Associate, Global Scientific Communications (GSC), Document Delivery

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.

Associate, Global Scientific Communications (GSC), Document Delivery

Position title/level may vary by site or geographic location

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 Hub (DDH) in producing high quality, electronically compliant documents for regulatory submissions (eg, FDA/EMA) and/or publication deliverables (manuscripts, posters/presentations), and other visibility 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, 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 Expert

• 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 guideline 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 supervise key milestone timelines; editing documents for style/usage and content; obtaining and processing copyright transfer; verifying data and references for accuracy
• Handle systems of record including but not limited to DataVision, RIM or Planisware Book of Work, with 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 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 driven.
• Coordinate workload and work assignments with DDH Air Traffic Control direction both locally and globally

• Achieve timelines by managing activities efficiently and proactively; use 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 advancement

• Maintain proficiency in applicable software, tools, processes, and workflows
• Use creativity to introduce new tools, processes, and structure to accomplish broader organizational goals and meet standards while providing solutions to streamline team workflow
• Improve document processes by establishing uniform cross-organizational practices; suggest process or tool enhancements to improve effectiveness and minimize duplication between databases and other tools

Therapeutic & Disease State Management

• Participate in and understand the goals of communication strategies across therapeutic areas and/or organizational units.
• Maintain a solid understanding 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 techniques
• High level of attention to detail and superior English-language skills.
• Proven track record 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 skills
• Excellent 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, VeevaVault RIM, Planisware Book of Work (BoW) and/or other software / databases used in the pharmaceutical industry.
• Understanding of the drug development process
• Demonstrated 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 (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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$65,250 - $148,500

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly