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.
Post : Scientific Writer
Key Objectives/Deliverables:
- 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.
Candidate Profile
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.
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:
Location: Karnataka
Education: Bachelor’s degree
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Scientific Writer
Job Code: 39267BR
End Date: 05-Jun-2018
See All B.Pharm Alerts B.Sc Alerts Bangalore Alerts
See All Other Jobs in our Database
.png)
