Description
I have requirement for a Principal Regulatory Medical writer (clinical and regulatory documents) for a major pharma in New Jersey. This is for a senior writer with around 10 years experience in a major pharma, with submissions experience.Experience Required
-Ability to hit the ground running in a wide variety clinical and regulatory docs, including:
- Investigator Brochures,
- Clinical Study Reports
- Integrated Summaries of Efficacy and Safety
- Clinical Summaries of Efficacy and Safety
- Pediatric Investigation Plan,
-Understanding of EMA, FDA and ICH guidelines
-Act as a medical writing lead, work independently or give direction to other writers
- Intergral to a submission process (ectd)
-Previous leadership or supervisory/mentoring experience (3-5 years)
-BS/BA degree in science
This is a 12 month rolling contract opportunity. If you are interested please attach an up to date CV and I will be in touch.