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.

Regulatory Operations Manager

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

Reports To:

Executive Director, Global Regulatory Affairs

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.

This individual will assist our Regulatory authors with formatting of all Regulatory documents as well as prepare and execute quality control over all Regulatory documents for submission to external vendors. Acting as the liaison between LOXO and external publishing vendors, this individual will maintain the submission tracker as well as be responsible for importing all submissions into Documentum. Act as Regulatory Affairs Documentum specialist in compiling and maintaining computerized files in support of all documentation systems.

Roles and Responsibilities of the Position*

  • Perform overall technical and developmental editing of clinical, regulatory, and development document types, including, but not limited to, protocols, protocol amendments, clinical study reports, Investigator’s Brochures, Investigational Medicinal Product Dossiers, INDs and IND amendments, briefing books, patient narratives, abstracts, and manuscripts.
  • Experience with document organization of Regulatory and CMC documents.
  • Perform full editorial reviews on above mentioned document types, ensuring correct grammar, mechanics, usage, style, template adherence, etc., according to company style guide and accepted standards.
  • Manage timelines/workload of document QC activities.
  • Perform document control quality reviews on controlled documents (e.g., SOPs, policies, forms) and department guidelines.
  • Review documents being logged within the quality document system to verify completeness, legibility, formatting, etc.
  • Assist with document control activities, as assigned, including electronic and paper logging, filing, and archiving of quality system documents; document change management; training documentation management, etc.
  • Assist with document logistics during regulatory inspections (e.g., retrieval, logging, review, notifications).
  • Other duties as assigned.

Required Qualifications and Background

  • BS/BA or higher in a relevant field.
  • At least 5 years of Regulatory Documentation/Publishing experience in an FDA (or equivalent) regulated industry.
  • Experience in quality control and/or quality assurance review of regulatory submissions / aggregate reports within the pharmaceutical/regulated industry is critical, including review of documents in an eCTD system.
  • Demonstrated analytical skills and extremely high attention to detail.
  • Demonstrated strength in oral/written communication and interpersonal skills; team player.
  • Demonstrated organizational skills. Experience with cloud based electronic document management systems (e.g., Veeva Vault, Documentum, NextDocs).

Physical Demands / Travel

The average travel for this position is 10-15% with some variation based upon the demands of the business imperatives.

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

No specific work demands.

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.