Career Opportunities

Career Opportunities

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.

We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.

Senior/Principal Medical Writer

Location: South San Francisco, CA or San Diego, CA or Boulder, CO or Stamford, CT

Reports To:

Director, Medical Writing

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Senior/Principal Medical Writer 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.

Roles and Responsibilities of the Position*
  • 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; may work with medical writing contractors on a program to ensure consistency in messaging across a program.
  • Participates in the development/update of departmental procedures and templates.
  • Other duties as needed.
Required Qualifications and Background
  • BS and at least 4 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 and significant participation in preparation of clinical documents for regulatory submissions (e.g., clinical protocols, 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.
Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility 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.

Loxo Oncology, Inc. 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.