1.
| Regulatory CMC Liaison/Biologics
Livingston, NJ (21 miles)
11/23/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
Regulatory CMC Liaison/Biologics
The successful candidate will provide biologics specific regulatory advice and creative solutions to fellow members of the Regulatory CMC Group based on a wealth of experience. ...Group based on a wealth of experience. The incumbent will also formulate lead and drive regional and/or global CMC regulatory biologics strategy for assigned development projects and/or marketed products with a focus on creativity and innovation... |
2.
| Contract Manager
Madison, NJ (25 miles)
11/22/2009 4-6 mos. (contract)
Pay rate: Open | The Cambridge Group Ltd. |
Collaborates cross functionally with company Legal Patents Regulatory Compliance and Insurance to negotiate contract wording changes. Works closely with Clinical Trial team to ensure delivery of fully executed contracts... |
3.
| Assistant/Assoc Dir,Health Outcomes
Kearny, NJ (21 miles)
11/22/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
...communication tools models slide kits Economic formulary dossier and regulatory submissions . Additional essential responsibilities include collaborating with internal and external co authors in drafting abstracts papers and reports... ...drafting submissions to regulatory agencies for outcomes labeling and drafting submissions to reimbursement authorities to secure patient access to Company products. A PhD M.D. or other medical related degree with graduate training in economics... |
4.
| Principal Scientist / Regulatory Affairs
Purchase, NY (23 miles)
11/22/2009 full time
Pay rate: Open | PepsiCo |
Job ID 21682 Job Title Principal Scientist / Regulatory Affairs Division PepsiCo Corporate Country United States of America State/Province New York City Purchase Relocation Available Yes Reg/Temp Regular Full Time Yes Date Posted Oct 16 2009 ... ...individual will establish relationships with regional scientific and regulatory affairs and food safety teams with R& D global project leaders and with other key contacts as required across functions.
This person will be an integral member... |
5.
| Clinical Trial Associate
Jersey City, NJ (22 miles)
11/22/2009 full time
Pay rate: Open | Kforce Inc. |
...trial start up conduct and close out activities * Collect and review regulatory documents from clinical sites * Initiate maintain and reconcile the Trial Master File * Organize and maintain tracking systems and tools to support the... ...combination of education and experience * Knowledge of ICH/GCP * Training in Regulatory Compliance * Proficient computer skills across multiple applications * Effective written and verbal communication skills * Good judgment in triaging calls... |
6.
| Corporate Director Safety Environmental Programs and...
Murray Hill, NJ (29 miles)
11/22/2009 full time
Pay rate: Open | C. R. Bard, Inc. |
* Promote safety regulatory compliance and environmental sustainable development as core values within C.R. Bard. * Direct and manage projects to address the issues identified in... ...environmental structure exists at each location to ensure compliance with regulatory requirements. * Coordinate and manage all environmental and safety reporting for C.R. Bard. |
7.
| Technician B - Infectious Diseases
New York, NY (23 miles)
11/22/2009 full time
Pay rate: Open | Columbia University |
Maintains laboratory equipment. Complies with safety regulations. Provides quality control. Performs other related duties including animal studies necessary to the functioning of the laboratory research projects or work unit. |
8.
| Medical Science Liaison/Sr. Medical Science Liaison
New York, NY (23 miles)
11/22/2009 full time
Pay rate: Open | King Pharmaceuticals |
...one to one settings in accordance with Company Policies and applicable laws regulations and ethical standards Demonstrates effective listening skills by allowing Healthcare providers to express their opinions and provides appropriate response... ...their background use in accordance with Company Policies and applicable laws regulations and ethical standards Participates in any type of internal training format or venue according to training direction Demonstrates the ability to train... |
9.
| Senior Scientist, Global Drug Safety
Parsippany, NJ (19 miles)
11/22/2009 full time
Pay rate: Open | The Medicines Company |
• A keen ongoing interest in medicine pharmaceuticals and regulatory affairs is essential for maintaining quality performance in this position and continuing education in these areas is encouraged. |
10.
