Customer Job
Documentation Specialist - III (Senior)
Job ID: 23-01585
Job Title: Documentation Specialist - III (Senior)
Duration: 12+ months, 40 hrs / week
Location: Rahway, NJ 07065
Pay Rate: $40 - $ 44.52 Hourly, All-inclusive
Qualifications:
• Required: High School Diploma with 10 years’ experience in a related field and/or industry.
• Preferred: Bachelor’s degree and/or Certifications with 7 years’ experience in a related field and/or industry.
• Knowledge of scientific R&D documents within Animal Health or Pharmaceutical Industry is required.
• Must have in-depth knowledge of Regulatory, CMC, Clinical and/or Preclinical to be able to read, categorize and comprehend study related documentation.
• Expertise in Document Management Systems (Veeva Vault preferred) and/or other repositories.
• Expertise in Office-related software (Microsoft Excel, Microsoft Word, Adobe Acrobat, etc.).
• Knowledge and understanding of EPA, FDA GxP, FDA CFR 21 Part 11, OECD GLP, USDA, and VICH regulations and guidelines.
• This position requires excellent organizational skills, the ability to work independently and as part of a team with strong attention to detail and accuracy.
• Must learn quickly, have strong communication, organization, and writing skills with the ability to multi-task.
• Ability to apply strategic and analytical thinking to a Project.
• Demonstrated ability to focus and drive consistency in a fast-paced environment.
• Pre-Clinical, Clinical, CMC, Regulatory or QA experience. (should be reflected in the body of the resume)
• Veeva Vault a plus.
• NOTES: Must be able to follow directions. Position requires extensive attention to detail - should be reflected on resume - no misspellings or formatting errors. Should have previous archiving, data management and migration experience. Must work onsite a minimum of 3 days a week – (Tuesdays and Wednesdays are mandatory days, 3rd day can be Monday or Thursday).
Responsibilities:
• Migration of documents can include external Regulatory-related documents from SharePoint sites, network shares (i.e., shared drives), and electronic media.
• Upload (scan when needed) and classify documents to be made viewable in Alexx.
• Reclassify existing metadata on documents in Alexx from temporary storage to the production environment. Responsibilities:
• Must have in-depth knowledge of: Clinical, CMC, Drug Discovery, Preclinical, Quality (Formulation and Analytics), Regulatory, and/or Statistics documents to correctly identify and classify them.
• Review and identify document attributes and input corresponding metadata into Alexx.
• Request Study Numbers (Route of Administration, Pharmaceutical Form, Control, Test Species, GxP status, etc.), Products: (Product Family / Project Codes), and/or CRO Names using Alexx, when necessary.
• Contact personnel from the appropriate Business Unit to obtain information to correctly identify documents, as needed.
• Assure close working relationship with R&D stakeholders.
• Review documents and metadata for clarity and completeness prior to sending for approval.
• Assist with other Veeva Vault migration activities and other duties as assigned.
• This will satisfy the requirements according to EPA, FDA GxP, OECD GLP, USDA, and VICH regulations and guidelines to ensure document integrity.
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Intelliswift is committed to fair and equitable compensation practices. The range provided for this position is determined by various factors including, but not limited to, relevant work experience, skills, certifications, and location. Intelliswift offers medical insurance, dental insurance, vision insurance, supplemental life and AD&D insurance, and any other benefits per state law.
Equal Employment Opportunity Statement
Intelliswift celebrates a diverse and inclusive workforce. We offer equal employment opportunities to all applicants and employees. All qualified applicants will be considered regardless of race, color, sex, gender identity, gender expressions, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other protected basis under the law.
Americans with Disabilities Act (ADA)
If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact Intelliswift Human Resources Department
Other Employment Statements
Intelliswift participates in the E-Verify program.
For information on Intelliswift Software, Inc., visit our website at www.intelliswift.com.
