Lead Medical Writer* (Reporting to Vice President Regulatory Affairs)

at  AiCuris Antiinfective Cures AG

YOUR MISSION

As a Lead Medical Writer * you will plan, author, organize the review process of documents pertaining to clinical studies and regulatory interactions, including (but not limited to) critical sections of marketing applications, protocols, clinical study reports, briefing documents, responses to agency requests for information. In this role, you will need to apply critical thinking, scientific writing, data interpretation, and knowledge of regulatory content life-cycle. You will oversee and coordinate other external writers assisting on documents under your responsibility, ensuring strict adherence to business objectives, company standards, as well as the organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar. The Lead Medical Writer*, based in UK, Germany or France (remote position) will report to the Vice President Regulatory Affairs.

Responsibilities

• Preparation of regulatory documents for the purpose of NDA/MAA/IND submissions as well as briefing packages in accordance with regulatory requirements and according to agreed timelines
• Leading preparation of complex documentation together with other medical writers’ support, e.g., clinical Module 2 documents including ISS and ISE
• Plans content and creates timelines for the production and review/approval of documents ensuring alignment with overall project timelines
• Reviews documents for organization, clarity, scientific standards, and consistency of content, data, and messaging. Resolves issues with cross-functional contributors.
• Ensures that documents are published in collaboration with the external publishing team
• Is a key strategic participant in functional and cross functional teams
• Actively contributes to best practices and continuous improvement of initiatives and projects
• Maintains up-to-date knowledge of key regulatory, scientific, and medical topics relevant to drug development, therapeutic area

ABOUT US

AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS, marketed by our partner MSD, treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.

Passionate about our mission to develop anti-infective therapeutics for patients in need, a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other’s personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn.

• AiCuris is an employer that supports equal opportunities, diversity and inclusion. We welcome applications from people regardless of their national origin, skin color, religion, gender, age, marital status, disability, sexual orientation, gender identity or other legally protected characteristics.

• Preparation of regulatory documents for the purpose of NDA/MAA/IND submissions as well as briefing packages in accordance with regulatory requirements and according to agreed timelines
• Leading preparation of complex documentation together with other medical writers’ support, e.g., clinical Module 2 documents including ISS and ISE
• Plans content and creates timelines for the production and review/approval of documents ensuring alignment with overall project timelines
• Reviews documents for organization, clarity, scientific standards, and consistency of content, data, and messaging. Resolves issues with cross-functional contributors.
• Ensures that documents are published in collaboration with the external publishing team
• Is a key strategic participant in functional and cross functional teams
• Actively contributes to best practices and continuous improvement of initiatives and projects
• Maintains up-to-date knowledge of key regulatory, scientific, and medical topics relevant to drug development, therapeutic are