Job Description POSITION SUMMARY Under the regular supervision of the Pharmacy Director, facilities purchasing of supplies, drugs, equipment, monitors compliance to financial and operational targets. Performs Pharmacy Tech duties as needed. Provides administrative assistance to the Director of Pharmacy. Prepares minutes, agendas and documents for Pharmacy & Therapeutics Committee, Medication Safety, departmental staff meetings and other meetings as assigned. Coordinates payroll and scheduling of employees. The following job description covers the most significant duties performed, but does not exclude other work assignments not mentioned PRIMARY RESPONSIBILITIES Principal Duties: Performs Pharmacy Buyer activities: Processes pharmaceutical returns to wholesaler or vendor. Verifies receipt of credit for returns and maintains records. Determines the need and urgency for out of stock pharmaceuticals from primary vendor or wholesaler. Critical shortages are reported to the pharmacy supervisor or Director. Reconciles vendor invoices with merchandise received, insures correct price, department purchase order number and reports any discrepancies to vendor and the Director of Pharmacy daily. Monitors the quality control storage of pharmaceuticals and sets appropriate PAR levels under the supervision of the Pharmacy Supervisor or Director. Coordinates all drug recalls, determines levels of recalled drugs in stock and maintains records in accordance with federal law. Informs Director of results. Separates expired pharmaceuticals from regular inventory and coordinates processing with selected vendor monthly or as assigned. Responsible for completing the return of borrowed items within 3 working days of receipt and maintaining records. Creates and submits 340B, GPO and WAC purchasing orders based on accumulations for virtual sites or par levels for physical inventory sites. Manages purchasing, receiving and inventory control processes. Monitors product min/max levels to effectively balance product availability and cost-efficient inventory control. Monitors split billing software to ensure replenishment accuracy Uploads manual invoices into the split billing software Performs routine NDC to CDM mapping Assist the 340B Manager/Analyst with compliance audits and issue resolution. Archives purchase history information to make it available to auditors when needed. Coordinates Departmental administrative activities: Maintains Department Administration and Monthly Billing Coordinates the purchasing and maintenance of inventory of office supplies. Coordinates departmental, interdepartmental and Pharmaceutical Representative meetings for the Director. Collaborates with the clinical pharmacist and Director to arrange monthly departmental continuing education lectures. Recorder for all departmental meetings and maintains and distributes minutes. Provides computer and office support for all departmental correspondence related to budget review, clinical initiatives, committee meetings, newsletter production and daily operations. Develops cost data documents as required. Assists the Director with updating and maintaining department and hospital policy and procedure manuals on an ongoing basis. Manages agency staff files and updates in a timely and confidential manner in accordance with JCAHO and Hospital standards. Responsible for maintaining all regulatory licenses and permits for the department. Renewals must be done before due dates. Maintains operations and service for all office related equipment. Provides daily pick-up and distribution of department incoming and outgoing mail. Manages all direct purchase account files. Assists with the completion of the monthly interdepartmental billing and report preparation. Serves as support for professional and technical staff as needed. Assists Director in maintaining proper medication paperwork, forms, files etc., to meet JCAHO, OSHA, State and Federal regulations and Board of Pharmacy compliance. Prepares minutes, agendas, and documents for various committees, workgroups and departments. Performs duties of a Pharmacy Technician II and Assists in Maintaining Purchasing and Inventory Functions for Pharmaceuticals. Performs all the duties and functions of a Pharmacy Technician II as needed. Customer Service: 1. Greets customers in courteous, friendly, respectful and professional manner at all times, including maintaining eye contact when appropriate. 2. Follows communication protocols to both internal and external customers, including introducing him/herself with job title and experience, asking open ended questions, such as "How may I be of help to you?" using the customer's name as soon as it is learned. 3. Responds promptly and appropriately to customer questions/concerns/complaints and attempts immediate resolution. 4. Keeps customer's information confidential, including public places such as elevators or the cafeteria. 5. Provides assistance and offers help immediately, including finding someone else to meet the request, if unable to do so him/herself. Introduce other staff to customers when a hand-off occurs and explain that the person will provide excellent service. 6. Demonstrates commitment to excellent service recovery when a customer's expectations have not been met. Commitment to Co-Workers: 1. Offers assistance to colleagues and other departments when needed. 2. Takes responsibility for solving problems regardless of origin; completes assignments, and respects deadlines. 3. Resolves conflict directly with colleagues and seeks assistance from others if the issue cannot be resolved. Refrains from criticism in public. 4. Mindful and respectful of others' time and schedules. Attends meetings on time and communicates any absences. 5. Provides co-workers with a status report for continuity of workflow when planning to be out of the office, off the unit, or away from the department Communication Etiquette: 1. Respectful, courteous and professional in all forms of communication and follows facility's service communication protocol in all interactions. 2. Refrains from use of personal cell phone in patient care areas and keeps usage to a minimum at all other times while on duty. 3. Does not text or use e-mail during meetings (except for exigent or emergency situations). 4. Limits use of business cell phone during meetings (remain on vibrate and/or calls go to voicemail). 5. Makes every effort to answer telephone calls within three rings, introducing him/herself, department and title (if appropriate). Asks permission before placing the caller on hold or using the speakerphone. If caller is transferred, gives the caller the extension number of the person he or she is being transferred to. Offers further assistance to the caller upon completing the conversation. 6. Maintains an appropriate voicemail message and when away from the office has an out-of-office email message that is brief, current, and includes name and department and offers the caller options if possible. 7. Returns email and voicemail messages promptly but no later than within one business day (24 hours). 8. Always mindful of voice and language in public. Self Management: 1. Reports to work appropriately groomed and in compliance with the Hospital's dress code. Wears identification badge at all times at chest level and facing outwards so identification is clearly visible. 2. Complete all assignments within deadlines or negotiates alternative actions and time frames in order to achieve desired outcomes. 3. Completes mandatory, annual education and competency requirements. 4. Follows UM CAP safety, infection control and employee health standards. 5. Demonstrates responsibility for personal growth, development and professional knowledge and competency. 6. Adhere to all UM CAP and department policies and procedures, including Code of Conduct and professional behavior standards. Does not exceed Hospital guidelines in reference to attendance, punctuality, and use of sick and unplanned absences. Provides notification of absences, lateness and vacation requests according to department guidelines. Respects length of time for lunch and break times. 7. Reviews, signs, and adheres to UM CAP and/or departmental confidentiality statement.