| Clinical Research Scientist
East Hanover, NJ (20 miles)
11/22/2009 full time
Pay rate: Open | Novartis Pharmaceuticals Corporation |
...clinical team members clinical operations scientific operations regulatory affairs data management and finance regarding day to day activities of clinical trials. 3. Serve as Local Trial Leader for non registration US Medical Affairs... |
11.
| Aviation Safety Inspector (Operations)
New York, NY (23 miles)
11/22/2009 full time
Pay rate: Open | Federal Aviation Administration |
...air carriers operators agencies and airmen operating under Federal Aviation Regulations FAR Parts 91 121 124 129 135 and 141. Identifies and establishes work programs for inspection and surveillance within manpower and budget limitations. ...Evaluates manuals and training programs to insure that FAA regulations are met. Monitor all phases of operations including training programs and records base and station facilities and route systems. |
12.
| CUMC-ICM Animal Husbandry Technician Assistant
New York, NY (23 miles)
11/22/2009 full time
Pay rate: Open | Columbia University |
...appropriate manner using established procedures as prescribed by federal laws and regulations state law and Columbia Health Sciences Division policy. The Animal Husbandry Technician Assistant may perform multiple assignments as a trainee under... |
13.
| Sr. Project Scientist
Allendale, NJ (3 miles)
11/22/2009 full time
Pay rate: Open | Energizer |
...developing and launching an OTC type product familiarity with sunscreen regulatory
elements is a plus
? Experience with international sun care formulations is a plus.
? Practical background in statistical evaluations
? |
14.
| Internl Regulatory Affairs Mgr - Asia
Allendale, NJ (3 miles)
11/22/2009 full time
Pay rate: Open | Energizer |
International Regulatory Affairs Manager Asia
The Energizer Personal Care Division of Energizer Holdings Inc. is a leading manufacturer and distributor of a diverse portfolio of consumer and personal products. ...Assist with the training of regulatory affairs personnel and provide work direction on projects. Assure all governmental and industry reporting systems and documentation comply with regulatory requirements... |
15.
| Sr Principal Biostatistician
Florham Park, NJ (23 miles)
11/22/2009 full time
Pay rate: Open | Novartis Pharmaceuticals Corporation |
5. Follow processes and adhere to Novartis and project specific standards as well as Health Authority requirements SOPs NIPs Master Analysis Plan GCP and regulatory guidelines . |
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16.
| Director of Regulatory Affairs
Wayne, NJ (9 miles)
11/22/2009 full time
Pay rate: Open | MAQUET Gmbh & Co. |
PURPOSE OF POSITION
Effectively participate in the development and implementation of regulatory compliance programs to ensure compliance with all applicable federal state and international standards/regulations related to the Marketing Sale ... ...Provide oversight to the preparation submission and alignment of the regulatory documentation to FDA 510 k s PMAs IDEs MDRs etc to enable clearance of products in accordance with MAQUET Medical Systems and US Sales/Marketing strategies. |
17.
| Senior TA Statistician
Livingston, NJ (21 miles)
11/21/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
Authority requirements SOP's NIP's Master Analysis Plan GCP and regulatory guidelines participate in or lead non clinical activities as needed S&SR team and establish and maintain sound working relationships and effective... |
18.
| Executive Dir, Pharmacovigilance (PVRM)
Greenville, NJ (26 miles)
11/21/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
Oversee analysis documentation and coordination of responses through Regulatory Affairs for NDA product defense of safety specific FDA requests. Identify and address needs for additional research or epidemiological studies. ...will also liaise on an ongoing basis with Clinical Development and Regulatory Affairs on the medical safety aspects of company products and the profiling of company products and reports. |
19.
| Director Biostatistics
Fort Lee, NJ (18 miles)
11/21/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
The successful candidate will demonstrate solid interpersonal and organization skills in team settings and have experience with Regulatory submissions. |
20.
| Senior TA Statistician
Livingston, NJ (21 miles)
11/21/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
Authority requirements SOP's NIP's Master Analysis Plan GCP and regulatory guidelines participate in or lead non clinical activities as needed S&SR team and establish and maintain sound working relationships and effective... |
21.
