Associate Director, Medical Writing

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).

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.
• 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.
• Able 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.