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 will develop Idorsia into one of Europes leading biopharmaceutical company, 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 600 highly qualified specialists dedicated to realizing our ambitious targets.
We are looking for an enthusiastic and motivated Senior Medical Writerto join our Medical Writing Team within the Drug Regulatory Affairs Department.
This position is responsible for the development of clinical documents for submissions to regulatory authorities globally and works directly with multidisciplinary project teams. Job Responsibilities include :
- Write and/or review clinical regulatory documents such as clinical study reports and NDA/MAA submission documents
- Act as lead medical writer for submission documents and contribute scientifically and strategically at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing
- Contribute to the planning of data analyses and presentation for clinical study reports and submission documents; review statistical analysis plans and related documents
- Act as subject matter expert for regulatory requirements within clinical study and submission teams to ensure compliance of documentation to internal company standards and external regulatory guidelines
- Effectively collaborate with cross-functional stakeholders, including Therapeutic Area, Clinical Pharmacology, Biostatistics, Drug Safety, Clinical Operations, Preclinical Research, and Drug Regulatory Affairs
- Work together with the in-house Editorial Group to produce high-quality final documents and ensure timely delivery
- Contribute, as needed, to process and technology improvement and/or cross-functional initiatives related to regulatory writing and documentation
- Lead/assist with the selection and management of external medical writing services
- Mentor/train less experienced writers
- University degree in life sciences or other relevant scientific discipline required. Advanced degree is desirable
- English mother tongue, or excellent spoken and written English
- 5+ years as a medical writer in the pharmaceutical industry across several therapeutic areas
- Well-developed and proven medical writing skills, combined with an ability to interpret and present complex scientific data from different disciplines in a clear, concise format
- Advanced knowledge of global regulatory environment, including key document requirements, reporting guidelines and approval processes
- The ability to work independently and as part of a team
- Strong ability to work under pressure, prioritize multiple deadlines and projects and meet challenging deadlines
- Excellent interpersonal and presentation skills
- The ability to develop and mentor more junior medical writers
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 benefits
Work Location: Allschwil- Basel Area
Business Area: Global Clinical Development - Drug Regulatory Affairs - Medical Writing
Job Type: Permanent
Job ID: 2326
If you are interested, please click on apply now.
Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.
Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.