1.
| Assistant/Assoc Dir,Health Outcomes
Kearny, NJ (30 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... |
2.
| Contract Manager
Madison, NJ (17 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.
| Corporate Director Safety Environmental Programs and...
Murray Hill, NJ (14 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. |
4.
| Clinical Research Scientist
East Hanover, NJ (22 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... |
5.
| Director, Environmental and Laundry Services
Princeton, NJ (14 miles)
11/22/2009 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... |
6.
| Senior Scientist, Global Drug Safety
Parsippany, NJ (23 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. |
7.
| Manager, Sr. Manager, Regulatory Affairs
Bridgewater, NJ (1 miles)
11/22/2009 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... |
8.
| Scientist 1
Cranbury, NJ (18 miles)
11/22/2009 full time
Pay rate: Open | ARCADIS |
* Background in permitting reporting and regulation interpretation managing and implementing EHS programs with an emphasis on EHS compliance preferred.
* Must be capable of working independently to efficiently... |
9.
| Clinical - Clinical Research Project Manager II
Somerville, NJ (2 miles)
11/22/2009 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. |
10.
| Scientist
Hamilton, NJ (24 miles)
11/22/2009 full time
Pay rate: Open | Pharmaceutical Product Development |
* Demonstration of good documentation practices as required in a cGMP/cGLP regulated laboratory * Demonstration of good interpersonal skills in a high throughput active Compedial laboratory including good communication with supervisors... |
11.
| Sr Principal Biostatistician
Florham Park, NJ (19 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 . |
12.
| Environmental Scientist
Hamilton, NJ (24 miles)
11/10/2009 full time
Pay rate: Open | Michael Baker Corporation |
Knowledgeable in NEPA regulations and the tenets of other environmental laws rules and regulations. Special skills needed for the position include competent technical writing skills... |
13.
| Director of Statistics
Bloomfield, NJ (28 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... |
14.
| Project Manager
Kingston, NJ (13 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... |
15.
| Executive Dir, Pharmacovigilance (PVRM)
Greenville, NJ (30 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. |
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16.
| Executive Medical Director
Greenville, NJ (30 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... |
17.
| Associate Director or Director Regulatory Stragetic Research
Bridgewater, NJ (1 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... |
18.
| Senior TA Statistician
Livingston, NJ (22 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... |
19.
| Document Control Specialist-II
Raritan, NJ (0 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... |
20.
| Senior TA Statistician
Livingston, NJ (22 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.
| Senior Scientific Writer
Boonton, NJ (26 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... |
22.
| Mgr, Clinical Contracting Excellence
Morristown, NJ (17 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. |
23.
| Clinical Research Manager
Livingston, NJ (22 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. |
24.
| ePRO Clinical Project Specialist
Bridgewater, NJ (1 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. |
25.
| Medical Writer
Elizabeth, NJ (25 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.
| Clinical Statisticion
Bridgewater, NJ (1 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... |
27.
| Scientific Medical Writer
Boonton, NJ (26 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.
| Sr. Principal Biostatistician
West Orange, NJ (24 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... |
29.
| Analytical Chemist
Picatinny Arsenal, NJ (25 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... |
30.
| Exposure Scientist
Clinton, NJ (16 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.
| International Regulatory Affairs Associate
Plainsboro, NJ (16 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... |
32.
| Postdoctoral Research Associate
Princeton, NJ (14 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. |
33.
| Scientific - Clinical Research Associate - In-Hous
Skillman, NJ (11 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. |
34.
| Regulatory Affairs Associate - State Licensing
Plainsboro, NJ (16 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... |
35.
| Regulatory Affairs Associate Director - Brand
Madison, NJ (17 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 ? |
36.
| Regulatory Affairs Director
Madison, NJ (17 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... |
37.
| Regulatory Affairs Manager - Submissions
Madison, NJ (17 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... |
38.
| Sr Administrative Assistant - Regulatory Affairs
Madison, NJ (17 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... |
39.
