better Customer Support Specialist - Clinical - Coag - Disetronic

Job ID: 00017446 Customer Support Specialist - Clinical - Coag - Disetronic Job facts Job function Customer & Product Support Location United States - Indiana Fishers Company/ Division Diagnostics Schedule Full-time Job type Standard Service How to apply Apply online Print

Assists the clinical science leader in all areas of project and study planning, evaluation, documentation including IND and annual report, clinical NDA preparation and protocol preparation. Is responsible for at least one study (in all aspects). Principal functional responsibilities: Assists in the timely medically and scientifically sound development of the clinical portions of a product development plan (PDP) the quality and timely preparation of all PDM documents submitted for approval GCP, Clinical Operating Guidelines and Standard Operating Procedures are followed within PDC and liaise...

Under the guidance of the projects Clinical Pharmacologist (CP), the CPS is responsible for overall planning, management, data evaluation and reporting of clinical pharmacology studies. The CPS leads protocol development and participates in study management as the primary clinical pharmacology representative. He/she provides clinical scientific input for final study reports and annual report documentation, and assists the CP in high-level IND and NDA documentation process. Alternatively, a CPS position could be held by an individual who provides expertise in an area of critical importance t...