Associate Director Medical Writing

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.

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

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)

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 function