We are on the lookout for a driven individual with a passion for the biotechnology industry. One of our clients is looking to add a strong Director of Regulatory Assurance to their team:<br><br>1) Develop/refine strategic formulation regulatory plans for global development programs including Master Files, Common Technical Documents and CMC sections<br>2) Represent at FDA and international governmental agencies to provide chemistry, manufacturing and control information for development programs and ...
A Manager provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study team, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan, programming specification or user requirements document using internal standards and guidelines. The incumbent provides guidance in implementing and ...
- Perform in-depth clinical review of study data
- Co-monitor investigational study sites and assist with the management of the CRO to verify that study is conducted in compliance with the protocol, regulations and company SOPs
- Assist with CRO and vendor management
- Assist in management of clinical trial activities to ensure compliance with the study
protocol and overall clinical study objectives
- Assist with tracking study progress and ...
Director, Medical Science, Summit NJ area SUMMARY The Director of Medical Science (MS) is responsible for providing input into the Global Project Teams in planning, designing, developing, executing and interpreting clinical studies, including but not limited to those carried out in North America (NA) the global development program. The responsibilities include, but are not limited to writing or reviewing study synopsis and protocols, medical monitoring of clinical studies, input into clinical ...
This is an exciting opportunity to joing a wonderful local $4B pharmaceutical company
This role will report to the Senior Director, Global Clinical Affairs
We are looking for someone senior level that can hit the ground running
On site role - in Bronx, NY or Parsippany, NJ
This position is responsible for the administration, execution and project management of multiple Phase 1-4 clinical trials
Global experience a plus
Prior experience working on multiple projects at the same time is a plus
Shared Services Operational Oversight
-The ideal candidate will be someone who has been running Shared Services (A/P, A/R, Payroll, Record-to-Report, Purchasing Operations, Travel & Entertainment, etc.) on the global or international level for at least 5 yrs (MUST).-
- Total direct/indirect reports: 35-40.
-Must have strong experience with metric such as KPI’s.
-Someone who has a proven record of finding efficiencies.
-Someone who has helped automate processes.
-Someone who has set up goals ...
A biotechnology company is actively seeking a Specialty Sales Representative to join their team in the Northeast. This is a full-time permanent position.
The company is seeking candidates with the following qualifications:
5 years sales or related healthcare experience (specialty sales is required)
Medical Device and Pharmaceutical sales experience is required
Vascular, Pulmonary or Oncology experience is highly desired
Injectable experience is a plus
Must have hospital sales experience
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