Overview
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. The Clinical Trial Registry and Transparency Associate will lead development and preparation of documents for public disclosures according to Lilly systems and processes, ensuring global transparency regulations and requirements are followed. The role will collaborate with cross-functional, multidisciplinary teams across multiple geographies and phases of drug development to ensure/coordinate the accurate and timely disclosure of clinical trial information.
Primary Responsibilities
* Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management
* Demonstrates expertise in the clinical transparency and disclosure environment, with a specific focus in one or more areas: clinical trial registration on clinicaltrials.gov; trial results posting on CT.gov, EUDRA.CT/EU CTIS; plain language summaries of study results; document redaction, including Health Canada and EMA Policy 70 transparency submissions.
* Effectively identify, collect and evaluate documents, data, and input from multiple sources, functions, and regions to plan and prepare transparency deliverables.
* Conduct effective project initiation/kickoff meeting to ensure product/study team alignment and understanding.
* Ensure information is presented in a clear, complete, accurate, and concise manner.
* Ensure that key data/information/redactions are consistent across related deliverables.
* Coordinate expert/scientific reviews, collate reviewer’s comments, adjust content of deliverable as required based on internal/external input, and prepare final version.
* Ensure and coordinate quality checks for accuracy.
* Influence or negotiate change of timelines and content with team members.
* As needed, may build and manage relationships with vendors/alliance partners.
* Project and Stakeholder management.
* Lead the content creation and/or redaction process and apply effective project management skills to ensure timely completion of high-quality transparency deliverables.
* Build/communicate credible project timelines.
* Anticipate and mitigate risks to delivery.
* Work with teams and stakeholders to ensure smooth and timely work delivery and escalate issues, as appropriate, to ensure project completion.
* Effectively communicate project status to stakeholders.
* Knowledge and Skills Development
* Maintain and enhance knowledge of transparency regulations and guidelines.
* Maintain expertise in personal information and company confidential information identification.
* Maintain knowledge/expertise in plain language/health literacy concepts, and creating content for a lay audience.
* Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).
* Exhibit flexibility in moving across therapeutic areas, phase of development and deliverable types as needed.
* Maintain and enhance transparency skills and 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 area of focus (trial registration, trial results, PLS, redaction).
* 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 tool/technology expertise.
Minimum Qualification Requirements
* Bachelor’s degree in a scientific, health, or communications related field or, bachelor’s degree in any field with at least two years of transparency.
* High-level end-user computer skills (Adobe, MS Office applications, Word, Excel, PowerPoint).
* Mastery of English language skills, written and spoken.
Other Information/Additional Preferences
* Experience with transparency processes (CT Registry, Redaction, Plain Language Summary), including knowledge of regulations, guidelines and standards
* Understanding of biostatistics and clinical study designs.
* Verbal reasoning, attention to detail, critical thinking, and analytical ability.
* Demonstrated project management and time management skills.
* Ability to deal with ambiguity and to plan, prioritize, and manage conflicting priorities.
* Experience working with multiple functional areas across medical, regulatory, and legal and multiple time zones.
Lilly is an equal opportunity employer. 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 at the Lilly careers site. 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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Seniorities and Employment
* Seniority level: Entry level
* Employment type: Full-time
* Job function: Research, Analyst, and Information Technology
* Industries: Pharmaceutical Manufacturing
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