Principal Medical Writer – Remote – US
The Global Life Science Hub are working on an incredible Principal Medical Writing opportunity based anywhere Remote in US. This is an opportunity to join a blue-ocean biotech that has recently achieved a $200 Million IPO launch to help develop rare and unique cancer therapies in the T-Cell Therapy space.
The selected candidate will report directly to the Chief Medical Officer and will be responsible for being the key in building their medical writing department from early on. The Appointed candidate will have the privilege of working with some of the most well-known names in the T-Cell area.
- The purpose of the job of the Medical Writing is to prepare, write, and review scientific and regulatory documentation needed in support of research and development activities, including clinical trials and corresponding submissions to regulatory authorities and other writing and publication activities within the company
- The Medical Writer will assist the CMO during the strategic development for document authoring, ensuring high-quality, scientifically accurate documents, ensures consistency between related documents, and improves overall document quality.
- To accomplish this, the Medical Writer liaises primarily with the CMO, and in collaboration with internal and external stake holders. When appropriate,
- the Medical Writer will coordinate and support other writing and publications
- 5 years’ experience working within Regulatory writing
- A minimum of an undergraduate degree in a scientific discipline (B.A., B.Sc.), but a graduate degree (M.Sc., Ph.D., MD, MPH or Pharm.D.) is preferable.
- Experience writing Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, PSURs/DSURs, IMPDs/INDs
- Ability to thinking critically when structuring documents so that they present complex information in a logical manner and regulatory requirements
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com