Our client is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.
You have an opportunity to experience living in one of the best places in Europe - Switzerland. This is an exciting chance to gain irreplaceable experience, both professionally and personally.
The company is now looking for a Regulatory Medical Writer on a 9-month fixed term contract basis for maternity cover, you can start as soon as 1st of July.
This position is responsible for the development of high-quality 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 a 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
• 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
• University degree in life sciences or other relevant scientific discipline required. An 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
To qualify Swiss work permit or EU passport is required.
If you are interested, I will be more than happy to arrange a call and tell you all the details about this position and more.
You can reach me by phone or by email: +44 207 940 2100 (ext.3508) or firstname.lastname@example.org
* 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 med