1.
| Associate Director or Director Regulatory Stragetic Research
Bridgewater, NJ (18 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... |
2.
| Project Manager
Kingston, NJ (3 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... |
3.
| Document Control Specialist-II
Raritan, NJ (16 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... |
4.
| Associate Director for Laboratory Animal Medicine*
Philadelphia, PA (27 miles)
11/21/2009 full time
Pay rate: Open | Children's Hospital of Philadelphia |
Knowledge of regulatory and compliance requirements related to animals care/use in research. Job Description The Childrens Hospital of Philadelphia Research Institute is an interdisciplinar... ...animal care staff and assist the director in ensuring compliance with federal regulations and AAALAC international standards. The Associate Director for Laboratory Animal Medicine will report to the Director of Laboratory Animal Services. |
5.
| RESEARCH ASSISTANT II
Philadelphia, PA (27 miles)
11/21/2009 full time
Pay rate: Open | Children's Hospital of Philadelphia |
...issues and guidelines Elements of Informed Consent FDA Codes and Regulatory Issues. Job Description Assists the Radiology Department in data processing of proton spectroscopy and tasks related to setting up data analysis for studies... |
6.
| Clinical Research Nurse Coord
Philadelphia, PA (27 miles)
11/21/2009 full time
Pay rate: Open | Children's Hospital of Philadelphia |
...on and have full understanding of good clinical practices GCP and regulatory responsibilities and will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge... |
7.
| Clinical Statisticion
Bridgewater, NJ (18 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... |
8.
| ePRO Clinical Project Specialist
Bridgewater, NJ (18 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. |
9.
| Sr Administrative Assistant - Regulatory Affairs
Madison, NJ (30 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... |
10.
| Process Engineer
Cranbury, NJ (3 miles)
11/20/2009 full time
Pay rate: Open | Illinois Tool Works Inc. |
* 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
... ...Familiarity with safety environmental and health regulations Strong leadership skills solid written and verbal communication problem solving project management and organizational skills including... |
11.
| Clinical Research Assit I
Philadelphia, PA (27 miles)
11/20/2009 full time
Pay rate: Open | Children's Hospital of Philadelphia |
Duties include management of regulatory and trial documentation clinical trial data and specimen coordination. JOB SPECIFIC STANDARDS 1. |
12.
| Entry Level Environmental Staff Scientist ? Philadelphia, PA
Philadelphia, PA (27 miles)
11/19/2009 full time
Pay rate: Open | CH2M Hill |
...collection and have significant interaction with both clients and the regulatory community.
* Assist with regulatory documentation development including FERC documents Environmental Assessments Environmental Impact Statements siting... ...and state equivalents USACE 404 wetland permitting Federal Energy Regulatory Commission FERC filings Clean Water Act Clean Air Act and RCRA environmental permitting SPCC plan preparation and Storm Water Pollution Prevention... |
13.
| Entry Level Environmental Staff Scientist - Philadelphia, PA
Philadelphia, PA (27 miles)
11/20/2009 full time
Pay rate: Open | CH2M HILL |
...collection and have significant interaction with both clients and the regulatory community. * Assist with regulatory documentation development including FERC documents Environmental Assessments Environmental Impact Statements siting... ...and state equivalents USACE 404 wetland permitting Federal Energy Regulatory Commission FERC filings Clean Water Act Clean Air Act and RCRA environmental permitting SPCC plan preparation and Storm Water Pollution Prevention... |
14.
| Entry Level Environmental Staff Scientist - Philadelphia, PA
Philadelphia, PA (27 miles)
11/20/2009 full time
Pay rate: Open | CH2M HILL |
...collection and have significant interaction with both clients and the regulatory community. * Assist with regulatory documentation development including FERC documents Environmental Assessments Environmental Impact Statements siting... ...and state equivalents USACE 404 wetland permitting Federal Energy Regulatory Commission FERC filings Clean Water Act Clean Air Act and RCRA environmental permitting SPCC plan preparation and Storm Water Pollution Prevention... |
15.
| Exposure Scientist
Clinton, NJ (28 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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16.
| Clinical Study Manager
Edison, NJ (15 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. |
17.
| Scientist
Hamilton, NJ (11 miles)
11/5/2009 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... |
18.
| Scientific - Clinical Research Associate - In-Hous
Skillman, NJ (8 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. |
19.
| Regional Clinical Research Associate
Philadelphia, PA (27 miles)
11/19/2009 full time
Pay rate: Open | Kforce Inc. |
...accountability as well as manage investigational site to ensure compliance with FDA regulations ICH/GCP guidelines and company SOPs. This position is home based and requires over 50% travel. |
20.
| Regulatory Affairs Manager - Submissions
Madison, NJ (30 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... |
21.
| CMC Liaison - Pain - Global Regulatory Affairs
Trenton, NJ (12 miles)
11/20/2009 full time
Pay rate: Open | Sandoz Inc |
• Manages all regulatory interactions between Global Regulatory Affairs Categories GRA and the GRA CMC organization for the allocated category/ies. • Ensures high quality level liaison with HAs either directly with FDA... ...• Supports global and regional regulatory affairs associates for life cycle maintenance of marketed products renewal variations within teh alloacted Category/ies. |
22.
| Post Doc Fellow
Philadelphia, PA (27 miles)
11/4/2009 full time
Pay rate: Open | Children's Hospital of Philadelphia |
The Postdoctoral candidate will investigate signaling pathways regulating neutrophil and natural killer T NKT cell development and activation. Our laboratory is using a combination of molecular biochemical and mouse genetic... |
23.
