
Associate, Global Scientific Communications
2 weeks ago
Overview
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.
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
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.
Purpose
The purpose of the Associate, GSC Document Delivery role
is to provide leadership, internal coordination and guidance as a member of the GSC Document Delivery Team in producing high quality, electronically compliant documents for regulatory submissions (e.g., FDA/EMA) and/or publication deliverables (manuscripts, posters/presentations), and other transparency needs.
This role will partner across Global Scientific Communications (GSC) and with key GSC partners to ensure documents are completed with high quality and meet all guidelines, Lilly policies, and any external requirements.
Primary Responsibilities
Ensure timely delivery of error-free, high-quality documents that meet international standards of written English.
Correct errors in grammar, style, formatting, and syntax; identify and fix flaws in logic and flow.
Follow style guides/templates provided by the team; follow best practice based on Lilly internal standards.
Verify data against source files, ensure accuracy and consistency of data and content within and between related documents.
Collaborate with global counterparts and track document metrics across groups as assigned.
Document finalization/publishing services: produce final eCTD-compliant PDFs of medical regulatory documents; review and format Word files to meet compliance requirements; render Word files into PDFs; review PDFs and edit as needed to ensure all submission requirements are met.
Document Development and Project Management: provide editorial and project management support for planning, editing, quality reviews and timely submission of regulatory documents (formatting, proofreading, rendering, bookmarking; literature searches; milestone tracking; copyright processing; data/reference verification).
Manage Datavision, including data stewardship/project management responsibilities.
Support encoding efforts across therapy areas, functions and regions by editing, adapting word counts per venue guidelines and completing other steps in the publication's procedure as required.
Conduct literature searches, obtain copyright transfers and authorship agreements; verify data and references for accuracy; create figures/diagrams; write cover letters to journal editors; coordinate translation/validation as needed; ensure all submission steps are executed.
Maintain a strong customer focus and accountability for achieving timelines; coach new specialists; coordinate with vendors if activities are outsourced.
Process and Technology
Maintain proficiency in applicable software, tools, processes, and workflows; use creativity to introduce new tools and processes to streamline team workflow; improve document processes by establishing uniform cross-organizational practices and suggesting enhancements to minimize redundancy between databases and tools.
Therapeutic & Disease State Knowledge
Participate in and understand goals of communication strategies across therapeutic areas; maintain a working knowledge of product and disease state information; develop therapeutic knowledge to review deliverables for accuracy and assist with focused literature reviews and higher-level edits; be familiar with trial design, rationale, and data.
Minimum Qualification Requirements
Bachelor's degree (preferably in a scientific or health-related field) with a minimum of 2–3 years' relevant experience; or an advanced degree.
Other Information/Additional Preferences
Specialized knowledge of editing and proofreading techniques; high level of attention to detail and superior English-language skills.
Proven ability to multi-task and work under tight timelines with a can-do attitude.
Excellent project management, organizational, business, and record management skills; excellent verbal and written communication; ability to negotiate solutions to complex technical challenges with cross-functional colleagues, external vendors, and customers.
Strong problem-solving skills regarding streamlining non-routine problems; highly proficient in tools used in document delivery and quality (Microsoft Office, Adobe Acrobat, Document Authoring/Approval tools, Data Repositories, GraphPad, Adobe Illustrator, iEnvision, and other relevant software).
Understanding of the drug development process; demonstrated ability to work independently and as part of a team; ability to marshal efforts of multiple contributors; experience updating procedures or work instructions; ability to partner across cultures; willing and flexible to take on other duties when needed; position/title/level may vary by site or location.
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 () 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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