Date:
Feb 27, 2014
Location
Raritan, NJ, US
Johnson & Johnson companies are equal opportunity employers.
2014 Janssen R&D Global Regulatory Affairs - NJ - Summer Interns(Job Number: 00000M22)
Description
Janssen Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is seeking Global Regulatory Affairs (GRA) Summer Interns to be based in NJ (Raritan or Titusville). The duration of this Summer Internship is June through August 2014.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The summer intern program will allow the students to blend real work experience with an extensive overview of the Pharmaceutical Industry. Knowledgeable mentors will provide guidance while gaining professional hands-on experience. The selected candidates will gain a better understanding of the role of GRA in the drug development process.
GRA understands and interprets global regulatory requirements and enables J&J Pharma to meet those guidelines. We are therefore able to drive the development of regulatory strategy for products from all therapeutic areas as well as high quality, on-time submissions to regulatory authorities.
Opportunities for the interns exist at our NJ facilities in the following groups:
Hematology-Oncology Therapeutic Area
The selected students will be working in this therapeutic area to gain experience and exposure in the Oncology drug developments with a goal to address the unmet medical need globally. The intern will assume a primary role in projects working either independently or as part of a team, as well as perform other activities that will support the policies and procedures of the area they are assigned to.
The summer interns will work with the assigned Regulatory Leader (RL) and/or Global Regulatory Leader (GRL)/Regulatory Professionals for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Oncology TA.
They will be responsible for the critical review of submission documents to ensure compliance with regulatory requirements. They will work with the RL/GRL/RP to understand the competitive landscape, e.g., views of HA, regulatory precedents, labeling differences and therapeutic area issues. Keeps abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidance’s and requirements related to those areas.
May provide input to Standard Operating Procedure documents to ensure accuracy and compliance.
Global Labeling Centre of Excellence
The interns will have the opportunity to learn and work on projects that cover the end-to-end labeling process throughout the product’s lifecycle -- from target labeling through CCDS, implementation and maintenance of the labeling and related packaging components that deliver comprehensive high quality, global labeling services to the therapeutic areas, established products, and regions and supporting affiliates
Position Responsibilities
Works on projects that will help develop analytical, audit, research, testing and validation skills.
Attend and participle in department meetings.
Develop and maintain documentation and forms.
Use Excel, Word, Project Management, or Visio to create correspondence, spreadsheets, forms, graphs, flowcharts, etc.
Provide customer service to the department’s internal and external customers.
Ensure compliance with all relevant quality, regulatory and legal requirements.
Other duties as assigned by the supervisor.
Qualifications
Candidates must be enrolled (not necessarily taking classes) in an accredited pharmacy college throughout the duration of the internship (June to August 2014). Only students that are in their first or second professional years will be considered. Previous co-op or internship experience is preferred, but not required. Students must have the ability to work full-time during the session. A minimum GPA of 3.2 is preferred. Local travel may be required.
Other required skills are:
Proficiency in MS Office Suite
Skills for word processing, spreadsheets, graphs and flowcharting
Attention to detail
Time management skills
Oral and written communication skills
Organizational skills
Students must be able to provide their own transportation to/from their work location. Students must be legally authorized to work in the United States and not require future sponsorship for employment visa status (e.g. H1-B status) now or in the future.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-New Jersey-Raritan
Other Locations:Add Location, North America-United States-New Jersey-Titusville
Organization: Janssen Research & Development, LLC. (6084)
Job: R&D
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Nearest Major Market: New Jersey
Job Segment: Neurology, Gastroenterology, Hematology, Immunology, Medical, Healthcare
2014 Janssen R&D Global Regulatory Affairs - NJ - Summer Interns(Job Number: 00000M22)
Description
Janssen Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is seeking Global Regulatory Affairs (GRA) Summer Interns to be based in NJ (Raritan or Titusville). The duration of this Summer Internship is June through August 2014.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The summer intern program will allow the students to blend real work experience with an extensive overview of the Pharmaceutical Industry. Knowledgeable mentors will provide guidance while gaining professional hands-on experience. The selected candidates will gain a better understanding of the role of GRA in the drug development process.
GRA understands and interprets global regulatory requirements and enables J&J Pharma to meet those guidelines. We are therefore able to drive the development of regulatory strategy for products from all therapeutic areas as well as high quality, on-time submissions to regulatory authorities.
Opportunities for the interns exist at our NJ facilities in the following groups:
Hematology-Oncology Therapeutic Area
The selected students will be working in this therapeutic area to gain experience and exposure in the Oncology drug developments with a goal to address the unmet medical need globally. The intern will assume a primary role in projects working either independently or as part of a team, as well as perform other activities that will support the policies and procedures of the area they are assigned to.
The summer interns will work with the assigned Regulatory Leader (RL) and/or Global Regulatory Leader (GRL)/Regulatory Professionals for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Oncology TA.
They will be responsible for the critical review of submission documents to ensure compliance with regulatory requirements. They will work with the RL/GRL/RP to understand the competitive landscape, e.g., views of HA, regulatory precedents, labeling differences and therapeutic area issues. Keeps abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidance’s and requirements related to those areas.
May provide input to Standard Operating Procedure documents to ensure accuracy and compliance.
Global Labeling Centre of Excellence
The interns will have the opportunity to learn and work on projects that cover the end-to-end labeling process throughout the product’s lifecycle -- from target labeling through CCDS, implementation and maintenance of the labeling and related packaging components that deliver comprehensive high quality, global labeling services to the therapeutic areas, established products, and regions and supporting affiliates
Position Responsibilities
Works on projects that will help develop analytical, audit, research, testing and validation skills.
Attend and participle in department meetings.
Develop and maintain documentation and forms.
Use Excel, Word, Project Management, or Visio to create correspondence, spreadsheets, forms, graphs, flowcharts, etc.
Provide customer service to the department’s internal and external customers.
Ensure compliance with all relevant quality, regulatory and legal requirements.
Other duties as assigned by the supervisor.
Qualifications
Candidates must be enrolled (not necessarily taking classes) in an accredited pharmacy college throughout the duration of the internship (June to August 2014). Only students that are in their first or second professional years will be considered. Previous co-op or internship experience is preferred, but not required. Students must have the ability to work full-time during the session. A minimum GPA of 3.2 is preferred. Local travel may be required.
Other required skills are:
Proficiency in MS Office Suite
Skills for word processing, spreadsheets, graphs and flowcharting
Attention to detail
Time management skills
Oral and written communication skills
Organizational skills
Students must be able to provide their own transportation to/from their work location. Students must be legally authorized to work in the United States and not require future sponsorship for employment visa status (e.g. H1-B status) now or in the future.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-New Jersey-Raritan
Other Locations:Add Location, North America-United States-New Jersey-Titusville
Organization: Janssen Research & Development, LLC. (6084)
Job: R&D
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Nearest Major Market: New Jersey
Job Segment: Neurology, Gastroenterology, Hematology, Immunology, Medical, Healthcare
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