Description
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.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $140,800
Organization OverviewThe ADME, Toxicology, PK/PD, Laboratory for Experimental Medicine and Veterinary Resource (ATPLV) division within Lilly is accountable for ensuring the safety and efficacy of all drugs in the Lilly portfolio. As such, data / study documentation and regulatory reporting is a critical responsibility of the organization. The scientific communications representative (SCR), in conjunction with scientists, will provide support for ongoing projects to generate high quality on-time submission documents. The SCR will perform a myriad of Nonclinical data quality review activities, Nonclinical submission coordination for Marketing Applications, and provide document preparation, development, and management support across ATPLV. The SCR will support activities from both internal and external groups. Additionally, the SCR will drive process improvements by automating existing manual processes and lead in the development of new tools.
Are you ready to play a critical role in shaping nonclinical submissions that drive regulatory success and advance groundbreaking therapies? Join the Lilly team and bring your precision, collaboration, and scientific expertise to the forefront of innovation!
ResponsibilitiesThe individual will support Nonclinical Data Quality Review Activities, including:
- Perform the review for nonclinical regulatory documents from Toxicology, ADME, and Pharmacology
- Communicate and share scientific findings to authors/scientists and deliver nonclinical content with consistency, accuracy, and completeness
- Meet strict deadlines and work in a team environment for large assignments
Nonclinical Submission Coordination for Marketing Applications will be completed through the following activities:
- Partner with the Pharmaceutical Project Manager (PPM)/Submission and Approval Expert Network's (SAEN) representative to understand submission benchmarks
- Develop, implement, and maintain nonclinical timelines, aligning with the global organization submission timelines
- Lead and facilitate the discussion of nonclinical timelines and Table of Content (TOC)
- Coordinate submission document reviews, schedules, and host meetings to resolve team comments
- Work with Global Scientific Communications (GSC) to ensure ADME method validation reports are included in the submission packets
- Liaison with Japan Preclinical
General Document Preparation, Development, and Management will also be supported.
- Effectively collect and evaluate information from multiple sources
- Plan, write, and edit the nonclinical regulatory content and the IND documents, using the structured authoring style
- Effectively communicate deliverables and corresponding writing processes, project timelines, and benchmarks to respective project leaders to ensure prompt development of documents
- Ensure and coordinate quality checks for accuracy, check reviewer's comments, adjust content of document as required based on internal input, and prepare final version
- Proactively identify and champion nonclinical writing process improvements
- Drive shared findings of standard processes to peers and be a backup when needed
Finally, the individual would be required to aid in process improvements, including automation.
Basic RequirementBachelor's Degree with 2+ years of pharmaceutical technical writing experience in support of regulatory submissions
Additional Skills/Preferences- Proficiency in use of project management tools and techniques (e.g., Critical Chain, Veeva Vault, MS Project, etc.)
- Actively seek to deepen scientific and regulatory knowledge through constant learning and identifying gaps in expertise
- Proven project management and time management skills
- Ability to be flexible in adjusting quickly and effectively to frequent changes and altered priorities
- Cognitive abilities including verbal reasoning, attention to detail, critical thinking, and analytical ability.
- Demonstrated effective teamwork skills with ability to adapt to diverse interpersonal styles
- Prior technical writing experience within the biotech/pharmaceutical/clinical research organization (CRO)
- Proven ability to communicate with cross-functional teams (e.g. nonclinical, clinical, quality, regulatory, etc.)
Additional Information- A writing test or examples of writing proficiency may be requested
- Travel <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 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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
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.
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