Associate, Global Scientific Communications (GSC), Document Delivery

Eli Lilly

  • Cork
  • Permanent
  • Full-time
  • 1 day ago
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 (eg, FDA/EMA) and/or publication deliverables (manuscripts, posters/presentations), and other transparency needs, as well as to participate in producing such. 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, Eli Lilly policies, and any external requirements.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.Scientific Communications Document Delivery ExpertEnsure 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 using publishing software
  • Review and format Word files to ensure as many compliance requirements are in the source file as possible
  • Render the Word files into PDFs
  • Review the PDFs and edit them as needed to ensure that all submission requirements are met
Document Development and Project Management
  • Provide editorial and project management support for the planning, editing, quality reviews and timely submission of regulatory documents including, but not limited to: formatting, proofreading, rendering, bookmarking; conducting literature searches; working with the writing team to establish and track key milestone timelines; editing documents for style/usage and content; obtaining and processing copyright transfer; verifying data and references for accuracy
  • Manage Datavision, including data steward/project management responsibilities
  • Support encoring 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 and process copyright transfer and authorship agreements; verify data and references for accuracy; create figures and diagrams, write cover letters to journal editors and coordinate and/or conduct translation and/or validation, ensure all steps of the submission process are executed
General expectations
  • Maintain a strong customer focus
  • Accountable for achieving timelines by managing activities efficiently and proactively; utilize ability to understand and apply team communication strategies to work products
  • Coach new Specialists or others requiring development in core areas
  • Coordinate with vendors if any of the previously mentioned activities are outsourced
Process efficiency and technological advancementMaintain proficiency in applicable software, tools, processes, and workflowsUse creativity to introduce new tools, processes, and structure to accomplish broader organizational goals and meet standards while providing solutions to streamline team workflowImprove document processes by establishing uniform cross-organizational practices; suggest process or tool enhancements to improve effectiveness and minimize redundancy between databases and other toolsTherapeutic & Disease State ManagementParticipate in and understand the goals of communication strategies across therapeutic areas and/or organizational units.Maintain a working knowledge of product and disease state information.Continue to develop therapeutic knowledge so that he/she can review deliverables for accuracy, assign keywords, and execute and critique 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 techniquesHigh level of attention to detail and superior English-language skills.Proven ability to multi-task and work under tight timelines with urgency to meet deadlines with a can-do attitude.Excellent project management, organizational, business, and record management skillsExcellent communication skills, both verbal and written, with the ability to communicate and negotiate solutions to complex technical challenges with cross-functional colleagues, external vendors, and customers.Strong problem-solving skills regarding streamlining non-routine problems in relation to department procedures and processes.Highly proficient in tools typically used in document delivery and quality (including but not limited to) : Microsoft Office, Adobe Acrobat, Document Authoring/Approval tools, Data Repositories, GraphPad, Adobe Illustrator, iEnvision platform and/or other software / databases used in the pharmaceutical industry.Understanding of the drug development processDemonstrated ability to work independently and as part of a team.Ability to assertively marshal the efforts of multiple contributors to projects.Demonstrated experience in updating procedures or work instructions.Demonstrated ability to partner effectively across cultures.Willing and flexible to take on other duties when needed.Position and title and level may vary by site or geographic 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.#WeAreLillyUKandIreland

Eli Lilly