03/06/2024
Full time
Job Description POSITION SUMMARY Under the regular supervision of the Pharmacy Director, facilities purchasing of supplies, drugs, equipment, monitors compliance to financial and operational targets. Performs Pharmacy Tech duties as needed. Provides administrative assistance to the Director of Pharmacy. Prepares minutes, agendas and documents for Pharmacy & Therapeutics Committee, Medication Safety, departmental staff meetings and other meetings as assigned. Coordinates payroll and scheduling of employees. The following job description covers the most significant duties performed, but does not exclude other work assignments not mentioned PRIMARY RESPONSIBILITIES Principal Duties: Performs Pharmacy Buyer activities: Processes pharmaceutical returns to wholesaler or vendor. Verifies receipt of credit for returns and maintains records. Determines the need and urgency for out of stock pharmaceuticals from primary vendor or wholesaler. Critical shortages are reported to the pharmacy supervisor or Director. Reconciles vendor invoices with merchandise received, insures correct price, department purchase order number and reports any discrepancies to vendor and the Director of Pharmacy daily. Monitors the quality control storage of pharmaceuticals and sets appropriate PAR levels under the supervision of the Pharmacy Supervisor or Director. Coordinates all drug recalls, determines levels of recalled drugs in stock and maintains records in accordance with federal law. Informs Director of results. Separates expired pharmaceuticals from regular inventory and coordinates processing with selected vendor monthly or as assigned. Responsible for completing the return of borrowed items within 3 working days of receipt and maintaining records. Creates and submits 340B, GPO and WAC purchasing orders based on accumulations for virtual sites or par levels for physical inventory sites. Manages purchasing, receiving and inventory control processes. Monitors product min/max levels to effectively balance product availability and cost-efficient inventory control. Monitors split billing software to ensure replenishment accuracy Uploads manual invoices into the split billing software Performs routine NDC to CDM mapping Assist the 340B Manager/Analyst with compliance audits and issue resolution. Archives purchase history information to make it available to auditors when needed. Coordinates Departmental administrative activities: Maintains Department Administration and Monthly Billing Coordinates the purchasing and maintenance of inventory of office supplies. Coordinates departmental, interdepartmental and Pharmaceutical Representative meetings for the Director. Collaborates with the clinical pharmacist and Director to arrange monthly departmental continuing education lectures. Recorder for all departmental meetings and maintains and distributes minutes. Provides computer and office support for all departmental correspondence related to budget review, clinical initiatives, committee meetings, newsletter production and daily operations. Develops cost data documents as required. Assists the Director with updating and maintaining department and hospital policy and procedure manuals on an ongoing basis. Manages agency staff files and updates in a timely and confidential manner in accordance with JCAHO and Hospital standards. Responsible for maintaining all regulatory licenses and permits for the department. Renewals must be done before due dates. Maintains operations and service for all office related equipment. Provides daily pick-up and distribution of department incoming and outgoing mail. Manages all direct purchase account files. Assists with the completion of the monthly interdepartmental billing and report preparation. Serves as support for professional and technical staff as needed. Assists Director in maintaining proper medication paperwork, forms, files etc., to meet JCAHO, OSHA, State and Federal regulations and Board of Pharmacy compliance. Prepares minutes, agendas, and documents for various committees, workgroups and departments. Performs duties of a Pharmacy Technician II and Assists in Maintaining Purchasing and Inventory Functions for Pharmaceuticals. Performs all the duties and functions of a Pharmacy Technician II as needed. Customer Service: 1. Greets customers in courteous, friendly, respectful and professional manner at all times, including maintaining eye contact when appropriate. 2. Follows communication protocols to both internal and external customers, including introducing him/herself with job title and experience, asking open ended questions, such as "How may I be of help to you?" using the customer's name as soon as it is learned. 3. Responds promptly and appropriately to customer questions/concerns/complaints and attempts immediate resolution. 4. Keeps customer's information confidential, including public places such as elevators or the cafeteria. 5. Provides assistance and offers help immediately, including finding someone else to meet the request, if unable to do so him/herself. Introduce other staff to customers when a hand-off occurs and explain that the person will provide excellent service. 6. Demonstrates commitment to excellent service recovery when a customer's expectations have not been met. Commitment to Co-Workers: 1. Offers assistance to colleagues and other departments when needed. 2. Takes responsibility for solving problems regardless of origin; completes assignments, and respects deadlines. 3. Resolves conflict directly with colleagues and seeks assistance from others if the issue cannot be resolved. Refrains from criticism in public. 4. Mindful and respectful of others' time and schedules. Attends meetings on time and communicates any absences. 5. Provides co-workers with a status report for continuity of workflow when planning to be out of the office, off the unit, or away from the department Communication Etiquette: 1. Respectful, courteous and professional in all forms of communication and follows facility's service communication protocol in all interactions. 2. Refrains from use of personal cell phone in patient care areas and keeps usage to a minimum at all other times while on duty. 3. Does not text or use e-mail during meetings (except for exigent or emergency situations). 4. Limits use of business cell phone during meetings (remain on vibrate and/or calls go to voicemail). 5. Makes every effort to answer telephone calls within three rings, introducing him/herself, department and title (if appropriate). Asks permission before placing the caller on hold or using the speakerphone. If caller is transferred, gives the caller the extension number of the person he or she is being transferred to. Offers further assistance to the caller upon completing the conversation. 6. Maintains an appropriate voicemail message and when away from the office has an out-of-office email message that is brief, current, and includes name and department and offers the caller options if possible. 7. Returns email and voicemail messages promptly but no later than within one business day (24 hours). 8. Always mindful of voice and language in public. Self Management: 1. Reports to work appropriately groomed and in compliance with the Hospital's dress code. Wears identification badge at all times at chest level and facing outwards so identification is clearly visible. 2. Complete all assignments within deadlines or negotiates alternative actions and time frames in order to achieve desired outcomes. 3. Completes mandatory, annual education and competency requirements. 4. Follows UM CAP safety, infection control and employee health standards. 5. Demonstrates responsibility for personal growth, development and professional knowledge and competency. 6. Adhere to all UM CAP and department policies and procedures, including Code of Conduct and professional behavior standards. Does not exceed Hospital guidelines in reference to attendance, punctuality, and use of sick and unplanned absences. Provides notification of absences, lateness and vacation requests according to department guidelines. Respects length of time for lunch and break times. 7. Reviews, signs, and adheres to UM CAP and/or departmental confidentiality statement.
