Medical Writer
- Recruiter
- CK Clinical
- Location
- Crawley
- Salary
- Competitive
- Posted
- 27 Jul 2021
- Closes
- 04 Aug 2021
- Sectors
- Health, Nursing & Social Care
- Contract Type
- Permanent
- Hours
- Full Time
CK Clinical are recruiting for a Medical Writer to join a well-established, global CRO, based from their site in West Sussex.
*Responsibilities:*
* Investigational Medicinal Product Dossiers (IMPDs)
* Clinical Trial Applications and amendments
* Clinical study protocols and protocol amendments
* Investigator brochures and updates
* Interim and final clinical study reports
* Development Safety Update Reports
* Patient Informed Consent Forms
* Scientific Advice Briefing documents
* Provide guidance and support to other in-house units in preparation or review of manuals, training guidelines and similar documents.
*Your Background:*
* Minimum of a BA/BS in Science. Advanced degree in a health-related science is desirable.
* A PhD or MSc in Biology or health-related science is desirable and proven experience in pharmaceutical medical writing is preferred.
* Familiarity with industry principles of drug safety, EU and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology
* Knowledge of ICH guidelines, drug regulation guidance, drug development processes
* Excellent written and verbal skills
*Apply:*
Entitlement to work in the UK is essential. For more information or to apply for this Medical Writer position, please contact Aliza Qureshi on or email . Please quote reference 51213 in all correspondence.
*Responsibilities:*
* Investigational Medicinal Product Dossiers (IMPDs)
* Clinical Trial Applications and amendments
* Clinical study protocols and protocol amendments
* Investigator brochures and updates
* Interim and final clinical study reports
* Development Safety Update Reports
* Patient Informed Consent Forms
* Scientific Advice Briefing documents
* Provide guidance and support to other in-house units in preparation or review of manuals, training guidelines and similar documents.
*Your Background:*
* Minimum of a BA/BS in Science. Advanced degree in a health-related science is desirable.
* A PhD or MSc in Biology or health-related science is desirable and proven experience in pharmaceutical medical writing is preferred.
* Familiarity with industry principles of drug safety, EU and international regulatory guidelines, drug development, biostatistics, pharmacology, clinical trial methodology and oncology
* Knowledge of ICH guidelines, drug regulation guidance, drug development processes
* Excellent written and verbal skills
*Apply:*
Entitlement to work in the UK is essential. For more information or to apply for this Medical Writer position, please contact Aliza Qureshi on or email . Please quote reference 51213 in all correspondence.