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Job Description Clinical Supplies Manager needs Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background Clinical Supplies Manager requires: CDMO management, Master Batch Records (MBR), Master Packaging Work Orders (MPWO), Interactive Response Technology (IRT), Interactive Web Response System (IWRS), Excel, Microsoft Office, ARIBA, Clinical Trial Material (CTM) inventory forecasting, regulatory submissions (IND, Annual reports, amendments), SOP writing, SOP review, study protocols, pharmaceutical stability protocols, GMP batch record development/review/approval, GCP, cGMP, supply chain management, budget management, financial tracking, RFP preparationve, Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background. Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports. Expert technical skills, good organization skills, ability to follow directions, and good communication skills. Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data. Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities. Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products Knowledge of GMP batch record development, review, and approval process Demonstrated understanding of the entire supply chain and associated cost drivers Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system. Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus. Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus. Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus. Ability to understand, maintain, and demonstrate troubleshooting on vendors IRT/IVRS system, a plus. Clinical Supplies Manager duties o Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies. o Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents. o Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product. o Assist and support the management of clinical supply inventories using Interactive Response Technology. o Expected to prepare data tables when needed for data interpretation. o Assist with documentation and process internal and external change controls. o Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc. o Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking. o Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global). o Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits. o Assist and support Clinical Operations on document reviews related to o o Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it. o Prepare requests for proposals for activities in support of clinical supply projects. o Review CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations. o Assist and prepare CDMO Vendor Comparison slides and assist in the selection of an appropriate CDMO based on technical ability, cost, and ability to deliver on time. o Provide technical support for vendors IRT/IWRS system in support of SK clinical studies. o Utilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed. o Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments. o Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols. o Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc. o Assist and prepare Excel tables when needed. o Assist in the maintenance of SOPs related to reflecting current clinical supply activities. o Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors. o Financial Management o Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects. o Prepare, maintain, and monitor project budgets for the CMC Team o Review and process clinical supply CMO invoices for project activities. o Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested. o Participate in project budgeting and forecasting process for the CMC Teams annual project o

Job Description Clinical Supplies Manager Paramus, NJ Clinical Supplies Manager Paramus, NJ Experience level: Mid-senior Experience required: 8 Years Education level: Bachelors degree Job function: Management Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No SUMMARY OF POSITION: Assist and support the Associate Director in managing Contract Development and Research Organizations (CDMO) in the areas of Clinical Supplies. Review master batch records (MBR), Master Packaging Work Orders (MPWO), and clinical related supplies-related documents. Assist and support the review of packaging, labeling, storage, logistics, and distribution documentation of the investigational product. Assist and support the management of clinical supply inventories using Interactive Response Technology. Expected to prepare data tables when needed for data interpretation. Assist with documentation and process internal and external change controls. Assist and support clinical supply activities for investigational products, such as import and export, customs clearance, DEA Controlled Drug experiences, etc. Manage and processing of CMC Team project invoices and internal project budget requests (ARIBA), and monitoring of project financial tracking. Assist and support Regulatory Affairs (RA) to provide any documents for their submissions (US and Global). Assist and support the Quality Assurance Unit (QAU) regarding the review of investigations and conduct vendors and internal audits. Assist and support Clinical Operations on document reviews related to KEY RESPONSIBILITIES: Technical Management Assist collaborated team to prepare clinical supplies request forms for new and existing studies when its need it. Prepare requests for proposals for activities in support of clinical supply projects. Review CDMO Project proposals and provide feedback to the Associate Director before selecting a specific vendor, review and audit slides, tables, and budget calculations. Assist and prepare CDMO Vendor Comparison slides and assist in the selection of an appropriate CDMO based on technical ability, cost, and ability to deliver on time. Provide technical support for vendors IRT/IWRS system in support of SK clinical studies. Utilize inventory forecasting software to ensure an adequate amount of CTMs is available to supply clinical sites when needed. Assist and support in writing and preparation of regulatory submission documents: drug product and drug substance sections in IND, Annual reports, and Informational amendments. Assist and support in writing and preparation of SOPs and interpreting and reviewing SOPs and study protocols. Review manufacturing, packaging, and labeling Master and Executed Packaging Work Orders/Batch Records (MBR/EBR, Packaging Labeling Approval Forms (PLAF), Labeling Approval Forms (LAF), etc. Assist and prepare Excel tables when needed. Assist in the maintenance of SOPs related to reflecting current clinical supply activities. Assist and support Investigational Product Returns and Reconciliation at the end of the studies and collect all necessary documentation from vendors. Financial Management Prepare Ariba process for internal budget approval of new/ongoing CMC Team projects. Prepare, maintain, and monitor project budgets for the CMC Team Review and process clinical supply CMO invoices for project activities. Prepare and assist the FP&A team on project-specific spending and accrual monthly and quarterly basis, if requested. Participate in project budgeting and forecasting process for the CMC Teams annual project budget management activities. QUALIFICATIONS: Bachelors degree in chemistry (preferred analytical) and up to 5-8 years of experience working in an analytical laboratory background. Ability to read, analyze, and interpret basic scientific protocols, reports, and technical journals. Also, should be able to interpret financial reports. Expert technical skills, good organization skills, ability to follow directions, and good communication skills. Computer aptitude is a plus, especially proficiency with Microsoft Office, and in particular use of Excel and the ability to plot data. Understand protocols, write SOPs, and have technical knowledge of packaging and labeling activities. Knowledge of pharmaceutical stability protocols, assessment of expiration dating for investigational drug products Knowledge of GMP batch record development, review, and approval process Demonstrated understanding of the entire supply chain and associated cost drivers Ability to execute the Clinical Supply portion of User Acceptance Testing (UAT) for the IRT system. Knowledge of GCP and global cGMP regulations, (knowledge of EU GMP QP regulations is preferred), a plus. Knowledge of warehousing, distribution (including cold chain distribution), and logistics, a plus. Ability to review, analyze, and interpret the IVR/IRT reports and specification requirements, a plus. Ability to understand, maintain, and demonstrate troubleshooting on vendors IRT/IVRS system, a plus.