Data Center Warehouse Coordinators We have multiple positions open in Ashburn, VA / Somerset NJ / Piscataway NJ All FT with various shifts some include Saturday The Quick Group is a highly specialized, global shipping and logistics provider focused on designing customized delivery solutions for time and temperature sensitive, mission-critical and life saving needs across a wide range of industries. For more than 36 years, Quick has been providing the world's leading companies with the industry's most reliable and innovative global logistics solutions. Our various divisions are comprised of highly skilled and experienced industry specialists, offering in-depth expertise to each of the distinct markets we serve, such as aviation, life science, pharmaceutical, biotech, medical, financial, technology and entertainment. KNOWLEDGEABLE. PASSIONATE. COMMITTED. Quick brings together the most knowledgeable and passionate logistics experts. Our worldwide team is committed to providing our clients customized logistics solutions, unparalleled service and the optimal customer experience. Job Responsibilities: Receive shipments of equipment (including but not limited to routers, services, spare parts etc.) and inventory them into the QIC inventory system and other agreed upon Morgan Stanley internal systems Pack equipment onsite and prepare outbound shipments for transport Work in Qtrak operating system using QIC's inventory system Maintain all asset inventory records for the site and conduct regular reporting Maintain chain of custody of assets and diligently manage inventory of Quick's exclusively controlled assets and storage spaces Ensure secure staging areas per QIC SOP standards Prepare assets for installation into production including but not limited to the following activities: unboxing, asset tagging, waste packaging removal, and aggregating required install components Receive assets removed from production spaces and process for storage, disposal, shipment or redeployment Ensure assets for disposal are inventoried and chain of custody procedures are followed locally to handoff of approved Morgan Stanley disposal vendor In some cases, operation of onsite hard disk drive shredder may be required Be able to take direction and be flexible in other tasks within the facility related to equipment relocation and transports Be reliable and able to work the hours needed to support the datacenter for the hours required and noted in the SOW Follow QIC's SOP which will include the above information and specific operating details Work with Morgan Stanley local personnel for other tasks when there is "down time" Additional tasks within the scope of this statement of work will be added to the job description upon review with Morgan Stanley personnel Scanning inbound freight into the WMS database system and verifying accuracy Placing inbound freight once scanned into storeroom Identify any damages to shipments when received and follow escalation procedures immediately Quick resources to follow packing procedures noted in the "packing procedures for IT equipment" for all loose equipment Follow all security protocols in this SOW related to storing and securing datacenter assets Benefits Medical, Dental, Life, AD&D, STD & LTD Prescription Drug plan 401k Join Us! If you are looking for a challenging position with an innovative and expanding global organization
09/25/2021
Full time
Data Center Warehouse Coordinators We have multiple positions open in Ashburn, VA / Somerset NJ / Piscataway NJ All FT with various shifts some include Saturday The Quick Group is a highly specialized, global shipping and logistics provider focused on designing customized delivery solutions for time and temperature sensitive, mission-critical and life saving needs across a wide range of industries. For more than 36 years, Quick has been providing the world's leading companies with the industry's most reliable and innovative global logistics solutions. Our various divisions are comprised of highly skilled and experienced industry specialists, offering in-depth expertise to each of the distinct markets we serve, such as aviation, life science, pharmaceutical, biotech, medical, financial, technology and entertainment. KNOWLEDGEABLE. PASSIONATE. COMMITTED. Quick brings together the most knowledgeable and passionate logistics experts. Our worldwide team is committed to providing our clients customized logistics solutions, unparalleled service and the optimal customer experience. Job Responsibilities: Receive shipments of equipment (including but not limited to routers, services, spare parts etc.) and inventory them into the QIC inventory system and other agreed upon Morgan Stanley internal systems Pack equipment onsite and prepare outbound shipments for transport Work in Qtrak operating system using QIC's inventory system Maintain all asset inventory records for the site and conduct regular reporting Maintain chain of custody of assets and diligently manage inventory of Quick's exclusively controlled assets and storage spaces Ensure secure staging areas per QIC SOP standards Prepare assets for installation into production including but not limited to the following activities: unboxing, asset tagging, waste packaging removal, and aggregating required install components Receive assets removed from production spaces and process for storage, disposal, shipment or redeployment Ensure assets for disposal are inventoried and chain of custody procedures are followed locally to handoff of approved Morgan Stanley disposal vendor In some cases, operation of onsite hard disk drive shredder may be required Be able to take direction and be flexible in other tasks within the facility related to equipment relocation and transports Be reliable and able to work the hours needed to support the datacenter for the hours required and noted in the SOW Follow QIC's SOP which will include the above information and specific operating details Work with Morgan Stanley local personnel for other tasks when there is "down time" Additional tasks within the scope of this statement of work will be added to the job description upon review with Morgan Stanley personnel Scanning inbound freight into the WMS database system and verifying accuracy Placing inbound freight once scanned into storeroom Identify any damages to shipments when received and follow escalation procedures immediately Quick resources to follow packing procedures noted in the "packing procedures for IT equipment" for all loose equipment Follow all security protocols in this SOW related to storing and securing datacenter assets Benefits Medical, Dental, Life, AD&D, STD & LTD Prescription Drug plan 401k Join Us! If you are looking for a challenging position with an innovative and expanding global organization
