Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated.
The Director of Medical Writing will be a key member of our Kyverna team responsible for leading and overseeing all medical writing activities across our portfolio of programs. This role, reporting to the Vice President of Global Regulatory Affairs, will require strategic thinking, strong leadership skills, and a deep understanding of medical writing best practices to ensure the preparation of high-quality clinical, nonclinical, and regulatory submission documents as well as scientific publications.
Responsibilities:
Leadership and Strategy:
Lead, mentor, and manage a team of medical writers, fostering a collaborative and high-performing culture.
Develop and execute the medical writing strategy to support clinical development programs, regulatory submissions, and publication efforts.
Collaborate with cross-functional teams to ensure alignment of medical writing activities with program objectives.
Regulatory Document Preparation:
Oversee the preparation, review, and editing of a wide range of regulatory documents, including clinical study protocols, investigator's brochures, clinical study reports, INDs, BLAs, and other submission documents.
Ensure that documents are prepared in compliance with regulatory guidelines and meet high scientific and ethical standards.
Participate in the planning and coordination of regulatory submissions, including eCTD formatting and assembly.
Publication Writing:
Lead the development of scientific and medical publications, including manuscripts, abstracts, posters, and presentations for conferences and peer-reviewed journals.
Collaborate with internal and external experts to gather data and insights for publication.
Ensure compliance with publication guidelines and ethical standards.
Management of External Medical Writers:
Coordinate and manage relationships with external medical writer contractors, including contract negotiation, project assignment, and quality control.
Provide guidance and direction to external writers to ensure the delivery of high-quality documents.
Collaborate with external writers to align their work with company standards and project timelines.
Quality and Compliance:
Implement and maintain best practices in medical writing to ensure consistency, quality, and compliance with industry standards and regulations.
Collaborate with Quality Assurance to support document audits and inspections.
Cross-Functional Collaboration:
Work closely with Clinical Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and other functional areas to gather data and information necessary for document preparation.
Serve as a subject matter expert and provide guidance on medical writing best practices to internal teams.
Documentation Management:
Develop and maintain standard operating procedures (SOPs) and templates for medical writing activities.
Support the design and implementation of document management tools (e.g. Veeva).
Ensure proper documentation and version control of all medical writing deliverables.
Qualifications:
Advanced degree in life sciences, pharmacy, or related field (PhD, PharmD, MD, or equivalent).
Minimum of 5-8+ years of experience in medical writing, including experience in a leadership or management role.
Strong knowledge of global regulatory requirements and guidelines for document preparation (ICH, FDA, EMA).
Proven experience in preparing and editing a wide range of regulatory documents for clinical trials and submissions.
Track record of successful scientific publication writing and peer-reviewed journal submissions.
Excellent leadership, communication, and interpersonal skills.
Ability to effectively manage and mentor a team of medical writers and external contractors.
Detail-oriented with strong organizational and project management abilities.
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