Duration: 12+ months, 40 hrs / week
Location: Rahway, NJ 07065
Pay Rate: $40 - $ 44.52 Hourly, All-inclusive
Job Description:
Must work onsite a minimum of 3 days a week – (Tuesdays and Wednesdays are mandatory days, 3rd day can be Monday or Thursday).Qualifications:
• Required: High School Diploma with 10 years’ experience in a related field and/or industry.
• Preferred: Bachelor’s degree and/or Certifications with 7 years’ experience in a related field and/or industry.
• Knowledge of scientific R&D documents within Animal Health or Pharmaceutical Industry is required.
• Must have in-depth knowledge of Regulatory, CMC, Clinical and/or Preclinical to be able to read, categorize and comprehend study related documentation.
• Expertise in Document Management Systems (Veeva Vault preferred) and/or other repositories.
• Expertise in Office-related software (Microsoft Excel, Microsoft Word, Adobe Acrobat, etc.).
• Knowledge and understanding of EPA, FDA GxP, FDA CFR 21 Part 11, OECD GLP, USDA, and VICH regulations and guidelines.
• This position requires excellent organizational skills, the ability to work independently and as part of a team with strong attention to detail and accuracy.
• Must learn quickly, have strong communication, organization, and writing skills with the ability to multi-task.
• Ability to apply strategic and analytical thinking to a Project.
• Demonstrated ability to focus and drive consistency in a fast-paced environment.
• Pre-Clinical, Clinical, CMC, Regulatory or QA experience. (should be reflected in the body of the resume)
• Veeva Vault a plus.
• NOTES: Must be able to follow directions. Position requires extensive attention to detail - should be reflected on resume - no misspellings or formatting errors. Should have previous archiving, data management and migration experience. Must work onsite a minimum of 3 days a week – (Tuesdays and Wednesdays are mandatory days, 3rd day can be Monday or Thursday).
Responsibilities:
• Migration of documents can include external Regulatory-related documents from SharePoint sites, network shares (i.e., shared drives), and electronic media.
• Upload (scan when needed) and classify documents to be made viewable in Alexx.
• Reclassify existing metadata on documents in Alexx from temporary storage to the production environment. Responsibilities:
• Must have in-depth knowledge of: Clinical, CMC, Drug Discovery, Preclinical, Quality (Formulation and Analytics), Regulatory, and/or Statistics documents to correctly identify and classify them.
• Review and identify document attributes and input corresponding metadata into Alexx.
• Request Study Numbers (Route of Administration, Pharmaceutical Form, Control, Test Species, GxP status, etc.), Products: (Product Family / Project Codes), and/or CRO Names using Alexx, when necessary.
• Contact personnel from the appropriate Business Unit to obtain information to correctly identify documents, as needed.
• Assure close working relationship with R&D stakeholders.
• Review documents and metadata for clarity and completeness prior to sending for approval.
• Assist with other Veeva Vault migration activities and other duties as assigned.
• This will satisfy the requirements according to EPA, FDA GxP, OECD GLP, USDA, and VICH regulations and guidelines to ensure document integrity.
-----------------------------------------------------------------------------------------------------------------------------------------------------------
Intelliswift is committed to fair and equitable compensation practices. The range provided for this position is determined by various factors including, but not limited to, relevant work experience, skills, certifications, and location. Intelliswift offers medical insurance, dental insurance, vision insurance, supplemental life and AD&D insurance, and any other benefits per state law.
Equal Employment Opportunity Statement
Intelliswift celebrates a diverse and inclusive workforce. We offer equal employment opportunities to all applicants and employees. All qualified applicants will be considered regardless of race, color, sex, gender identity, gender expressions, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other protected basis under the law.
Americans with Disabilities Act (ADA)
If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact Intelliswift Human Resources Department
Other Employment Statements
Intelliswift participates in the E-Verify program.
For information on Intelliswift Software, Inc., visit our website at www.intelliswift.com.
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