Why Patients Need You Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action. What You Will Achieve Working with Pfizer's dynamic engineering team, the Training and Compliance Coordinator is primarily responsible for ensuring training and compliance within the Engineering Maintenance and Utilities group, including reviewing, evaluating, and working with the team to resolve potential compliance issues within the organization's manufacturing facilities. The individual in this role will ensure that employees are adequately trained and systems are compliant with the rules and regulations of Pfizer as well as industry regulatory agencies. The Training and Compliance Coordinator will be responsible for monitoring, reporting, and aiding in remediating any compliance issues as well as tracking completion of compliance related commitments and manufacturing investigation reports. The Training and Compliance Coordinator will also be responsible for coordinating with Subject Matter Experts (SME's) and other departments during site audits. The Training and Compliance Coordinator will also be responsible for reviewing current group training curricula's, develop role specific modules to minimize unnecessary trainings and conducting training as needed. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Develop and conduct compliance reviews, assessments, analyses, and other business engagement activities within established frameworks to identify, track, and report on the remediation of compliance gaps Create, maintain, and monitor compliance systems to ensure effectiveness in all manufacturing areas Develop and prepare meaningful reporting and tracking of compliance activities to enable effective communication to senior management and all facilities Assist in the ongoing development and enhancement of the compliance program Keep current on emerging compliance issues and trends Assist with and oversee compliance training needs in all departments and areas in Engineering. Supervise the submission of responses to regulatory agencies Develop and maintain relationships with quality organizations. Create, maintain, improve, and track the Company's standard operating procedures and policies in collaboration with Engineering Lead investigation and resolution into compliance concerns Create and manage effective action plans in response to audit discoveries and compliance violations. Assess company operations to determine compliance risk. Ensure all employees are educated on the latest regulations and processes Qualifications Must-Have Bachelor's Degree 5+ years of demonstrated experience in product development, manufacturing science and technology, within the pharmaceutical industry Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, design control The ideal candidate will be well organized, detailed oriented, and have strong problem-solving skills work comfortably under pressure, and deliver on tight deadlines. The Training and Compliance Coordinator should be confident, professional, and self-motivated with a keen interest in the ethical, legal, and regulatory requirements of a business. Top candidates will have outstanding presentation and report writing skills, with the ability to work on their own initiative and as part of a team. Ability to follow written procedures and monitor others for adherence to written procedures. Ability to create or update written procedures with site operations personnel Team player with strong interpersonal skills. Open-minded self-starter with the ability to adapt and problem solve, as well manage multiple tasks concurrently. Nice-to-Have Master's degree Relevant pharmaceutical experience Demonstrated ability to train and coach others Experience with Six Sigma or other operational excellence programs In-depth knowledge of drug substance/drug substance intermediate manufacturing technology PHYSICAL/MENTAL REQUIREMENTS Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, conducting audits, and hosting inspections, communicating one on one or with larger groups). Ability to independently problem-solve and make recommendations for solutions. As this role can represent Pfizer potentially to third parties or BoH inspectors it is essential that the candidate can remain calm under pressure and is able to adjust and modify their style dependent upon the specific audit situation. Role is primarily office-sitting, standing, walking, and bending. This is inclusive of leading/participating in Webex. Perform complex data analysis for process analysis, troubleshooting or process improvement. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Standard M-F on-site work week, days. No travel required. Other Job Details: Last Date to Apply for Job: 9/24/21 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Engineering #LI-PFE
09/10/2021
Full time
Why Patients Need You Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action. What You Will Achieve Working with Pfizer's dynamic engineering team, the Training and Compliance Coordinator is primarily responsible for ensuring training and compliance within the Engineering Maintenance and Utilities group, including reviewing, evaluating, and working with the team to resolve potential compliance issues within the organization's manufacturing facilities. The individual in this role will ensure that employees are adequately trained and systems are compliant with the rules and regulations of Pfizer as well as industry regulatory agencies. The Training and Compliance Coordinator will be responsible for monitoring, reporting, and aiding in remediating any compliance issues as well as tracking completion of compliance related commitments and manufacturing investigation reports. The Training and Compliance Coordinator will also be responsible for coordinating with Subject Matter Experts (SME's) and other departments during site audits. The Training and Compliance Coordinator will also be responsible for reviewing current group training curricula's, develop role specific modules to minimize unnecessary trainings and conducting training as needed. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Develop and conduct compliance reviews, assessments, analyses, and other business engagement activities within established frameworks to identify, track, and report on the remediation of compliance gaps Create, maintain, and monitor compliance systems to ensure effectiveness in all manufacturing areas Develop and prepare meaningful reporting and tracking of compliance activities to enable effective communication to senior management and all facilities Assist in the ongoing development and enhancement of the compliance program Keep current on emerging compliance issues and trends Assist with and oversee compliance training needs in all departments and areas in Engineering. Supervise the submission of responses to regulatory agencies Develop and maintain relationships with quality organizations. Create, maintain, improve, and track the Company's standard operating procedures and policies in collaboration with Engineering Lead investigation and resolution into compliance concerns Create and manage effective action plans in response to audit discoveries and compliance violations. Assess company operations to determine compliance risk. Ensure all employees are educated on the latest regulations and processes Qualifications Must-Have Bachelor's Degree 5+ years of demonstrated experience in product development, manufacturing science and technology, within the pharmaceutical industry Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, design control The ideal candidate will be well organized, detailed oriented, and have strong problem-solving skills work comfortably under pressure, and deliver on tight deadlines. The Training and Compliance Coordinator should be confident, professional, and self-motivated with a keen interest in the ethical, legal, and regulatory requirements of a business. Top candidates will have outstanding presentation and report writing skills, with the ability to work on their own initiative and as part of a team. Ability to follow written procedures and monitor others for adherence to written procedures. Ability to create or update written procedures with site operations personnel Team player with strong interpersonal skills. Open-minded self-starter with the ability to adapt and problem solve, as well manage multiple tasks concurrently. Nice-to-Have Master's degree Relevant pharmaceutical experience Demonstrated ability to train and coach others Experience with Six Sigma or other operational excellence programs In-depth knowledge of drug substance/drug substance intermediate manufacturing technology PHYSICAL/MENTAL REQUIREMENTS Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, conducting audits, and hosting inspections, communicating one on one or with larger groups). Ability to independently problem-solve and make recommendations for solutions. As this role can represent Pfizer potentially to third parties or BoH inspectors it is essential that the candidate can remain calm under pressure and is able to adjust and modify their style dependent upon the specific audit situation. Role is primarily office-sitting, standing, walking, and bending. This is inclusive of leading/participating in Webex. Perform complex data analysis for process analysis, troubleshooting or process improvement. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Standard M-F on-site work week, days. No travel required. Other Job Details: Last Date to Apply for Job: 9/24/21 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Engineering #LI-PFE