Job Description We are seeking an Import Data Coordinator to join our team! Job Summary: ISF Data Processor This role involves Import data entry of 10 ISF data elements on incoming shipments from clients and vendors. The Import Security Filing elements include: Product information, Country of Origin, Importer of record, and IRS/Bond data. Responsible for sending emails for missing information, transmission to US Customs for approval, Excel knowledge required. This job is within Internal Operations, customer/client success and clerical data entry to streamline the import process. Core Clerical Responsibilities for ISF Processor: • Receive an Import Security File from our Importer or vendor involved in the filing., • Keep electronic copy of all emails/forms in our operating system, • Track the Import Security Filing to make sure it has not already been entered, • If new, create a new filing in the system and obtain approval, • Sending of all emails requesting missing information. These emails must be monitored daily for a response., • If a response is not received by 12 noon the next day a reminder email should be sent requesting the missing details, this should be done daily until received, • Keep track of Import Security Files that do not have an S1 (approved filing) at time of ETD Other clerical responsibilities: • Maintaining customer reports (excel) to ensure an ISF is filed for every shipment, • Obtaining ISF bonds for clients who do not have a continuous bond in place

Experience: A minimum of one (1) year of specialized experience equivalent to at least the next lower grade level that includes: * Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Officers are eligible to select from

Experience: A minimum of one (1) year of specialized experience equivalent to at least the next lower grade level that includes: * Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Age Restriction: Must be referred be

Experience: A minimum of one (1) year of specialized experience equivalent to at least the next lower grade level that includes: * Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Select "Customs and Border Protectio

Border Patrol Academy in Artesia, NM for 6 months of instruction in immigration law, firearms, defensive tactics, Spanish, and more. Select "Border Patrol Agent" and complete the pre-screening questions. You may qualify for these higher-graded Border Patrol Agent (BPA) opportunities if you have curr

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Youll receive a link to the official job posting on USAJOBS to complete your application. Customs and Border Protection (CBP) offers those interested in a career in law

Enforcing customs, immigration, and agriculture laws and regulations. Check the GS-9 CBPO listing on USAJOBS. Must be referred before turning 40 (some exceptions apply for federal or veteran candidates).

Experience: A minimum of one (1) year of specialized experience equivalent to at least the next lower grade level that includes: * Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Customs and Border Protection (CBP)

Air and Marine Operations (AMO), a component of U.S. Customs and Border Protection (CBP), offers EXPERIENCED PILOTS interested in law enforcement an exceptional opportunity to work with an elite team of highly trained professionals whose camaraderie, pride, and purpose are hallmarks of their daily mission protecting America. If you're looking for an exciting and rewarding career with great pay, benefits, and job stability, now is the time to make your move! Get an insider’s point-of-view about the challenges and rewards on Thursday, October 23rd at 2 PM ET in a live webinar presentation by AMO Agents. Federal civil service is a great place to build a career in law enforcement–join the call and learn about the qualifications you’ll need to get your career started. Click on the Apply button on this site to register for the webinar through our Talent Network. Complete the short form and select Air and Marine Operations (Air Interdiction Agent) from the Positions of Interest dropdown menu. You’ll receive the webinar link approximately two days before the event. Possible duty locations by region:Southeast Region: (to include but not limited to the following locations) Homestead, FL and the Caribbean Air and Marine Branch (CAMB): Aguadilla, PRSouthwest Region: (to include but not limited to the following locations) Tucson and Yuma, AZ; San Diego, CA; El Paso, Laredo, and McAllen, TXNational Air Security Operation Center (NASOC) Unmanned Aircraft System (UAS) Locations: (to include but not limited to the following locations) Sierra Vista, AZ; San Angelo, TX Not interested in law enforcement? Go ahead and register for this webinar and select one of the many other career opportunities so CBP can stay in touch with news of future career events and position openings.

Combination of Experience and Education: A combination of specialized work experience equivalent to the next lower grade level AND graduate level education from an accredited college or university. Locations offered are based on operational and mission requirements and critical agency hiring

Enforcing customs, immigration, and agriculture laws and regulations. Check the GS-9 CBPO listing on USAJOBS. Must be referred before turning 40 (some exceptions apply for federal or veteran candidates).

