Lead Medical Writer

**Your mission**:

- As a Lead Medical Writer

**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

**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 therapeutic 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, and verbal and written communication skills
- Ability to work effectively on cross-functional, geographically diverse teams, establishes 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 defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration.
- 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**:

- 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.