Medical Writer

**MISSION**

Write, edit, and update scientific and clinical related documents, with a focus in neuroscience and pursuing the highest level of technical accuracy.

**MAIN ATTRIBUTIONS AND RESPONSIBILITIES**
- Write and edit clinical development related documents such as clinical study protocols, informed consent forms, clinical study reports, patients’ narratives, integrated summary reports, statistical analysis plan and other clinical documents.
- Support project leaders with the publication plan for assets under development.
- Lead the process of critical review of Investigator’s Brochure and incorporate multiple data from different contributors into successive drafts.
- Reviews clinical relevant documents for appropriate content, and for grammar, format, and consistency.
- Support clinical publication plan by writing and/or reviewing abstracts and manuscripts and being accountable for managing the task until the final submission.
- Performs on-line clinical literature searches, as applicable.
- Interacts with different staff members in pre-clinical and clinical research, clinical operations, medical affairs, and regulatory affairs, as necessary to produce writing deliverables.
- Update the Medical Writing process and templates and ensure compliance with current regulatory guidelines, good clinical practice and SOPs.
- Guide the activity to comply with the Quality, Environment, Health and Safety Policies and Standards and Procedures.

**PREFERENTIAL REQUIREMENTS AND SKILLS**

**REQUIREMENTS**
- PhD or Bachelor’s degree in Life Sciences with relevant writing experience in scientific and/or medical documents, preferentially in neuroscience area.
- Extensive knowledge of English grammar, familiarity with American Medical Association (AMA) style guide, and knowledge of authorities’ guidelines and ICH-GCP regulations.
- Familiar with the structural and content requirements of clinical development related documents with knowledge of the principles of clinical research and ability to integrate clinical data
- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach


**PREFERRED SKILLS**
- Strong teamwork skills required to work with a cross-functional team
- Focus on detail assuring high-level of data accuracy
- Good organizational, prioritization and time management skills
- Highly proficient in standard computer software (MS Word, Excel, PowerPoint)
- Autonomy, Results oriented and Proactivity