| Director of Statistics
Bloomfield, NJ (18 miles)
11/21/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
...industry experience with clinical trials including interaction with regulatory agencies especially FDA knowledge of the guidelines of worldwide regulatory agencies and the ability to lead and advise the Global Project Teams and... |
22.
| Executive Medical Director
Greenville, NJ (26 miles)
11/21/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
A track record of regulatory interaction and submission experience. Expertise in therapeutic area or broad medical knowledge. ...mentoring clinical research physicians and medical monitors. Established authorship and review of documents for regulatory submission. The candidate must have the ability to supervise and mentor team of clinical research physicians and medical... |
23.
| Life Sciences Strategy & Operations Consulting Senior...
New York, NY (23 miles)
11/21/2009 full time
Pay rate: Open | Deloitte |
...experience with clinical trials acommercialization strategy and/or R&D regulatory requirements.aaExtensive domestic travel to client locations is required. a a Ideal Senior Manager candidates will have demonstrated experience in the... |
24.
| Mgr, Clinical Contracting Excellence
Morristown, NJ (25 miles)
11/20/2009 4-6 mos. (contract)
Pay rate: Open | The Cambridge Group Ltd. |
...respond to the changing needs & requirements legal operational regulatory & financial of our internal & external customers worldwide. Lead the CRO/Central Lab/Reference Lab and Specialty provider selection process on a study... ...Minimize regulatory legal and financial risks. Produce final contracts/amendments and secure all necessary company approvals to ensure SOX compliance. |
25.
| Medical Writer
Elizabeth, NJ (28 miles)
11/20/2009 4-6 mos. (contract)
Pay rate: Open | The Cambridge Group Ltd. |
Seeking a contract medical writer to write and QC regulatory submissions clinical study reports investigator brochures and integrated summaries. Work must be performed primarily on site.
Requirements At least... ...experience in clinical writing for regulatory submissions including clinical study reports investigator brochures and integrated summaries. Advanced degree in Life Sciences preferably PhD or PharmD
The Cambridge Group Ltd. |
26.
| Senior Scientific Writer
Boonton, NJ (17 miles)
11/20/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
Senior Scientific Writer
The Senior Scientific Writer is the medical writing expert responsible for the research writing and editing of regulatory documents. The incumbent will provide full lifecycle support from clinical study protocols through... ...will include participating in the development of the strategy of the submission and the label and the carrying through of those key messages into other regulatory documents assuring quality and timely preparation of clinical documents across all... |
27.
| Scientific Medical Writer
Boonton, NJ (17 miles)
11/20/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
Scientific Medical Writer
The Scientific Writer is the medical writing expert responsible for the research writing and editing of regulatory documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory... |
28.
| Clinical Research Manager
Livingston, NJ (21 miles)
11/20/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
...effectively and is able to establish relationships with other line functions.
Candidate must have excellent knowledge in worldwide regulatory requirements for drug registration and global cross cultural perspective and customer orientation. |
29.
| Environmental Specialist
New York, NY (23 miles)
11/20/2009 full time
Pay rate: Open | conEdison, inc. |
Candidate must posess five years work experience in regulatory compliance environmental science safety industrial hygiene waste handling or site management. Must have a proven track record and be able to work independently. ...effectively interact with union employees support staff contractors regulatory agencies and various levels of mangement. Must have completed or be able to complete within 1 year EH& S certification programs. |
30.
| Analytical Chemist
Picatinny Arsenal, NJ (22 miles)
11/20/2009 full time
Pay rate: Open | SAIC |
*Due to Federal contract regulations U.S. citizenship is required* REQUIRED EDUCATION/SKILLS Bachelors of Science degree in Chemistry or other related field and at least 3 years of experience... |
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31.
| Quality Control Scientist III
Pearl River, NY (7 miles)
11/19/2009 full time
Pay rate: Open | Pfizer |
...investigational in nature and are performed in compliance with USP FDA and other regulatory body requirements Pfizer standard operating procedures and approved license requirements. ...knowledge of 1 applicable compliance guidelines of the FDA or other regulatory bodies 2 test procedures such as USP NF and ASC and 3 relevant Pfizer SOPs.
