Associate / Sr. Associate - Global Scientific Communications - CMC Regulatory
Eli Lilly
- Cork
- Permanent
- Full-time
- Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects that supports and implements the regulatory submission strategy developed by GRA- scientists.
- Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate and complete the CMC regulatory documents.
- Conduct effective document initiation via a kick-off 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 including module summaries. Ensure 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.
- Coordinate management review and approval and facilitate data integrity review.
- Exhibit flexibility in moving across development and preparation of multiple document types.
- Influence or negotiate change of timelines and content with other team members.
- As needed, build and manage relationships with vendors/alliance partners.
- Lead the writing process and apply effective project management skills to ensure timely completion of high-quality CMC 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
- Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).
- Maintain and enhance scientific communication skills to align with audience needs and technology/digital evolution.
- Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment.
- Maintain and enhance knowledge of CMC regulatory guidelines.
- Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.
- 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.
- Bachelor’s degree in a scientific, health, engineering, technology health related field, pharma sciences, chemistry, manufacturing, or other relevant sciences.
- Demonstrated experience in technical/CMC regulatory writing.
- Strong communication and interpersonal skills.
- Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)
- Graduate degree with formal research component in chemistry, analytical science, drug product/drug substance science, CMC research and development, manufacturing, quality, engineering, or other relevant sciences.
- Demonstrated mastery of verbal and written English skills in the medical, scientific, health outcomes, or technical writing fields.
- Experience writing regulatory, CMC regulatory, clinical trial documents and/or technical publications.
- Pharmaceutical industry experience in CMC technical drug development desirable.
- Prior Regulatory CMC experience or equivalent combination of technical and regulatory guidance knowledge is desirable.
- Experience in clinical development, clinical trial process or regulatory activities.
- Demonstrated attention to detail, project management and time management skills.
- Demonstrated effective collaboration and teamwork skills; able to adapt to diverse interpersonal styles.
- Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).