Overview: Title: Freelance Project ManagerCompany/Location: Patients & Purpose/New YorkDepartment/Discipline: Project ManagementCore Competencies: Digital Powerhouse, Organized, Customer Focus, Interpersonal Savvy and CreativityOverview: The Digital Project Manager (PM) is responsible for providing comprehensive project scopes, developing project plans, and working to execute digital projects on behalf of the client, on time and within budget. A Digital Project Manager leads interactive projects and is responsible for their success. At Patients and Purpose success is defined not only as on time and on budget, but meeting client business requirements in a way that demonstrates creativity. A Project Manager leads not only creative and development project teams, but also junior PMs supporting specific projects.Responsibilities:Partner with a crossfunctional team of Account Executives, Copywriters, Art Directors, Developers, Editors and Coordinators to fulfill client requests and expectationsLead discovery process on digital engagements and accurately scope projects, defining project requirements, functional specifications, and partner to finalize success metricsWork in an independent fashion, solve problems, make decisions, and communicate effectively in difficult situationsLead and inspire teams by communicating a vision for the project as well as involving people at the optimal levels for project successLead internal meetings with your brand team and ensure that they meet the stated objectives and stay on agendaManage multiple projects that total a budget in excess of 1MMDevelop project estimates and project plans with support of more senior members of the Project Management team as neededPrepare comprehensive project scopes (deliverables, schedules, budgets, et)Develop and maintain critical issues documents; update and change as needed, communicate changes to the brand teamPrepare billing and forecast incomeProvide Clients with all production schedules and critical milestonesParticipate in all relevant training courses offered internallySupport team and/or agency initiatives as assignedEnsure all deliverables are of the highest qualityQualifications and Experience:Bachelors degree with a minimum of 3 years of interactive project management experience in an advertising agency or similar 5 years is preferred.Experience with the development of largescale websites and a strong understanding of web development technologies, third party applications and platforms, and social mediaWe need someone who is confident and comfortable with the demands this role will require from the very startA familiarity with MS Office, MS Project, bug tracking, wiki and other related project management and common communications toolsPharmaceutical advertising agency experience preferred, not requiredSuperior verbal and written communication skillsStrong collaboration skillsSolid presentation skills; able to present ideas to brand teamsExcellent organizational skills and attention to detailOmnicom Health Group is committed to hiring and developing exceptional talent. We agree that talent is equally distributed, and were focused on developing diverse teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join uswe look forward to getting to know you.
08/31/2021
Full time
Overview: Title: Freelance Project ManagerCompany/Location: Patients & Purpose/New YorkDepartment/Discipline: Project ManagementCore Competencies: Digital Powerhouse, Organized, Customer Focus, Interpersonal Savvy and CreativityOverview: The Digital Project Manager (PM) is responsible for providing comprehensive project scopes, developing project plans, and working to execute digital projects on behalf of the client, on time and within budget. A Digital Project Manager leads interactive projects and is responsible for their success. At Patients and Purpose success is defined not only as on time and on budget, but meeting client business requirements in a way that demonstrates creativity. A Project Manager leads not only creative and development project teams, but also junior PMs supporting specific projects.Responsibilities:Partner with a crossfunctional team of Account Executives, Copywriters, Art Directors, Developers, Editors and Coordinators to fulfill client requests and expectationsLead discovery process on digital engagements and accurately scope projects, defining project requirements, functional specifications, and partner to finalize success metricsWork in an independent fashion, solve problems, make decisions, and communicate effectively in difficult situationsLead and inspire teams by communicating a vision for the project as well as involving people at the optimal levels for project successLead internal meetings with your brand team and ensure that they meet the stated objectives and stay on agendaManage multiple projects that total a budget in excess of 1MMDevelop project estimates and project plans with support of more senior members of the Project Management team as neededPrepare comprehensive project scopes (deliverables, schedules, budgets, et)Develop and maintain critical issues documents; update and change as needed, communicate changes to the brand teamPrepare billing and forecast incomeProvide Clients with all production schedules and critical milestonesParticipate in all relevant training courses offered internallySupport team and/or agency initiatives as assignedEnsure all deliverables are of the highest qualityQualifications and Experience:Bachelors degree with a minimum of 3 years of interactive project management experience in an advertising agency or similar 5 years is preferred.Experience with the development of largescale websites and a strong understanding of web development technologies, third party applications and platforms, and social mediaWe need someone who is confident and comfortable with the demands this role will require from the very startA familiarity with MS Office, MS Project, bug tracking, wiki and other related project management and common communications toolsPharmaceutical advertising agency experience preferred, not requiredSuperior verbal and written communication skillsStrong collaboration skillsSolid presentation skills; able to present ideas to brand teamsExcellent organizational skills and attention to detailOmnicom Health Group is committed to hiring and developing exceptional talent. We agree that talent is equally distributed, and were focused on developing diverse teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join uswe look forward to getting to know you.
