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.
Position Summary:
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.
Responsibilities:
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.
Education/Experience Requirements:
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.
Additional Skills/Experience/Requirements:
The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork.
Strong scientific writing, editing, and communication skills, with exceptional attention to detail and commitment to quality.
Demonstrated experience contributing to development of document strategy, authoring clinical, regulatory, and scientific documents within the biotechnology or pharmaceutical industry.
Knowledge of FDA, EMA, ICH, and other applicable regulatory requirements and guidance related to clinical development and regulatory submissions.
Proficiency with Microsoft Office applications, Veeva platforms, and electronic document management systems.
Strong project management and organizational skills, with the ability to manage multiple priorities and deliver high-quality work within established timelines.
Ability to work independently while collaborating effectively with cross-functional teams and stakeholders at all levels of the organization.
Experience mentoring writers preferred by not required.
Excellent interpersonal, verbal, and written communication skills, with the ability to communicate complex scientific information to both technical and non-technical audiences.
Demonstrated ability to adapt to changing priorities, evolving project requirements, and a dynamic development environment.
Ability to travel up to 10% domestically and internationally.
All positions have an essential job function to be able to perform face-to-face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.
This position will operate as part of a team based mainly on Pacific Standard Time; availability within... For full info follow application link.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer
