Associate / Sr. Associate - Global Scientific Communications - CMC Regulatory
6 months ago
We’re looking for people who are determined to make life better for people around the world.
Are you interested in Chemistry, Manufacturing and Controls (CMC) drug development, technical writing, and leading cross functional teams?
The purpose of the Scientific Communications Associate – CMC Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of CMC regulatory documents intended for regulatory audiences.
Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.
At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.
Primary Responsibilities : This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Responsibilities:
1.Content Strategy: 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 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.2.Project and Stakeholder management
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
3.Knowledge and Skills Development
4. 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, 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)Additional Skills/Preferences:
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).Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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