? Extensive knowledge and practical application of relevant analytical... |
32.
| Regulatory Affairs Associate Director - Brand
Madison, NJ (25 miles)
11/20/2009 full time
Pay rate: Open | Bausch & Lomb Incorporated |
Liaise with Bausch & Lomb country specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations ? Manage interactions with other Bausch & Lomb functions e.g. ...Technical Competencies
? Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle including Development Promotion and Advertising Labeling CMC Commercialization and Operations ? |
33.
| Regulatory Affairs Manager - Submissions
Madison, NJ (25 miles)
11/20/2009 full time
Pay rate: Open | Bausch & Lomb Incorporated |
Position Summary
The Global Regulatory Affairs Submission Manager is responsible for working to execute timely and accurate product registrations. Responsible for working with the Advertising and Promotion Senior Manager and Labeling Senior Manager to... ...being performed by contract vendors
* Liaise with country specific regulatory affairs submission personnel
* Provide information for pharmaceutical product registrations
* Responsible for preparing for global product registration variations... |
34.
| Sr. Principal Biostatistician
West Orange, NJ (20 miles)
11/19/2009 full time
Pay rate: Open | Kforce Inc. |
Health Authority requirements SOPs NIPs Master Analysis Plan GCP and regulatory guidelines . * Participate in or lead non clinical activities as needed. Requirements Experience For you to be the successful candidate we are looking... |
35.
| Regulatory Affairs Director
Madison, NJ (25 miles)
11/20/2009 full time
Pay rate: Open | Bausch & Lomb Incorporated |
Position Summary
The Global Regulatory Affairs Director manages all regulatory aspects of Bausch & Lombs pharmaceutical products throughout their lifecycle which includes Brand Generics OTC/Nutritionals and dietary supplements. ...Leads Regulatory Affairs personnel associated with the Pharmaceutical product lifecycle which includes but is not limited to Regulatory Product Development Advertising and Promotion... |
36.
| Sr Administrative Assistant - Regulatory Affairs
Madison, NJ (25 miles)
11/20/2009 full time
Pay rate: Open | Bausch & Lomb Incorporated |
* Provides administrative support to the Vice President Regulatory Affairs and the Regulatory Affairs group based in Madison NJ.
* Duties include but not limited to calendar management conference calls ensure that international/domestic travel arrangements... |
37.
| Assistant to Higher Education Officer/Environmental...
Long Island City, NY (25 miles)
11/19/2009 full time
Pay rate: Open | LaGuardia Community College |
...devising compliance strategy and program development for OSHA/PESH standards EPA regulations and New Yorks occupational and environmental regulations. Facilitate workshops meetings and seminars Prepare and deliver training Coordinate and... ...Knowledge of federal state and city health and safety regulations and requirements and experience in development and preparation of health and safety manuals and programs. |
38.
| Clinical Research Nurse Coordinator
New York, NY (23 miles)
11/11/2009 full time
Pay rate: Open | Columbia University |
...specimens maintaining databases preparing/monitoring study budgets and regulatory documents for IRB submission and preparing/attending audits if required.
The coordinator will consult with medical records of outlying clinics and hospitals... |
39.
| Clinical Research Scientist
Morristown, NJ (25 miles)
11/19/2009 4-6 mos. (contract)
Pay rate: Open | The Cambridge Group Ltd. |
...clinical trials preparation of required study documents including regulatory documents and assuring that data is collected according to company Standard Operating Procedures. ...Working knowledge of GCP and local regulatory requirements is desired.
The Cambridge Group Ltd. offers our contract employees a cafeteria style flexible benefits plan where consultants can choose from
... |
40.
| Drug Supply Mgmt Third Party Operations Mgr
Morristown, NJ (25 miles)
11/19/2009 4-6 mos. (contract)
Pay rate: Open | The Cambridge Group Ltd. |
Knowledge of relevant GxPs and applicable multinational regulations.
