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Clinical Specialist - Contract Position
Pharmaceutical Clinical Associates, LLC
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Irving ,
TX
As a clinical specialist, you will be responsible for determining the needs of callers who are transferred through the provider queue and making appropriate and timely referrals to providers who request such on member’s behalf. You assist members transferred through the patient queue to obtain a listing of in-network providers and the set up initial certifications for routine outpatient therapy ... Read More
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Clinical Trials Lead
Pharmaceutical Clinical Associates, LLC
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Bala Cynwyd,
PA
Primary purpose and function of this position
Under the guidance of the Clinical Trials Manager or Clinical Trials Lead III, leads
clinical research trials in accordance with FDA regulations and ICH guidelines, good
clinical practices and company standard operating procedures and ensures
drug development project objectives are met.
Major duties and responsibilities that are critical and necessar ... Read More
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Assistant/Associate Director, Regulatory Affairs CMC
Pharmaceutical Clinical Associates, LLC
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Hoboken,
NJ
Provide strategic regulatory support to quality operations (QC/QA/Compliance), manufacturing, packaging, and component and product release sites - for Forest Laboratories, partners, and external Contract Manufacturing Organizations.
Design, develop, and manage a Change Control system for Regulatory CMC department. Serve as primary point of contact across all groups to evaluate the CMC related ch ... Read More
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Quality Improvement Manager
Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Defines metrics for continuous quality improvement actions, facilitates continuous improvement and the analysis of audit and inspection trends to drive the identification of risk areas, compliance issues, and opportunities for each of the functional lines in QA.
• Uses QA databases and input from QA colleagues, stakeholders and customers to monitor tren ... Read More
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Oncology Portfolio Quality Assurance Lead
Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
ESSENTIAL DUTIES AND RESPONSIBILITIES:
With assistance from Management, as needed, perform the following functions:
1. Provides day to day QA support to Company oncology portfolio.
2. Contributes to QA strategy and implementation to support goals of the portfolio or project team:
o Is accountable for the Quality Assurance strategy role out for the therapeutic area oncology.
o Works closely ... Read More
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Research Scientist I Bioanalytical Sciences Group
Pharmaceutical Clinical Associates, LLC
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Raritan ,
NJ
ESSENTIAL DUTIES AND RESPONSIILITIES:
Perform complex analyses related to protein/glycoprotein characterization. Develop new methods and optimize existing methodology to address analytical challenges related to current standards of “Well-Characterized Proteins”. Lead method development through validation and eventual transfer to QC. Apply acceptable cGMP practices during execution of all applic ... Read More
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OLAD Training Temp - Organizational Office and Learning
Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
GENERAL SUMMARY:
The OLAD Training Temp is responsible for assisting in maintaining a comprehensive, interactive, and compliant Training Program for company employees. This position will assist in the coordination of training programs and workshops organized by OLAD. Primary job functions include, but are not limited to, the following: provide administrative support to the OLAD department, as ... Read More
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Regulatory Affairs – Contract Assistant
Pharmaceutical Clinical Associates, LLC
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Union,
NJ
Responsibilities will include, but are not limited to, the following:
1. Create an electronic repository to organize and store information from hundreds of clinical sites across numerous clinical studies.
2. Follow Celgene SOPs
3. Verify accuracy of information on clinical site documentation
4. Adherence to required review timelines
5. Liaise with functional source areas (Celgene clinical opera ... Read More
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Process Associate
Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
Job Description -
A working knowledge of cell culture techniques, process and media optimization, bench scale bioreactor operations, scale-up and process transfer. Position requires the ability to develop production processes for proteins that are intended for human use. Familiarity of cGMPs in terms of practice and documentation is essential. The ability to interact and convey ideas in a way t ... Read More
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Sr. Manager/Manager, Regulatory Affairs
Pharmaceutical Clinical Associates, LLC
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Union ,
NJ
For all assigned products:
-Represent Regulatory Affairs as a member of Forest Project Teams
-Provide regulatory strategy to teams and management towards the filing and approval of INDs and NDAs
-Actively monitor and advise applicable team members and product managers of upcoming regulatory affairs deadlines and other critical dates (e.g. patent expiration)
-Proactively solicit regulatory su ... Read More
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