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Regulatory Writer

Latest job opening in Eli Lilly | Regulatory Writer | Freshers job 2024

Regulatory Writer

Eli Lilly (BENGALURU, KARNATAKA, India )

Job Description

Latest job opening in Eli Lilly for Regulatory Writer.Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration. Conduct effective document initiation meeting to ensure authoring team alignment and understanding

The purpose of the Scientific Communications Associate – Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications).

Skills set Required for this Job :
  • Graduate degree with formal research component or in life sciences.
  • Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields.
  • Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise).
  • Experience writing regulatory, clinical trial documents and/or publications
  • Experience in clinical development, clinical trial process or regulatory activities.
  • Demonstrated project management and time management skills.
  • Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).
  • Bachelor’s degree in a scientific, health, communications, technology health related field.
  • Demonstrated experience in technical/ regulatory scientific writing.
  • Strong communication and interpersonal skills.
  • Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)
Job Responsibilities
  • Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.
  • Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.
  • Conduct effective document initiation meeting to ensure authoring team alignment and understanding.
  • Build scientific-based rationale that support the purpose of more complex and/or strategic documents.
  • Ensure data are presented in a clear, complete, accurate, and concise manner.
  • Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.
  • Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
  • Ensure and coordinate quality checks for accuracy.
  • Exhibit flexibility in moving across development and preparation of multiple document types.
  • Influence or negotiate change of timelines and content with other team members.
  • Work with internal and external experts to develop and prepare presentations.
  • As needed, may build and manage relationships with vendors/alliance partners.

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Application Deadline

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Additional Information

Job Location(s)

BENGALURU, KARNATAKA, India

Experience

Freshers / Experience

Salary

Best in industry

Job Type/Timing

Job Type: In Office Job Timing: Full Time

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