CK Clinical are recruiting for a Senior/Principal Medical Writer to join a very successful, global consulting company. The role can be office based of full home based.
Senior/Principal Medical Writer Role:
- 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.
- 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.
For more information or to apply for this Senior/Principal Medical Writerposition, please contact CK Group, quoting job ref 50326.
It is essential that applicants hold entitlement to work in the country where the services will be delivered.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Stephanie Maccioni
- Phone: 01438 743047
- Reference: 50326
Website: CK Group
- Posted: 23rd April 2021
- Expires: 21st May 2021