1.
| Contract Manager
Madison, NJ (0 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... |
2.
| Assistant/Assoc Dir,Health Outcomes
Kearny, NJ (15 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... |
3.
| Executive Medical Director
Greenville, NJ (18 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... |
4.
| Project Manager
Kingston, NJ (28 miles)
11/21/2009 full time
Pay rate: Open | The Cambridge Group Ltd. |
This position requires an understanding of the clinical regulatory and commercial requirements for early and late stage drug development. Good working knowledge of clinical operations and the regulatory process. ...level analytical skills to enable resolution of scientific medical regulatory resource and financial/business issues confronting the projects. Solid computer skills with demonstrated experience in working with MS Project and the... |
5.
| Director of Statistics
Bloomfield, NJ (12 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... |
6.
| Senior TA Statistician
Livingston, NJ (5 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... |
7.
| Associate Director or Director Regulatory Stragetic Research
Bridgewater, NJ (15 miles)
11/21/2009 full time
Pay rate: Competitive | Discovery Solutions, Inc. |
Responsible for mining all available public resources concerning regulatory agency positions/actions and providing articulate and concise summaries of that information as needed within the Company for inclusion in both regulatory... ...1.Resea rch FDA website to gather information as needed and as directed by Regulatory Management on oncology drug approval precedents and provide summaries of information
2.Research EMEA website to gather information as needed and as... |
8.
| Executive Dir, Pharmacovigilance (PVRM)
Greenville, NJ (18 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. |
9.
| Senior TA Statistician
Livingston, NJ (5 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... |
10.
| Document Control Specialist-II
Raritan, NJ (17 miles)
11/21/2009 7-12 mos. (contract)
Pay rate: Open | dinaliC LLC |
Evaluate new regulatory compliance and/or legal guidance and develop impact analysis and prepare implementation plans on process SOP and training as needed. ...SOPs using SOP WORD template ensures that SOPs meet all applicable regulatory financial and legal requirements and are consistent with the practices of Company other departments and Corporate and Pharmaceutical Group policies... |
11.
| Director Biostatistics
Fort Lee, NJ (24 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. |
12.
| Life Sciences Strategy & Operations Consulting Senior...
New York, NY (22 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... |
13.
| Clinical Research Manager
Livingston, NJ (5 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. |
14.
| Mgr, Clinical Contracting Excellence
Morristown, NJ (4 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. |
15.
| Scientific Medical Writer
Boonton, NJ (11 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... |
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16.
| Clinical Statisticion
Bridgewater, NJ (15 miles)
11/20/2009 full time
Pay rate: Competitive | Discovery Solutions, Inc. |
...of marketing applications NDA/BLA to FDA EMEA or other worldwide regulatory agencies Collaborate with internal Data Management professionals and/or manage Data Management and Biostatistical personnel at CROs Perform clinical data... ...marketing applications
3+ NDA/BLA submissions including FDA and other regulatory agency
3+ experience
Excellent communication and writing skills Excellent programming skills especially in SAS. S Plus is a plus
Experience with... |
17.
| ePRO Clinical Project Specialist
Bridgewater, NJ (15 miles)
11/20/2009 full time
Pay rate: Open | ERT |
Our team provides unparalleled scientific and regulatory leadership to pharmaceutical biotechnology contract research organizations CROs and medical device companies around the world. |
18.
| Senior Scientific Writer
Boonton, NJ (11 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... |
19.
| Medical Writer
Elizabeth, NJ (14 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. |
20.
| Clinical Study Manager
Edison, NJ (16 miles)
11/20/2009 full time
Pay rate: Open | Daiichi Sankyo |
...forth by the Product Development Plan and per Daiichi Sankyo procedures FDA regulations/EU Directive and ICH GCP Guidelines
Responsibilities Develop study implementation plan. |
21.
