include biologics, oligonucleotides, peptides and other chemical entities. This position is to partner with BRD scientists and engineers and other CMC team members, and/or other writers to execute and maintain scientific and submission documents. This includes supporting BRD in the production and review of scientific/technical documents, including technical protocols, SOPs, technical reports, regulatory submission documents, manuscripts for external publication, abstracts, posters, presentations, 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 multiple CMC projects, responsible for the timely completion/coordination of multiple technical reports and documents in close collaboration with the formulation or engineering lead. Independently writes and edits development, qualification, and regulatory submission documents in accordance with company and project priorities and timelines. These documents include, among others, technical reports, development history reports, components in the IND, BLA or NDA, external publications, and related documents. Supports other CMC functions by helping complete documentation on technical reports and IND/ BLA/NDA sections that involve inputs from analytical, DDCS and other teams. Performs data integrity review of the documents following local quality requirements and SOPs to ensure data accuracy and retrievability. Copies, edits, and proofreads 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. Ensures that people and their environment are safe and that company policies concerning safety are followed. Enhances 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 2 years of relevant experience in a pharmaceutical or biotech company or in an academic institution. 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 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.
Expected salary:
Location: Bangalore, Karnataka
Job date: Wed, 02 Feb 2022 23:03:51 GMT
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