Medical Writer
Vor 5 Tagen
**About Idorsia Pharmaceuticals Ltd**
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,200 highly qualified specialists dedicated to realizing our ambitious targets.
**Responsibilities**:
- Serve on early development and life cycle teams as the preclinical medical writer to support development of individual compounds in a wide range of therapeutic areas
- Compile, edit, and manage review of preclinical sections of regulatory documents (IBs, briefing books, IND/NDA/MAA Modules 2.4, 2.6, 4) authored by cross-functional teams
- Perform quality control checks of the above documents to ensure accuracy, completeness, and scientific robustness of content, consistency of reported preclinical data, compliance with Idorsia style guides etc.
- Review, edit, and archive nonclinical study reports using an electronic document system (Veeva Vault)
- Support preparation and submission of preclinical publications
- PhD degree in life sciences
- Excellent written and spoken English including scientific terminology
- At least 2-3 years of experience as medical writer
- Ability to make own judgement about robustness of a scientific statement and whether it is supported by the available data
- Ability to effectively communicate with other members of a cross-functional team (e.g., preclinical and clinical researchers, regulatory specialists, project managers) on a daily basis
- Ability to prioritize tasks while working on multiple projects in parallel
- Ability to provide high-quality medical writing support with mínimal supervision
- Sharp eye for detail
- Advanced knowledge of Microsoft Word (styles, cross-links, bookmarks, tracked changes, etc.)
The position is office based with home office flexibility for Swiss residents.
**What Idorsia offers**
- Exciting opportunities for development and professional growth within our dynamic organization
- A collaborative and solution-oriented environment where you can make a difference
- An innovative and open culture in a truly multicultural environment
- A competitive salary and generous social benefits
**Work Location**:Allschwil - Basel Area
**Country**:Switzerland
**Business Area**:Preclinical Development - Project Management
**Schedule**: Fulltime
**Job Type**:Permanent
**Job ID**:3830
**_At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success._**
**_We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees._
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