At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 45,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’
wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
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.
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
- 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.
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 is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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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