CLINICAL PROJECT COORDINATOR LAWRENCEVILLE, NJ Position may start remoted then be onsite 2-3 days a week (expected Oct 2021) Project Description: The candidate will be responsible for assisting in processes related to the Client's TSE (Transmissible Spongiform Encephalopathies) program. Develop an in-depth knowledge of global TSE requirements and be able to apply these requirements to the job. Maintain TSE information repositories within the Client. Effectively network within key business partners to achieve assigned objectives. Evaluate documentation for compliance to current requirements and help with securing documentation for the preparation of the Client's TSE Regulatory Compliance product statements. Required Skills: Top 5 must have skills: cGMP Knowledge 3+ years with MS Office 365 TSE/BSE Knowledge . Biologics experience is preferred. Bachelor's Degree Job Requirements/Education: Excellent oral and written communication skills. Proficient navigation of electronic systems, (e.g., MS Excel, and Adobe Acrobat) including formatting and electronic management of data and information. The candidate must have demonstrated ability to be a strong team member with the ability to drive projects to completion on time. Knowledge of global BSE/TSE regulations and guidances a plus. Knowledge of product formulation and manufacturing processes desirable. Ability to handle multiple projects and prioritize work independently. Basic understanding of the drug development process plus an integrated view of the technical, manufacturing and commercial aspects of the pharmaceutical business. Minimum of 2-5 years of experience in the pharmaceutical industry with a BS degree in a scientific discipline, chemistry or pharmacy preferred. Experience in GMP auditing and/or CMC regulatory a plus. This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #21-03014 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR #LI-BB1 - provided by Dice
08/31/2021
Full time
CLINICAL PROJECT COORDINATOR LAWRENCEVILLE, NJ Position may start remoted then be onsite 2-3 days a week (expected Oct 2021) Project Description: The candidate will be responsible for assisting in processes related to the Client's TSE (Transmissible Spongiform Encephalopathies) program. Develop an in-depth knowledge of global TSE requirements and be able to apply these requirements to the job. Maintain TSE information repositories within the Client. Effectively network within key business partners to achieve assigned objectives. Evaluate documentation for compliance to current requirements and help with securing documentation for the preparation of the Client's TSE Regulatory Compliance product statements. Required Skills: Top 5 must have skills: cGMP Knowledge 3+ years with MS Office 365 TSE/BSE Knowledge . Biologics experience is preferred. Bachelor's Degree Job Requirements/Education: Excellent oral and written communication skills. Proficient navigation of electronic systems, (e.g., MS Excel, and Adobe Acrobat) including formatting and electronic management of data and information. The candidate must have demonstrated ability to be a strong team member with the ability to drive projects to completion on time. Knowledge of global BSE/TSE regulations and guidances a plus. Knowledge of product formulation and manufacturing processes desirable. Ability to handle multiple projects and prioritize work independently. Basic understanding of the drug development process plus an integrated view of the technical, manufacturing and commercial aspects of the pharmaceutical business. Minimum of 2-5 years of experience in the pharmaceutical industry with a BS degree in a scientific discipline, chemistry or pharmacy preferred. Experience in GMP auditing and/or CMC regulatory a plus. This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #21-03014 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR #LI-BB1 - provided by Dice
OverviewMaterials Coordinator Conyers, GeorgiaWith 15 manufacturing facilities strategically located throughout North America and over $1 billion in sales, KCP (operating as KIK Custom Products) is one of North America's largest custom manufacturers of both National Brand and Retailer Brand consumer products. KCP's product lines include Laundry, Household Cleaners, OTC Medicated, Pharmaceutical and Health & Beauty Care, all supported by KCP's in-house technical expertise and value-added services.DIVISION:Pool Division - Conyers, Georgia manufacturing site reporting to the Plant Production Supervisor.Essential Job FunctionsVerify all production supplies are available to all production lines including PPE's, tape, and stretch wrap.Issue all process order packages that may be required to start up production linesVerify with each production line coordinator all materials and components that are needed for the first hour of production are on the floor.Evaluate finished goods inventory to ensure it is properly staged to ship. Rectify any issues with material or components for today's production requirements.Verify designated trailers location - move if it is necessaryHot List - orders needed and orchestrate movementsAttend Tier II meetingsPerform COBI - Rectify any issues through appropriate supervisors and/or line coordinators.Perform cycle counts of one designated location daily. Materials obtained from inventory specialists.Process any external returns physically and in SAP to include Migo transfersReview location TRANSReview any discrepancies noted by warehouse / shipping. Consult with production supervisor to rectify and determine any necessary corrective actions.Review all non-inventory items, PPE's, stocking office supplies, functional supplies and order as needed. Ensure that all next shift production supply carts are prepared to standard.Copy of CTQ's needed for the next shift are ready and staged.Order office supplies and PPE supplies for the entire plant as needed.Receiving of raw materials including check-in, labeling and bar coding pallets data into SAP.Maintain good manufacturing principles including 5s, Safety and adherence to KIK core values.Work collaboratively as part of a team and escalate issues as necessary in a timely fashion.Other duties as may be assigned.QualificationsExperience with Micro Soft Excel, Word, and Outlook. Knowledge in the use of SAP software.Ability to organize and prioritize production shift work. Excellent oral and written communication skillsWork collaboratively as part of a team escalating issues as necessary in a timely fashion.ExperienceOne year of previous experience as a materials coordinator within a manufacturing environment.Experience a variety of clerical tasks utilizing a computer.HS Diploma or GED required.A Career with KIK Offers:KIK offers very competitive salary and comprehensive benefits including health, wellness, dental, vision, life, and disability insurance. You can plan for your future with KIK's retirement savings options including employer match. KIK also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.Thank you for your interest and consideration of a position with KIK Custom Products.KIK is an Equal Employment Opportunity / Affirmative Action employer. Qualified applicants will receive consideration for employment without regards to race, color, religion, sex, or national origin.