| Regulatory Affairs Associate Director - Support Services
Madison, NJ (0 miles)
11/20/2009 full time
Pay rate: Open | Bausch & Lomb Incorporated |
Position Summary
The Global Regulatory Affairs Support Services Associate Director provides leadership and direction for Pharmaceutical Regulatory • Operations? centers of excellence. Coordinates with other Bausch & Lomb regulatory functions to... ...? Serve as a leadership team member for Bausch & Lombs Pharmaceutical Regulatory Affairs function ? Manage the overall operations of Pharmaceutical Regulatory Affairs which is defined as the submissions publishing technology training and... |
22.
| Sr Administrative Assistant - Regulatory Affairs
Madison, NJ (0 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... |
23.
| Regulatory Affairs Associate Director - Brand
Madison, NJ (0 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 ? |
24.
| Sr. Principal Biostatistician
West Orange, NJ (8 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... |
25.
| Regulatory Affairs Manager - Submissions
Madison, NJ (0 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... |
26.
| Process Development Engineer
Orangeburg, NY (30 miles)
11/20/2009 full time
Pay rate: Open | Nice Pak |
Support validation of new processes and equipment. 6. Ensure regulatory and safety compliance. 7. Generate and maintain process development history files. 8. Write and ensure compliance with Operating procedures. ...experience in manufacturing with three years of process development experience in regulated/CGMP environment
Knowledge Required Individual must be able to work independently and possess strong written/oral communication skills. |
27.
| Regulatory Affairs Director
Madison, NJ (0 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... |
28.
| Regulatory Affairs Associate - State Licensing
Plainsboro, NJ (30 miles)
11/19/2009 full time
Pay rate: Open | Integra Corp. |
The Regulatory Affairs Associate State Regulations will provide support to Regulatory Affairs and the Integra Family of companies on state licensure and other state regulatory filings. Responsibilities will include coordinating drafting reviewing and... ...working on state compliance matters and any other matters that the Regulatory Affairs department may handle.
* Review draft and file state regulatory filings
* Manage complex cross divisional projects
* Monitor state regulatory laws... |
29.
| International Regulatory Affairs Associate
Plainsboro, NJ (30 miles)
11/19/2009 full time
Pay rate: Open | Integra Corp. |
Prepare regulatory submissions correspondence and reports for the companys Asian distributors. Maintains international regulations and approval lists for international product approvals based on U.S. ...Senior Management
* Coordinates the notarization and legalization of regulatory documents
* Maintains database of Asia distributors and registrations
* Maintains and updates list of international regulations and guidances as required... |
30.
| Exposure Scientist
Clinton, NJ (27 miles)
11/20/2009 full time
Pay rate: Open | ExxonMobil |
...science exposure factors and models for product safety assessment and regulatory requirements. The position encompasses occupational community consumer and environmental exposure assessment. ...across business areas trade groups and regulatory agencies. The position will require travel.
Candidates will have completed a MS or PhD in Environmental Science Public Health or other relevant discipline. |
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31.
| 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. |
32.
| Regulatory Affairs Assoc III
Morristown, NJ (4 miles)
10/7/2009 full time
Pay rate: Open | Watson Pharmaceuticals |
Job Title Regulatory Affairs Assoc III AutoReqId 6796BR Location Morristown NJ Department RegAffairs Gen Job Description
With annual revenues of over $2.5 billion at Watson Pharmaceuticals NYSE WPI we dedicate ourselves daily to a singular mission... ...and updates departmental SOPs performs special projects assigned by Regulatory Affairs management complies with good housekeeping and safety practices trains and coaches lower level Regulator Affairs Associates ensures project deadlines... |
33.
| Mgr, Regulatory Affairs
Morristown, NJ (4 miles)
10/7/2009 full time
Pay rate: Open | Watson Pharmaceuticals |
Job Title Mgr Regulatory Affairs AutoReqId 6795BR Location Morristown NJ Department RegAffairs Gen Job Description With annual revenues of over $2.5 billion at Watson Pharmaceuticals NYSE WPI we dedicate ourselves daily to a singular mission to improve... ...implements policies to assure on going compliance of Regulatory Affairs activities assesses impact of new regulations and suggests appropriate changes to business processes/policies as necessary interacts with the FDA to... |
34.
| Director, Environmental and Laundry Services
Princeton, NJ (29 miles)
10/8/2009 full time
Pay rate: Open | Medical Center at Princeton |
...regard to cleanliness safety quality control and compliance with regulatory and accreditation requirements at all Princeton HealthCare System properties. Specific duties and responsibilities include
• Plan organize... ...• Comply with all regulatory requirements and accreditation standards.