| Postdoctoral Research Associate
Princeton, NJ (5 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. |
24.
| Regulatory Affairs Director
Madison, NJ (30 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... |
25.
| Regulatory Affairs Director - Policy & Communications
Madison, NJ (30 miles)
11/20/2009 full time
Pay rate: Open | Bausch & Lomb Incorporated |
Position Summary
The Regulatory Affairs Policy and Communication Director serves as the primary individual for regulatory intelligence for all Bausch & Lomb pharmaceutical products globally. ...? Serve as a leadership team member for Bausch & Lomb Pharmaceutical Regulatory Affairs function ? Monitor the domestic and international regulatory landscape including governmental and non governmental regulations practices and guidance... |
26.
| Regulatory Affairs Associate Director - Support Services
Madison, NJ (30 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... |
27.
| Regulatory Affairs Senior Specialist - OTC/Nutritionals
Madison, NJ (30 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... |
28.
| International Regulatory Affairs Associate
Plainsboro, NJ (0 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... |
29.
| Regulatory Affairs Associate - State Licensing
Plainsboro, NJ (0 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... |
30.
| Regulatory Affairs Associate Director - Brand
Madison, NJ (30 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 ? |
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31.
| Clinical Research Associate
Philadelphia, PA (27 miles)
11/19/2009 full time
Pay rate: Open | Children's Hospital of Philadelphia |
Internal Promotes good clinical practices by possessing an in depth knowledge of evidence based individual group and family therapy strategies and federal regulations and guidance documents for the conduct of clinical trials and human subject protection. |
32.
| Director, Environmental and Laundry Services
Princeton, NJ (5 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... |
33.
| Manager, Sr. Manager, Regulatory Affairs
Bridgewater, NJ (18 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... |
34.
| Scientist 1
Cranbury, NJ (3 miles)
10/28/2009 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... |
35.
| Clinical - Clinical Research Project Manager II
Somerville, NJ (15 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. |
36.
| Clinical Research Assit I
Philadelphia, PA (27 miles)
11/4/2009 full time
Pay rate: Open | Children's Hospital of Philadelphia |
Duties include management of regulatory and trial documentation clinical trial data and specimen coordination. JOB SPECIFIC STANDARDS 1. |
37.
| Post Doc Fellow
Philadelphia, PA (27 miles)
11/19/2009 full time
Pay rate: Open | Children's Hospital of Philadelphia |
The Postdoctoral candidate will investigate signaling pathways regulating neutrophil and natural killer T NKT cell development and activation. Our laboratory is using a combination of molecular biochemical and mouse genetic... |
38.
| Process Engineer*
Branchburg, NJ (14 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... |
39.
| Process Engineer (IRC1174)
Plainsboro, NJ (0 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... |
40.
| Regulatory Affairs Associate Director,...
Madison, NJ (30 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 ? |
41.
| Director of Clinical Trial Financial Management
Philadelphia, PA (27 miles)
11/19/2009 full time
Pay rate: Open | Children's Hospital of Philadelphia |
...clinical trial billing and collections in accordance with government and sponsor regulations includes oversight of the Billing Issue Resolution process 4 directing and designing the clinical trial participant tracking module in Click Commerce... |
42.
| Manager, Regulatory Operations / Submissions
Bridgewater, NJ (18 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... |
43.
| Senior Engineer III
SOMERVILLE, NJ (15 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. |
44.
| Sr. Manager, Regulatory Affairs Archives
Bridgewater, NJ (18 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... |
45.
| DIRECTOR, IMMUNOLOGY, GCR
Princeton, NJ (5 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. |
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46.
| EXECUTIVE DIRECTOR, GCR IMMUNOLOGY
Princeton, NJ (5 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... |
47.
| DIRECTOR IMMUNOLOGY, GCR
Princeton, NJ (5 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. |
48.
| Regulatory Affairs CMC / BLA
Bridgewater, NJ (18 miles)
11/17/2009 full time
Pay rate: Competitive | Discovery Solutions, Inc. |
Currently looking for a Manager and Director Regulatory Affairs CMC
Advanced knowledge of regulations guidance documents and corporate/industry standards and an ability to evaluate same for impact on strategic plans... ...Represents CMC Regulatory Affairs internally and facilitates communication with external parties including health authorities. |
49.
| Director, Regulatory Affairs (Strategy)
Bridgewater, NJ (18 miles)
11/17/2009 full time
Pay rate: Competitive | Discovery Solutions, Inc. |
Currently looking for a Director Regulatory Affairs
GENERAL SUMMARY
Directly responsible for the organization and preparation of IND/CTA submissions. ...EXPERIENCE
1.BS/MS in life science with minimum of 5 years experience in regulatory affairs
2.Must possess a thorough understanding of the drug development/regulatory process with stong experience in biologic oncology development.
3.Experience... |
50.
| Manager, Regulatory Affairs
Bridgewater, NJ (18 miles)
11/17/2009 full time
Pay rate: Competitive | Discovery Solutions, Inc. |
IND BLA and sBLA CTD/eCTD requirements and be familiar with global regulatory affairs workflow.
4. Knowledge of FDA EMEA websites and expertise in the ability to navigate.
5. Experience in managing regulatory information databases.
... ...8. Education requirements Bachelor of Science with 9 14 years of relevant pharmaceutical industry experience. Minimum of 5 years regulatory experience or equivalent is required. |