| Clinical Research Scientist
Morristown, NJ (17 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 (17 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.
| Process Engineer (IRC1174)
Plainsboro, NJ (16 miles)
11/19/2009 full time
Pay rate: Open | Integra LifeSciences |
...investigations and provide practical manufacturing solutions under appropriate regulatory guidelines for Medical Device Manufacture. * Work to gain expertise in Integra• Ts current technical proficiencies and manufacturing processes * Lead... ...functional working relationship with Manufacturing Plant Engineering Regulatory and Quality Assurance. * Ensure that all appropriate documentation drawings specifications are generates in compliance with Integra• Ts procedures... |
42.
| Manager, Quality Control - Microbiology
Morris Plains, NJ (20 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... |
43.
| Regulatory Affairs Associate Director,...
Madison, NJ (17 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 ? |
44.
| Process Engineer*
Branchburg, NJ (5 miles)
11/19/2009 full time
Pay rate: Open | AGFA Healthcare Corporation |
...in statistical techniques * Familiarity with safety environmental and health regulations * Strong leadership skills solid written and verbal communication problem solving project management and organizational skills including change management... |
45.
| Senior Program Manager - Drug Regulatory Affairs
Nutley, NJ (30 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
... |
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46.
| Manager, Regulatory Operations / Submissions
Bridgewater, NJ (1 miles)
11/18/2009 full time
Pay rate: Competitive | Discovery Solutions, Inc. |
The candidate works directly with various stakeholders within the Regulatory Affairs and with other appropriate internal departments Clinical Affairs Non clinical Manufacturing Information Technology Human Resources Finance and Legal... ...10.Assists with Senior Management requests from Regulatory CMC & Operations or Regulatory Affairs as needed.
ESSENTIAL KNOWLEDGE
SKILLS EXPERIENCE
1.Must have 3 5 years of pharmaceutical industry experience with a minimum of 2 years of regulatory... |
47.
| Senior Engineer III
SOMERVILLE, NJ (2 miles)
11/18/2009 4-6 mos. (contract)
Pay rate: $40 to $50 | dinaliC LLC |
Experience in Medical Device Design Control required. Strong analytical and communications skills are required.
Strong knowledge of and training in Quality Systems Regulations QSR preferred. |
48.
| Sr. Manager, Regulatory Affairs Archives
Bridgewater, NJ (1 miles)
11/18/2009 full time
Pay rate: Open | ImClone Systems |
Requisition # 414190 Job Title Sr. Manager Regulatory Affairs Archives Job Category Regulatory Country United States State New Jersey City Bridgewater Job Type Regular Relocation Work Shift 1st Shift Job Summary GENERAL SUMMARY The incumbent... ...GENERAL SUMMARY The incumbent is responsible for ensuring that records within Regulatory Affairs are being managed in compliance with regulations and archiving best practices. The Senior Manager will also have responsibility for the management of department... |
49.
| DIRECTOR IMMUNOLOGY, GCR
Princeton, NJ (14 miles)
11/18/2009 full time
Pay rate: Open | Bristol Myers Squibb |
...for a program by soliciting and integrating input from statistics regulatory outcomes research marketing and other experts. Ensures that studies are aligned with target label indications and commercial goals and are properly... ...scientific expertise to BMS colleagues in drug discovery labeling regulatory outcomes research and marketing/commercial departments. Provides scientific/medical input to and reviews various study plans e.g. |
50.
| EXECUTIVE DIRECTOR, GCR IMMUNOLOGY
Princeton, NJ (14 miles)
11/18/2009 full time
Pay rate: Open | Bristol Myers Squibb |
Work closely with colleagues in discovery early development regulatory global and regional medical affairs commercial and other key functional areas for the asset on a global basis. ...Partner closely with colleagues in discovery early development regulatory global and regional medical affairs commercial and other key functional areas on a global basis to help translate strategies into objectives and action... |