• Establish and implement policies and procedures for department operations.
• Establish... |
35.
| Senior Scientist, Global Drug Safety
Parsippany, NJ (7 miles)
10/15/2009 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. |
36.
| Manager, Sr. Manager, Regulatory Affairs
Bridgewater, NJ (15 miles)
10/17/2009 full time
Pay rate: Open | King Pharmaceuticals |
...current knowledge of PhRMA codes OIG and AMA guidelines Represent Regulatory Affairs and provide active participation in the Copy Clearance Committee CCC process by working with Legal Medical Marketing and Commercial Operations to... ...or related field and four to eight years of relevant experience in regulatory affairs or equivalent combination of education and experience is required for this position The successful candidate must have a thorough knowledge of pharmaceutical... |
37.
| Medical Science Liaison/Sr. Medical Science Liaison
New York, NY (22 miles)
10/17/2009 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... |
38.
| CUMC-ICM Animal Husbandry Technician Assistant
New York, NY (22 miles)
10/28/2009 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... |
39.
| Aviation Safety Inspector (Operations)
New York, NY (22 miles)
11/3/2009 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. |
40.
| Clinical - Clinical Research Project Manager II
Somerville, NJ (19 miles)
11/4/2009 full time
Pay rate: Open | Acro Service Corporation |
Other Required Skills and Abilities Knowledgeable in GCP guidelines and FDA/ICH regulations. Skilled in protocol informed consent and CRF development Experienced in study initiation and execution data management including EDC and CRO oversight. |
41.
| Technician B - Infectious Diseases
New York, NY (22 miles)
11/4/2009 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. |
42.
| Clinical Trial Associate
Jersey City, NJ (19 miles)
11/5/2009 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... |
43.
| Scientific - Clinical Research Associate - In-Hous
Skillman, NJ (27 miles)
11/11/2009 full time
Pay rate: Open | Acro Service Corporation |
Work to ensure that trials adhere to study protocols applicable SOPs FDA regulations International Conference for Harmonization/Good Clinical Practices guidelines and government regulations. |
44.
| Clinical Research Nurse Coordinator
New York, NY (22 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... |
45.
| Environmental Specialist
New York, NY (22 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. |
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46.
| Analytical Chemist
Picatinny Arsenal, NJ (14 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... |
47.
| Regulatory Affairs Senior Specialist - OTC/Nutritionals
Madison, NJ (0 miles)
11/20/2009 full time
Pay rate: Open | Bausch & Lomb Incorporated |
Position Summary
The Global Regulatory Affairs Senior Specialist handles activity for developing pharmaceutical regulatory strategies submissions and managing interactions with the regulatory agencies for OTC/Nutritional products.
Specific Job Duties
... ...regulatory aspects of product development team for agency filing ? Work with Regulatory Affairs Senior Manager for OTC/Nutritionals to make certain all product documentation is developed in accordance with regulatory requirements serve as designee... |
48.
| Postdoctoral Research Associate
Princeton, NJ (29 miles)
11/19/2009 full time
Pay rate: Open | Princeton University |
...bioinformatics and mouse genetics approaches to study genes and signaling pathways that regulate the multi step process of cancer metastasis see Hu et al. Cancer Cell 2009 Korpal et al. |
49.
| Regulatory Affairs Manager-Consumer Healthcare OTC
Roseland, NJ (7 miles)
11/20/2009 full time
Pay rate: Open | Schering-Plough |
Position Title Regulatory Affairs Manager Consumer Healthcare OTC Business Division Global Specialty Operations Consumer Healthcare Country U.S.A. Location NJ Roseland Job Description Meet the new Merck. ...The primary purpose of this position is to manage the regulatory affairs activities for product registrations worldwide. This responsibility is primarily divided into four general functions
? |
50.
| Quality Control Scientist III
Pearl River, NY (29 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... |