03/19/2021
Full time
OverviewMaterials Coordinator Conyers, GeorgiaWith 15 manufacturing facilities strategically located throughout North America and over $1 billion in sales, KCP (operating as KIK Custom Products) is one of North America's largest custom manufacturers of both National Brand and Retailer Brand consumer products. KCP's product lines include Laundry, Household Cleaners, OTC Medicated, Pharmaceutical and Health & Beauty Care, all supported by KCP's in-house technical expertise and value-added services.DIVISION:Pool Division - Conyers, Georgia manufacturing site reporting to the Plant Production Supervisor.Essential Job FunctionsVerify all production supplies are available to all production lines including PPE's, tape, and stretch wrap.Issue all process order packages that may be required to start up production linesVerify with each production line coordinator all materials and components that are needed for the first hour of production are on the floor.Evaluate finished goods inventory to ensure it is properly staged to ship. Rectify any issues with material or components for today's production requirements.Verify designated trailers location - move if it is necessaryHot List - orders needed and orchestrate movementsAttend Tier II meetingsPerform COBI - Rectify any issues through appropriate supervisors and/or line coordinators.Perform cycle counts of one designated location daily. Materials obtained from inventory specialists.Process any external returns physically and in SAP to include Migo transfersReview location TRANSReview any discrepancies noted by warehouse / shipping. Consult with production supervisor to rectify and determine any necessary corrective actions.Review all non-inventory items, PPE's, stocking office supplies, functional supplies and order as needed. Ensure that all next shift production supply carts are prepared to standard.Copy of CTQ's needed for the next shift are ready and staged.Order office supplies and PPE supplies for the entire plant as needed.Receiving of raw materials including check-in, labeling and bar coding pallets data into SAP.Maintain good manufacturing principles including 5s, Safety and adherence to KIK core values.Work collaboratively as part of a team and escalate issues as necessary in a timely fashion.Other duties as may be assigned.QualificationsExperience with Micro Soft Excel, Word, and Outlook. Knowledge in the use of SAP software.Ability to organize and prioritize production shift work. Excellent oral and written communication skillsWork collaboratively as part of a team escalating issues as necessary in a timely fashion.ExperienceOne year of previous experience as a materials coordinator within a manufacturing environment.Experience a variety of clerical tasks utilizing a computer.HS Diploma or GED required.A Career with KIK Offers:KIK offers very competitive salary and comprehensive benefits including health, wellness, dental, vision, life, and disability insurance. You can plan for your future with KIK's retirement savings options including employer match. KIK also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.Thank you for your interest and consideration of a position with KIK Custom Products.KIK is an Equal Employment Opportunity / Affirmative Action employer. Qualified applicants will receive consideration for employment without regards to race, color, religion, sex, or national origin.
Pionyr Immunotherapeutics
South San Francisco, California
Pionyr Immunotherapeutics Inc., a growing South San Francisco-based immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking a Clinical Research Associate (CRA). The Clinical Research Associate will be a key member of the clinical team responsible for supporting the planning, successful implementation and management of one or more clinical trial(s). This is an in-house position, and we are looking to hire a local candidate. The CRA will report to Pionyr's Sr. Director, Clinical Operations and will work closely with our clinical operations and regulatory staff. Specific Responsibilities include (but not limited to): Assisting in the development of study protocols, case report forms, clinical reports, site monitoring visits, and interfacing with site coordinators, field clinical staff, CROs and other company representatives. Build effective relationships across all company functional areas that interact with Clinical Operations as well as with personnel at assigned clinical sites. Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements. Responsible for clinical study document archiving according to regulatory and industry standards. Participate in the design of study manuals, document archiving structure, etc. Participate in site start-up, interim and close-out activities, etc. Review study records including case report forms, consent forms and other materials; may perform site visits to ensure regulatory and study requirements are being fulfilled. Assist in tracking and managing shipments of biological specimens and study-related supplies. Train and assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements and timelines/milestones; serve as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols; monitor and track progress and obstacles and responding to day-to-day problems. Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines, Code of Federal Regulations and study-specific plans and procedures. Assist in identification and hiring of appropriate CROs and third-party study vendors. Assist in evaluation of the performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to the Sr. Director, Clinical Operations. Assist in preparation, negotiation and management of and adherence to study budgets; perform initial review of CRO and vendor invoices Maintain all trial files and other related documents, including trial master file and oversight of site files Perform other duties as requested Qualifications Bachelor's degree in a scientific or health care discipline preferred and/or training or equivalent combination of education and experience. Advanced degree(s) in scientific research, nursing, or business is a plus 2-3 years' experience in supporting clinical studies and drug development, within the biotech/pharmaceutical industry 1+ years' experience in the role of Clinical Research Associate preferred Experience in the preparation, monitoring, and execution of clinical studies is a plus Ability to motivate clinical site personnel to maintain/accelerate to achieve clinical operational milestones An understanding and demonstrated application of Good Clinical Practices and ICH Guidelines is a plus. Able to comply with safety standards and respect privacy and confidentiality. Agree to adhere to regulatory and industry standards on document archiving. Superb verbal and written communication skills. Excellent organizational skills along with strong attention to detail. Ability to work collaboratively with cross-functional teams, external vendors and clinical site staff Experience working with Electronic Data Capture systems as well as Microsoft Office applications including MS Word, Excel, PowerPoint and Outlook, Cloud based storage platforms as well as calendaring programs and database applications required. Ability to effectively work in a fast-paced environment supporting multiple priorities Some domestic and international travel may be required for site training, monitoring responsibilities, etc. Ability to travel up to 20%. How to Apply Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume. Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.
