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

Your mission

As a Lead Medical Writer, you will plan, author, and 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, and 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 the UK, Germany, or France (remote position), will report to the Vice President of 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 and therapeutic areas.

Your profile

• Bachelor’s degree or equivalent. Advanced degree in life sciences or related field, or equivalent experience preferred.
• Working or academic knowledge in anti-infectives/antiviral therapeutics is preferable.
• Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
• Demonstrated ability to produce clear, high-quality scientific writing in the English language.
• Ability to independently analyze and synthesize data and non-clinical and clinical concepts from a broad range of disciplines.
• Project management skills: consistently achieves multiple tasks and goals on time.
• Strong interpersonal, verbal, and written communication skills.
• Ability to work effectively on cross-functional, geographically diverse teams, establishing strong collaborative relationships.
• Thinks through problems clearly and logically.
• Adapts to changing conditions.

Why us?

• Unique corporate culture: Scientific excellence, a collaborative working environment, and the passion to improve the lives of patients define our work.
• Development: We encourage people to grow and strongly support individual development and learning opportunities.
• Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life.
• Benefits: Competitive comprehensive benefit plan.

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.