Associate Director, Medical & Regulatory Writing

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology , you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology , we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

ESSENTIAL JOB FUNCTIONS:

The Associate Director, Medical & Regulatory Writing serves as a subject matter expert in the writing and production of clinical documents such as the writing of clinical protocols, protocol amendments, clinical study reports, Investigator’s Brochures, and briefing books. This role is also accountable for Clinical Trial Transparency & Disclosure (CTD) responsibilities and oversight of vendors carrying out such work. The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment. The qualified candidate will also have experience in oversight of external vendors. There needs to be a very strong understanding of document timelines as planning is critical.

- Serves as the assigned medical writer and subject matter expert in preparing clinical regulatory documents through all phases of clinical research.

- Execute clinical trials transparency and disclosures (CTD) book of work and provide vendor oversight

- Collaborates with the cross-functional team comprised of regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, etc. to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents.

- Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.

- Works closely with the study team to reach consensus on timelines for deliverables.

- Completes documents according to agreed-upon timelines for deliverables and follows up with the study team as needed to meet timeline commitments.

- Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.

- Support the development, improvement and maintenance of regulatory and scientific writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.

- Represent medical writing in cross-functional team meetings.

- Collaborate with department heads and staff members of cross-functional groups, including clinical development, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs as necessary to deliver documents with high quality on time.

- Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.

- Support the development, improvement and maintenance of medical writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.

- Lead the development of overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessary

- Lead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, websites, databases, and documents

- Ensure lean writing practices for