Eli Lilly and Company Hiring Regulatory Medical Writer

Eli Lilly and Company Hiring Regulatory Medical Writer

22 June, 2022

Eli Lilly and Company Hiring Regulatory Medical Writer

Job Description:

Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management

  • 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.

Project and Stakeholder management

  • Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents.
  • Build/communicate credible writing project timelines.
  • Anticipate and mitigate risks to delivery.
  • Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.
  • Effectively communicate project status to stakeholders.

Knowledge and Skills Development

  • Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).
  • Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment.
  • Maintain and enhance knowledge of regulatory guidelines and publication guidelines.
  • Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.
  • Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms.

Knowledge Sharing

  • Provide coaching to others by sharing technical information, giving guidance, answering questions.
  • Recognized for technical expertise in specific document development.
  • Network with others (including other functions and regions) to identify and share best practices.
  • Contribute to process improvements, suggesting opportunities where appropriate.
  • Provide database and other tool (e.g., document management systems) expertise.

Minimum Qualification Requirements

  • 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)

Other Information/Additional Preferences

  • 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).

Apply HERE

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