Associate Director, Medical & Regulatory Writing

📋 Description

• Serves as the assigned medical writer and subject matter expert in preparing clinical regulatory
• Execute clinical trials transparency and disclosures (CTD) book of work and provide vendor
• Collaborates with the cross-functional team comprised of regulatory affairs, clinical development
• Manages the document review process ensuring conflicting and/or ambiguous comments are clarified
• 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

🎯 Requirements

• Masters, advanced degree, or equivalent experience in Life Sciences or equivalent is required; PhD
• Minimum of 8-10 years of relevant industry experience as a regulatory/scientific medical
• Experience in the pharmaceutical, biotechnology, or CRO environment.
• Experience authoring clinical studies: protocols and clinical study reports, regulatory submissions
• Experience authoring and integrating medical writing projects, ideally including oncology clinical
• Ability to work effectively in a collaborative team environment where results are achieved.

🎁 Benefits

• Data-Driven Culture with robust regulatory writing for oncological and regulatory submissions.
• Commitment to respecting data privacy, in an equal-throughput, patient-focused environment.
• Kura Oncology is an EEO employer with E-Verify, employee benefits, competitive and diverse.
• Medical, dental, and 401(k) plans provided.
• Potential for relocation.
• Inclusive, diverse, and egalitarian environments in multiple roles.