Experience: A minimum of one (1) year of specialized experience equivalent to at least the next lower grade level that includes: Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Candidates must be referred for sele

Experience: A minimum of one (1) year of specialized experience equivalent to at least the next lower grade level that includes: * Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Officers are eligible to select from

Experience: A minimum of one (1) year of specialized experience equivalent to at least the next lower grade level that includes: * Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Customs and Border Protection (CBP)

Experience: A minimum of one (1) year of specialized experience equivalent to at least the next lower grade level that includes: * Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Select "Customs and Border Protectio

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of highly trained profe

Must be referred before turning 40 (some exceptions apply for federal or veteran candidates). Choose Customs and Border Protection Officer as your position of interest. You will then be directed to the official job posting on USAJOBS to submit your application.

Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of highly trained professionals whose camaraderie, pride, and purpose are hallmarks of their daily mission of protecting America. As a Customs and Border P

Must have lived primarily in the U. Must be referred before turning 40 (exceptions for federal or veteran law enforcement). Border Patrol (USBP) offers a career with camaraderie, pride, purpose, and the mission of protecting America.

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Enforcing customs, immigration, and agriculture laws and regulations. Officers are eligible to select from an array of federal employment benefits that include health,

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of highly trained profe

You will then be directed to the official job posting on USAJOBS to submit your application. Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of highly trained professionals whose camaraderie, pride, and

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Enforcing customs, immigration, and agriculture laws and regulations. Officers are eligible to select from an array of federal employment benefits that include health,

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. As a Customs and Border Protection Officer (CBPO), you will be part of our 60,000+ workforce that strives to protect the American people by safeguarding our borders, de

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Youll receive a link to the official job posting on USAJOBS to complete your application. Customs and Border Protection (CBP) offers those interested in a career in law

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of highly trained profe

Apprehending violators using surveillance and detection tech. Must be referred before turning 40 (exceptions for federal or veteran law enforcement). Patrolling using vehicles, horses, boats, ATVs, snowmobiles, or motorcycles.

Apprehending undocumented individuals or smugglers using covert surveillance and infrared scopes. Patrolling using vehicles, horses, boats, ATVs, snowmobiles, or motorcycles. Apprehending or restraining suspects in violation of law.

Choose Customs and Border Protection Officer as your position of interest. You will then be directed to the official job posting on USAJOBS to submit your application. Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with a

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of highly trained profe

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of highly trained profe

Patrolling using vehicles, horses, boats, ATVs, snowmobiles, or motorcycles. Apprehending or restraining suspects in violation of law. Using intelligence to monitor criminal threats and operations.

Enforcing customs, immigration, and agriculture laws and regulations. Check the GS-9 CBPO listing on USAJOBS. Must be referred before turning 40 (some exceptions apply for federal or veteran candidates).

Must have lived primarily in the U. Must be referred before turning 40 (exceptions for federal or veteran law enforcement). Border Patrol (USBP) offers a career with camaraderie, pride, purpose, and the mission of protecting America.

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Select "Customs and Border Protection Officer" as your Position of Interest. Youll receive a link to the official job posting on USAJOBS to complete your application.

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Must be referred before your 40th birthday (some exceptions apply). Select "Customs and Border Protection Officer" as your Position of Interest.

Apprehending undocumented individuals or smugglers using covert surveillance and infrared scopes. Using firearms, writing reports, serving warrants, and gathering case evidence. Using intelligence to monitor criminal threats and operations.

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Youll receive a link to the official job posting on USAJOBS to complete your application. Customs and Border Protection (CBP) offers those interested in a career in law

Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of highly trained professionals whose camaraderie, pride, and purpose are hallmarks of their daily mission of protecting America. As a Customs and Border P

As a Customs and Border Protection Officer (CBPO), you will be part of our 60,000+ workforce that strives to protect the American people by safeguarding our borders, deterring illicit activity, and enhancing the nations economic prosperity. Enforcing customs, immigration, and agriculture laws and re

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Enforcing customs, immigration, and agriculture laws and regulations. Officers are eligible to select from an array of federal employment benefits that include health,

Must have lived primarily in the U. Must be referred before turning 40 (exceptions for federal or veteran law enforcement). Border Patrol (USBP) offers a career with camaraderie, pride, purpose, and the mission of protecting America.

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Youll receive a link to the official job posting on USAJOBS to complete your application. Customs and Border Protection (CBP) offers those interested in a career in law

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Youll receive a link to the official job posting on USAJOBS to complete your application. Customs and Border Protection (CBP) offers those interested in a career in law

As a Customs and Border Protection Officer (CBPO), you will be part of our 60,000+ workforce that strives to protect the American people by safeguarding our borders, deterring illicit activity, and enhancing the nations economic prosperity. Enforcing customs, immigration, and agriculture laws and re

Detaining suspected violators of federal, state, or local laws and/or arresting violators using the proper law enforcement methods. Must be referred before your 40th birthday (some exceptions apply). Select "Customs and Border Protection Officer" as your Position of Interest.