Regulatory Medical Writer
Jocelyn Blackham is recruiting for a Regulatory Medical Writer to join a growing company in the biopharmaceutical industry at their site based in Allschwil on a 9 month maternity contract basis.
The main purpose of the role will be to:
- 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
Further responsibilities will include:
- Acting 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
- Working together with the in-house Editorial Group to produce high-quality final documents and ensure timely delivery
In order to be considered for this role, you will be required to have the following qualifications, skillsand experience:
- University degree in life sciences or other relevant scientific discipline required. Advanced degree is desirable
- Previous experience working 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
- English mother tongue, or excellent spoken and written EnglishThis is an excellent opportunity to join an expanding company in the biopharmaceutical setting.
For more information or to apply for this position, please contact Jocelyn on 0041 (0) 800 106 106 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote reference 50764 in all correspondence.