Senior Specialist – Regulatory, GoLD in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Senior Specialist – Regulatory, GoLD in Indianapolis, Apply Lilly careers in Indianapolis Indiana.


Position : Senior Specialist – Regulatory, GoLD

Location : Indianapolis, Indiana

Job id: R-34099


Job Details

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 35,000 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.Purpose:The GRA-NA Global Labeling Department (GoLD) Senior Specialist is responsible for supporting core, US, and Canada labeling activities for Lilly drug, device, and combination device products. The specialist provides tactical leadership within their area of responsibility and works closely with co-workers to enable successful completion of tasks. The Specialist provides guidance regarding utilization of the document management system, governance committee interactions, Strutured Product Labeling (SPL) and Drug Listing, record retention requirements, periodic reporting, and labelling tracking activities. The Specialist works under minimal supervision, resolves most questions and problems independently, and utilizes judgment in selecting the appropriate guidelines and procedures that apply to assignments. The Specialist develops collegial, mutually productive relationships across customers and embraces transformation initiatives. Within the GoLD Team environment, the Specialist is responsible for the achievement of individual as well as team outcomes.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.1. Labelling Knowledgea. Demonstrate in-depth understanding of format and style requirements for labelling documents including regulations and trends.b. Perform product-related labelling tasks for drugs, drug/device combination products, and medical devices as necessary, including:Develop, update, maintain, and archive labelling documents utilizing appropriate tools and version control.Coordinate the review and approval process for labelling documents.Understand and execute instructions included in FDA and Health Canada communications, coordinating required activities with GoLD Associate and GRA-NA Clinical Regulatory Scientist as needed.Prepare required labelling documents for posting to the internal GoLD collaboration site and external sites as required.Plan, track, and record all steps of labelling submission and approval activities using the appropriate systems and tools.Execute the appropriate quality checks.Monitor eFiles to ensure all labelling-related documents and communications are appropriately archived and linked in GoLD’s tracking tools.c. Lead labelling contributions for periodic reporting (Annual Report, Periodic Safety Update Report, Periodic Benefit/Risk Evaluation Report, Development Safety Update Report), utilizing GoLD’s tracking tools and in collaboration with GRA-NA Clinical Regulatory Scientist.d. Manage document due dates to GRA-NA Central Regulatory Registrations (CRR) for labelling submissions. Enter submission dates in the GoLD Submission Tracker and initiate SAIL entries. Understand, communicate, and verify labelling submission dates, including the date documents are due to CRR.  Communicate changes in due dates, including the rationale for the change. Escalate timing issues as needed.e. Partner with GoLD Associate, GRA-NA Clinical Regulatory Scientist, and/or Device Regulatory to create and complete required cross-link spreadsheets for use in data integrity reviews and preparation of the annotated label for submission.f. Participate in Launch Team meetings as needed. Gather information  to understand and manage the order in which documents should be completed and supplied to enable a smooth launch process.2. Process and System Expertisea. May serve as an expert resource for the use of labeling-related templates and computer applications (for example, Microsoft Word, Leo, eCTD, TVT, eFiles, SAIL, May serve as process subject matter expert for US SPL, Canada Structured Product Monograph (SPM),eDrug Listing Process, and provide oversight of external vendor for SPL/SPM conversions.c. May assist with labelling-related governance [Global Product Labelling Committee (GPLC) and Global Labelling Council (GLC)]), including pre-read compilation, maintenance of collaboration sites, calendar management, capturing attendance, and appropriate record retention.d. May partner with Regulatory Management for Drug Listing to coordinate Establishment Fee and User Fee activities.e. May partner with the Regional Labeling Coordinator (RLC) to complete submission and production project tasks in BLUE.f. May perform duties of the Regulatory Internet Coordinator (RIC), responsible to post labelling to appropriate websites and maintain records of posted versions. Escalate posting issues promptly and appropriately.g. May maintain GRA GoLD-owned Collaboration Sites with a focus on keeping content current and recommending/implementing site changes.h. May be responsible for monitoring and reporting GoLD metrics. Evaluate and research trends for reporting to management.i. May manage the eArchive site (CAS) as the Data Steward.j. May lead GoLD Record Retention compliance.3. Advise and Influencea. Train, mentor, advise, and support less experienced personnel.b. Review or QC work of others.c. Share labelling knowledge within GoLD and key customers. Participate in internal working groups to make recommendations that may shape the regulatory labelling environment.d. Develop and communicate expertise in labelling regulations and trends related to format, style, packaging, labelling changes, and periodic reports.e. Utilize labelling expertise and organizational skills/project management skills to plan and execute a work strategy that enables teams to achieve on-time submissions.f. Positively impact regulatory cross-functional initiatives through active participation in process improvement projects, drafting/reviewing procedures, and problem solving.4. Work-Team Collaboration:a. Partner with team members to prioritize work and quickly address challenges and mitigate roadblocks, escalating as necessary.b. Be accountable and hold team members accountable to execute quality results in given area of responsibility.c. Value team and team member development.Minimum Qualification Requirements:High School Diploma or GED3-5 years of regulatory experienceCompletion of Post Offer Exam or Completion of Work Simulation (if applicable)Additional Preferences:Knowledge of FDA and Health Canada procedures and practices and awareness of evolving regulatory reform initiatives.Knowledge of Medical/Scientific terminology.Demonstrated skills in MS Office applications.Ability to learn about new software/technology.Demonstrated capability for contributing on complex projects.Proven flexibility to manage multiple tasks simultaneously.Demonstrated strong written, verbal and presentation communication.Demonstrated attention to detail.Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.Ability to prioritize projects.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).



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