Job Information
Lilly Associate Director Medical Writing in Remote, Indiana
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.
Organization Overview:
Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients. We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect. Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.
The Associate Director, Medical Writing will be responsible for the writing and editing of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory requirements of a clinical program.
Responsibilities:
In collaboration with clinical and regulatory, manages the authoring and document life cycle of clinical protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), electronic Common Technical Document (eCTD) summaries and other documents for submission to the Food and Drug Administration (FDA) or other regulatory agencies
Compiles, analyzes, and summarizes data from statistical tables and other sources, as needed
Liaises with cross-functional team members (e.g., clinical operations, clinical science, regulatory affairs, biostatistics, nonclinical) to ensure that information is accurately captured in documents
Coordinates document reviews; schedules and hosts meetings to resolve team comments
Acts as the medical writing representative for a program; supervises contract writers, as needed
Participates in departmental initiatives and process improvement
Other duties, as needed
Basic Requirements :
BS and at least 5 years of related experience (advanced degree (e.g., MS/PhD/PharmD) may compensate for years of experience)
Prior medical technical writing experience within the biotech/pharmaceutical/clinical research organization (CRO) realm
Experience as the lead writer on clinical documents for regulatory submissions (e.g., clinical protocols, IBs, CSRs, eCTD modules)
Additional Preferences:
Experience leading complex submissions (Investigational New Drug applications [INDs], New Drug Applications [NDAs], Biologic License Applications [BLAs])
Familiarity with therapeutic area of oncology desirable
Exceptional written and oral communication skills; strong attention to detail.
Ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
Knowledge of International Council for Harmonisation (ICH) guidelines for clinical and regulatory submission documents
Expert abilities in Microsoft Office
Ability to work in a fast-paced dynamic environment that involves frequent communication with project team
Excellent time management skills and ability to manage several projects simultaneously
Ability to communicate with cross-functional team members (e.g., clinical development, biometrics, regulatory affairs, quality assurance, manufacturing, nonclinical) and incorporate diverse feedback into a high-quality document
Additional Information:
The physical demands of this job are consistent with light office duties.
This position’s work environment is in an office.
Lilly (Eli Lilly and Company) currently anticipates that the base salary for this position could range from between $111,000-162,800 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo@Lilly (Eli Lilly and Company) 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo@Lilly (Eli Lilly and Company) reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Loxo@Lilly (Eli Lilly and Company) compensation practices and guidelines will apply regarding the details of any promotion or transfer of Loxo@Lilly (Eli Lilly and Company) employees.
*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.
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.
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