The Cambridge Group Ltd. offers our contract employees a cafeteria style flexible benefits plan where consultants can choose from
Two different... |
41.
| Home-based Regional Transplant CRA
New York, NY (23 miles)
11/19/2009 4-6 mos. (contract)
Pay rate: Open | The Cambridge Group Ltd. |
...to agreed timelines and budget ensuring adherence to international and local regulations and company SOP standards. Demonstrate exceptional customer focus as evidenced by positive feedback from internal colleagues and external customers Investigators... ...experience in international standards GCP/ICH international FDA EMEA and local regulations. Expertise in communication managing multiple priorities and computer literacy.
The Cambridge Group Ltd. |
42.
| Regulatory Affairs Associate Director,...
Madison, NJ (25 miles)
11/17/2009 full time
Pay rate: Open | Bausch & Lomb Incorporated |
Specific Job Duties
? Represent Regulatory Affairs on the promotional review team to make certain all pharmaceutical advertising and promotional materials are in compliance with regulatory requirements... ...personnel
Technical Competencies
? Knowledge of pharmaceutical industry regulatory affairs discipline ? Knowledge of laws regulations and guidance in relations to pharmaceutical products ? |
43.
| Senior Program Manager - Drug Regulatory Affairs
Nutley, NJ (17 miles)
11/19/2009 full time
Pay rate: Open | Roche |
Job ID 00017965 Senior Program Manager Drug Regulatory Affairs Job facts Job function Development Location United States New Jersey Nutley Company/ Division Pharmaceuticals Schedule Full time Job type Standard Service How to apply Apply online Print
... |
44.
| Manager, Quality Control - Microbiology
Morris Plains, NJ (23 miles)
11/19/2009 full time
Pay rate: Open | Dendreon Corporation |
...in support of Dendreons products and in accordance with appropriate regulatory corporate and scientific guidelines. The successful candidate will manage the Microbiology Laboratory operations on a daily basis as well as during inspections/audi... ...inspections/audits by the FDA and other regulatory agencies. This person leads develops and mentors reporting staff at a variety of levels. The ability to function in a fast paced highly technical environment and communicate effectively is essential... |
45.
| Scientist
New York, NY (23 miles)
11/10/2009 full time
Pay rate: Open | conEdison, inc. |
...on issues requiring oversight of federal and state natural resource regulatory matters. The Scientist must be able to provide interpretative analyses of laws and policies as they relate to Company operations. ...determine the applicability of any local ordinances pertaining to these subject matters. The Scientist must understand the regulatory process and support the Sr. Scientist in monitoring the impacts of regulatory changes on company operations. |
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46.
| Senior Safety, Environmental and Health Leader
Englewood Cliffs, NJ (17 miles)
11/18/2009 full time
Pay rate: Open | Ben and Jerry's |
Environmental Process ensuring that the site SHE Management System meets regulatory & Unilever requirements effectively controls SHE risks and delivers continuous improvement in SHE performance. ...Effectively Interfacing with outside regulatory agencies Corporate SHE personnel Legal. Key Relationships 1. Interacting with and advising senior site leadership on SHE issues 2. |
47.
| Clinical Research Manager
New York, NY (23 miles)
11/17/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
Research Manager
As an integral member of the research team at 2 Regional Sites and in compliance with all regulatory institutional and departmental requirements manages the functions and activities of assigned services within the division's... |
48.
| QA Inspector-Visual
Mahwah, NJ (0 miles)
11/17/2009 full time
Pay rate: $17-19 | SmartStaff Personnel |
Perform visual product verification inspection examination to certify visual conformance of four to five dimensional measurements including bar codes, lot codes, finishes, etc. Must have prior medical device or pharmaceutical background. This is a hands-on inspection job requiring current or recent hands-on experience.... |
49.
| Clinical Research Scientist II
Morristown, NJ (25 miles)
11/17/2009 7-12 mos. (contract)
Pay rate: Open | The Cambridge Group Ltd. |
...clinical trials preparation of required study documents including regulatory documents and assuring that data is collected according to company Standard Operating Procedures. ...Working knowledge of GCP and local regulatory requirements is desired.
The Cambridge Group Ltd. offers our contract employees a cafeteria style flexible benefits plan where consultants can choose from
... |
