Associate Director, Medical Writing

Department: 107000 Regulatory

Location:

San Diego, USA
- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast‑paced environment and share in our mission - to identify, develop and deliver life‑changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

The Associate Director, Medical Writing is responsible for oversight and authoring (if needed) of regulatory submissions (Common Technical Documents [CTD]), as well as other regulatory, clinical, and safety documents, including but not limited to protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), and Periodic Safety Update Reports (PSURs). This position is responsible for contributing to the strategy of document development strategy, overall project management during the drafting, reviewing, and approval cycles of regulatory submissions and other documents, and as such may oversee other writers contributing to the submission.

This position will ensure documents that are compliant with company‑specific medical writing standards, are completed on‑time and on‑budget, and are ready for submission to global, regional, and local regulatory authorities. Additionally, this position will support projects across all phases of clinical development and post‑marketing life cycle management.

• Serve as the medical writing lead for regulatory submissions with oversight of contributing medical writers and responsibility for on‑time delivery of high‑quality submission documents.
• Provide strategic guidance to study teams as it relates to document creation/submission.
• Lead the overall strategy and execution of medical writing projects in support of therapeutic development programs.
• Collaborate with cross‑functional team members to ensure accurate and timely completion/delivery of high‑quality, scientifically justified documents.
• Responsible for the scientific accuracy and regulatory quality assurance of developed content and deliverables.
• Responsible for implementation of medical writing review processes, as needed.
• Communicate needed deliverables, writing processes, and timelines to team members.
• Contribute to the development and standardization of templates and related processes and assist in the development of templates, style guides, and SOPs for regulatory writing, as needed.
• Maintain expert knowledge of US and international regulations, requirements and guidance associated with clinical, regulatory, and safety document preparation and submissions.
• Lead and manage comment resolution meetings.
• Learn and apply knowledge of therapeutic area and product to scientific writing projects.
• Mentor junior writers as applicable.
• Develop, maintain, and drive document finalization timelines and coordination of document review.
• Lead/contribute to process improvement initiatives.

• Master's Degree in Life Science or related disciplines required;
  PhD or PharmD preferred. Equivalent combination of education and applicable job experience may be considered.
• Minimum 6 years of progressively responsible medical writing experience in a biopharmaceutical/industry environment or 8+ years at a Contract Research Organization (CRO) or related environment.

• The ideal candidate will embody Travere's…