We’re looking for people who are determined to make life better for people around the world.
Eli Lilly Cork, is made up of a talented diverse team of over 1,400 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Lilly 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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!!
PURPOSE OF THE JOB:
The purpose of the Medical Writing Manager role supporting Chorus is to work with cross- functional, multidisciplinary teams to facilitate external scientific publications (including and not limited to, abstracts, posters, manuscripts and presentations), and/or regulatory documents (including, but not limited to, protocols, clinical study reports, briefing documents, regulatory responses, and marketing authorization applications).
CORE JOB TASKS:
Document Preparation / Document Management: Role-based Training Plan (Medical Writer)
1. Plan, write, edit, review, and coordinate the publication of scientific data through peer- reviewed journals and forums and/or regulatory documents.
2. Facilitate trial development and product registration.
3. Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
4. Ensure final documents and supporting quality check documentation (with all signatures where appropriate) are placed in appropriate document management system.
5. Exhibit flexibility in moving across development and preparation of multiple document types.
6. Work with teams to ensure smooth and timely development of documents.
7. Influence or negotiate change of timelines and content with other team members.
8. Effectively collect and evaluate information from multiple sources
9. Manage and track workload and escalate resource capacity issues as needed.
2.External Service Provider Management: Role-based Training Plan (Medical Writer)
10. Build / manage relationships with vendors / alliance partners.
11. Provide oversight on individual deliverables, including timeline management, delivery of feedback and issue management.
3.Knowledge and Skills Development: Role-based Training Plan (Medical Writer)
12. Maintain and enhance therapeutic area knowledge including, disease state and compound for assigned project.
13. Exhibit flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc.
14. Maintain and enhance knowledge of regulatory guidelines and publication guidelines.
15. Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to lead the scientific data disclosure planning, clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.
4.Knowledge Sharing and Consultant Support: Role-based Training Plan (Medical Writer)
16. Provide informal coaching to others by sharing technical information, giving guidance, and answering questions.
17. Exhibit technical expertise in specific document development.
18. Network with others to identify and share best practices globally.
19. Contribute to process improvements, suggesting opportunities where appropriate.
20. Provide database and other tool (e.g., document management systems) expertise.
5.Customer Focus: Role-based Training Plan (Medical Writer)
21. Work with internal and external speakers to develop and prepare presentations.
22. Engage in activities supporting reward and recognition, teambuilding, and diversity.
23. Support cross-functional coaching, mentoring, and training
MINIMUM JOB REQUIREMENTS (e.g., educational background, work history, etc.):
24. Bachelor’s Degree.
25. At least 2-3 years’ experience in drug development.
26. Demonstrated mastery of written English with experience in medical, scientific or technical writing fields (at least 1 year); professional verbal skills in English.
27. Cognitive abilities including verbal reasoning, attention to detail, critical thinking, and analytical ability.
28. Demonstrated project management and time management skills.
29. Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
30. Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).
31. Ability to work well across cultures and time zones.
Other Information/Additional Preferences:
32. Graduate degree with formal research component or in life sciences.
33. Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise).
34. Experience in clinical trial process or regulatory activities.
35. Experience writing regulatory or clinical trial documents.
36. Publication experience.
37. Ability to work well independently and as part of a team.
38. A writing exercise is required as part of the candidate evaluation process. Additional writing samples may be requested.
39. Limited travel, up to approximately 10%.
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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