Associate Director/Director of Medical Writing

Job Description

About Us

Kali Therapeutics embodies transformation and renewal, inspired by the Hindu goddess Kali, symbolizing power and rebirth. Focused on groundbreaking advancements in immunotherapy, Kali Therapeutics specializes in T-cell engagers and other innovative therapies that address high unmet medical needs.

About The Role:

As the Associate Director/Director Medical Writer, you will be responsible for the preparation of high-quality regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator’s brochures, and informed consent forms. You will also be responsible for more complex writing assignments and will serve as subject matter expert within the department. You may also be responsible for planning, managing, and preparing internal and external communications of key scientific and clinical data, including abstracts, poster and oral presentations, manuscripts, congress materials, and educational/training materials.

What You’ll Do:

• Serve as medical writing lead on complex writing assignments. Working closely with in-function and cross-functional teams on document strategies. Implement all activities related to the preparation of writing projects.
• Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Write, edit, and finalize CSRs, IND, pre-IND briefing books, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents.
• Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents.
• Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients.
• Work collaboratively with cross-functional groups and vendors to gather source data, and prepare and finalize regulatory documents.
• Lead project team meetings and document review meetings.
• Provide direction and solutions to cross-functional teams on expectations for document content.
• Perform QC of clinical and nonclinical documents.
• Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines.
• Perform other duties as assigned.

What You’ll Bring:

• A bachelor’s degree in science-related fields with 7+ years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D experience is required; Or
• A master’s degree in science-related fields with 5 + years of relevant industry experience in medical writing in large pharma or small biotech industry.
• Experience in IND, BLA or NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions is required.
• Strong scientific background in immunology, oncology, autoimmunity or related field
• Proficient knowledge of AMA writing guidelines.
• Excellent verbal and written communication skills in English.
• Extensive knowledge of FDA, NMPA, and ICH guidelines.
• Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
• Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
• Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously.
• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
• Ability to work collaboratively in a dynamic environment.
• Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates.

Kali is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. At Kali we engage in equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. We take care of our employees with a competitive benefits package that provides medical, dental, and vision coverage for employees and their dependents, as well as 401(k) plans.