Hybrid Expert Specialist - Global Scientific Communications - Regulatory en Lilly

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 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 purpose of the Specialist, GSC Regulatory role is to support the delivery of GSC regulatory documents with all aspects of regulatory document planning, tracking, and compliance.  The Regulatory Specialist is responsible for assisting the team, in managing and maintaining the regulatory document planning and tracking tools.  They are also responsible for generating status, productivity, and other metrics reports for the regulatory document team.  Conducting quality reviews required for regulatory documents prior to finalization is also part of the responsibilities.  The Specialist supports the team by ensuring that regulatory documents are compliant with guidelines, Lilly policies, and any external requirements.

The Specialist will independently interact with teams in other functional areas and with external vendors as needed.

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.

Regulatory Document Delivery Process Expert

• Serve as a regulatory document delivery process expert; understand required workflow, tools, and processes.
• Maintain proficiency in applicable software and current tools.
• Keep regulatory document tools updated in a timely fashion, consistently and accurately, which involves creating new records, tracking projects as they progress through the systems, closing projects, and remediating records as needed. 
• Execute metrics reports using data extracted from software tools to drill down into operational aspects of a project.
• Audit regulatory workflow tools for consistency and optimal use.
• Use creativity to introduce new tools, processes, and structure to accomplish broader organizational goals and meet standards while providing solutions to global workflow.
• Serve as a resource for others associated with document process/products and be an expert on specifications, timelines, and process. Help develop training materials and related change management tools to stakeholders in optimizing use of tools.
• Improve document processes by establishing uniform cross-organizational practices; suggest process or tool enhancements to improve effectiveness and minimize redundancy between databases and other tools.
• Function as a SME and participate in updates to relevant documents and guides.

Document Development / Project Management

• Manage the document development process for regulatory documents.
• 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; and acting as a single point of contact for regulatory operations and publishing groups.
• Retrieve electronic source data directly from a variety of computer systems and locations.
• Support the creation of presentation-quality materials using information provided by team personnel.
• Own the processes for document submission along with all associated final steps in the submission of regulatory documents.
• Monitor the progress of projects with the goal to maintain timelines and resources for document creation and review. Produce / interpret regulatory document book of work reports.
• Understand and apply the Lexicon to work products.
• Collaborate with necessary personnel/functional areas including regulatory operations and publishing groups to identify and resolve potential issues (e.g., project timelines, conflicting resources).
• Proactively and systematically follow up with GSC Regulatory management and other department managers to resolve outstanding issues. Independently initiate actions/meetings as appropriate.
• Responsible for the end-to-end creation of materials using various software programs and internal systems.
• Coach new Specialists or others requiring development in core areas.
• Track document metrics across groups as assigned.

Therapeutic Area Expertise

• Participate in and understand the goals of the 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.

Manage Internal/External Relationships

• Maintain strong customer focus.
• Serve as a single point of contact for or external customers regarding document preparation.
• Project manage outsourced deliverables, including: coordinate and manage timelines with outsourcing vendors; provide scientific literature and data to vendor as needed, coordinate with internal business partners to determine content outlines; coordinate reference and data validation; and ensure vendors follow appropriate Lilly policy and procedures related to document development.

Minimum Qualification Requirements:

• 1 year of clinical research or pharmaceutical industry experience.
• 1 year experience in word processing, tables and graphics formatting and creation, spreadsheet and database management, presentation creation, and template management.
• 1 year editing experience with demonstrated command of English grammar and sentence structure and specialized knowledge of editing & proofreading techniques.

Other Information/Additional Preferences:

• Associate’s or Bachelor’s degree.
• Knowledge of regulatory documents (ie, study reports, safety updates, regulatory responses, briefing documents, submission dossiers), document control (ie, Documentum, Leo) and workflow (ie, Datavision) systems.
• Excellent written and verbal communication skills.
• Experience with medical/scientific publication databases/resources, including library retrieval.
• Creative and flexible problem-solving skills.
• Ability to communicate and negotiate solutions to complex technical challenges with cross-functional colleagues, external vendors, and customers.
• Excellent organizational, business, and record management skills.
• Demonstrated ability to work independently or as part of a team.
• Demonstrated project management and time management skills
• Understanding of the drug development process and IND and NDA purpose/structure.
• Experience in working with medical professionals.
• Ability to assertively marshal the efforts of multiple contributors to projects.
• Proven ability to assemble, share and apply key learnings across multiple projects.
• Ability to work across cultures.
• Demonstrated knowledge of medical and statistical terminology; willingness to expend effort in acquiring scientific knowledge and understand strategic issues.
• Familiarity with publications documents and process.
• Good collaboration skills, such as facilitating meetings and fostering an atmosphere of teamwork.
• Detail oriented.
• Travel:  Limited; less than 10%

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 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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