Responsible for working collaboratively with the Lead Study Clinician, Clinical Operations.
Study Team Lead (COSTL), and other members of the Study Team (e.g. Alliance Partner/ CRO for Client Run Studies (PRS), Regulatory Affairs, Pharm Sci, Contracts and Outsourcing) to implement one or more clinical protocols, with focus on study start-up phase.
Key member of site feasibility team to identify, evaluate and select clinical sites and investigators. Will be responsibility for developing a site back ...
Our client, a large pharmaceutical company, is currently seeking a REGULATORY AFFAIRS SPECIALIST.Summary of purpose/major responsibilities:The Regulatory Affairs Specialist (RAS) will provide support for all product related regulatory activities such as creation, archiving and tracking of submissions to health authorities.Key AccountabilityRegulatory Submissions/Correspondence: Tracking and archiving- Work with Sanofi Pasteur and Contract Research Organization (CRO) colleagues to gather backlog of ...
Description The Regulatory Affairs Associate works effectively under Regulatory Strategic Development (RSD)
Work independently (under the limited supervision of a Regulatory Manager or above) to:
Organize documents and records to be included in regulatory submissions.
Provide upkeep of regulatory archives Assist in the preparation of paper and electronic submissions for regulatory authorities
Track due dates of routine submissions.
Prepare and submit routine regulatory documents to FDA, e.g. ...
The Associate Project Engineer will provide engineering assistance under appropriate direction in delivering projects to maintain business continuity in areas such as: 1) complying with regulations; 2) resolving product performance Issues; 3) sustaining supply chain continuity; and 4) improving profit margins.
Work related to products and components may include efforts in all technical phases of product and process development, including design and development planning, ...
Our client in Titusville, New Jersey is looking for a Project Physician.This is a long term consulting position.If interested, Please apply to this ad
Position: Project Physician
Location: Titusville, New Jersey
The Project Physician is a responsible member of a clinical team (Compound Development Team, CDT)) and reports to the CDT Leader. The PP will be dedicated to working with the team to manage the execution of a Phase 3 Efficacy and Safety Study of an anti ...
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