03/09/2021
Full time
Pionyr Immunotherapeutics Inc., a growing South San Francisco-based immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking a Clinical Research Associate (CRA). The Clinical Research Associate will be a key member of the clinical team responsible for supporting the planning, successful implementation and management of one or more clinical trial(s). This is an in-house position, and we are looking to hire a local candidate. The CRA will report to Pionyr's Sr. Director, Clinical Operations and will work closely with our clinical operations and regulatory staff. Specific Responsibilities include (but not limited to): Assisting in the development of study protocols, case report forms, clinical reports, site monitoring visits, and interfacing with site coordinators, field clinical staff, CROs and other company representatives. Build effective relationships across all company functional areas that interact with Clinical Operations as well as with personnel at assigned clinical sites. Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements. Responsible for clinical study document archiving according to regulatory and industry standards. Participate in the design of study manuals, document archiving structure, etc. Participate in site start-up, interim and close-out activities, etc. Review study records including case report forms, consent forms and other materials; may perform site visits to ensure regulatory and study requirements are being fulfilled. Assist in tracking and managing shipments of biological specimens and study-related supplies. Train and assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements and timelines/milestones; serve as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols; monitor and track progress and obstacles and responding to day-to-day problems. Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines, Code of Federal Regulations and study-specific plans and procedures. Assist in identification and hiring of appropriate CROs and third-party study vendors. Assist in evaluation of the performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to the Sr. Director, Clinical Operations. Assist in preparation, negotiation and management of and adherence to study budgets; perform initial review of CRO and vendor invoices Maintain all trial files and other related documents, including trial master file and oversight of site files Perform other duties as requested Qualifications Bachelor's degree in a scientific or health care discipline preferred and/or training or equivalent combination of education and experience. Advanced degree(s) in scientific research, nursing, or business is a plus 2-3 years' experience in supporting clinical studies and drug development, within the biotech/pharmaceutical industry 1+ years' experience in the role of Clinical Research Associate preferred Experience in the preparation, monitoring, and execution of clinical studies is a plus Ability to motivate clinical site personnel to maintain/accelerate to achieve clinical operational milestones An understanding and demonstrated application of Good Clinical Practices and ICH Guidelines is a plus. Able to comply with safety standards and respect privacy and confidentiality. Agree to adhere to regulatory and industry standards on document archiving. Superb verbal and written communication skills. Excellent organizational skills along with strong attention to detail. Ability to work collaboratively with cross-functional teams, external vendors and clinical site staff Experience working with Electronic Data Capture systems as well as Microsoft Office applications including MS Word, Excel, PowerPoint and Outlook, Cloud based storage platforms as well as calendaring programs and database applications required. Ability to effectively work in a fast-paced environment supporting multiple priorities Some domestic and international travel may be required for site training, monitoring responsibilities, etc. Ability to travel up to 20%. How to Apply Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume. Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.
Hi Greetings! Title: Customer Master Data Coordinator Client: EMD Millipore Corporation Duration: 6 Months Contract Location: St. Louis, Missouri 63103 Job Description: A career with us is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. Who we are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science. Your Role: Manage and validate Customer Master Data to comply with the needs of multiple departments, sites, and users while maintaining systems integrity. Processes include the creation, maintenance and conversion of SAP and internet-based master data. Research and evaluate integrity of customer master data to ensure partners are accurately established to facilitate sales, distribution, invoicing, customer service, and receivables. Analyze trends & requests, making use of independent judgment and discretion to manage customer data, as necessary to support findings. In addition, suggest and execute improvement ideas to current processes and systems to exceed expectations. Key responsibilities include: Evaluate and determine appropriate creation set up of SAP customer master data partner functions to ensure high service levels for customer orders. Create and integrate Internet registration profiles, which provides customers a direct link to SAP ordering system via E-Commerce solutions (i.e. Sigma-Aldrich website, B2B, Ariba, EDI). Identify and support process improvement efforts within the department, and across the company, aimed at improving efficiencies in program development and execution, improving service levels, increasing accuracy, and reducing costs associated with maintenance and creation of customer master data. Support key projects and business initiatives for creating, changing, and mapping SAP Customer Master Data records as it relates to customer records Who you are: Education: High school diploma or equivalent work experience. Associate degree or BS/BA desirable. Experience: 1-3 years working with SAP R/3 Master Data and/or Sigma-Aldrich business processes related to Customer Service, Accounts Receivable. Essential and Critical Skills: Broad knowledge of SAP R/3 order processes; and the relationship customer accounts have with e-commerce and accounts receivable processes. Analytical skills - demonstrated problem solving, Root cause analysis and Process Improvement skills with ability to problem solve.
01/28/2021
Full time
Hi Greetings! Title: Customer Master Data Coordinator Client: EMD Millipore Corporation Duration: 6 Months Contract Location: St. Louis, Missouri 63103 Job Description: A career with us is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. Who we are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science. Your Role: Manage and validate Customer Master Data to comply with the needs of multiple departments, sites, and users while maintaining systems integrity. Processes include the creation, maintenance and conversion of SAP and internet-based master data. Research and evaluate integrity of customer master data to ensure partners are accurately established to facilitate sales, distribution, invoicing, customer service, and receivables. Analyze trends & requests, making use of independent judgment and discretion to manage customer data, as necessary to support findings. In addition, suggest and execute improvement ideas to current processes and systems to exceed expectations. Key responsibilities include: Evaluate and determine appropriate creation set up of SAP customer master data partner functions to ensure high service levels for customer orders. Create and integrate Internet registration profiles, which provides customers a direct link to SAP ordering system via E-Commerce solutions (i.e. Sigma-Aldrich website, B2B, Ariba, EDI). Identify and support process improvement efforts within the department, and across the company, aimed at improving efficiencies in program development and execution, improving service levels, increasing accuracy, and reducing costs associated with maintenance and creation of customer master data. Support key projects and business initiatives for creating, changing, and mapping SAP Customer Master Data records as it relates to customer records Who you are: Education: High school diploma or equivalent work experience. Associate degree or BS/BA desirable. Experience: 1-3 years working with SAP R/3 Master Data and/or Sigma-Aldrich business processes related to Customer Service, Accounts Receivable. Essential and Critical Skills: Broad knowledge of SAP R/3 order processes; and the relationship customer accounts have with e-commerce and accounts receivable processes. Analytical skills - demonstrated problem solving, Root cause analysis and Process Improvement skills with ability to problem solve.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . AbbVie is proud to offer highly-qualified first-year law students with an interest in corporate law and diversity an exciting opportunity to join our legal department for an immersive summer internship program at our North Chicago, Lake County, Illinois headquarters location full-time for 10 weeks this summer. As an AbbVie Experiential Intern, you will participate in a paid, 10-week summer program focused on providing students with robust projects throughout the summer. As an intern, you will be located at our corporate headquarters in north suburban Chicago with housing and shuttle services for eligible students. Our hope is to conduct this internship in-person. AbbVie has thorough safety measures in place to protect our employees and guests. However, we continue to closely monitor the COVID-19 situation. Should we deem it not safe in the coming months to host this experience in-person, or if you require a virtual experience, we will always work to accommodate, as applicable, to assure your safety and the safety of others. 2021 Overview Interns will be immersed in AbbVie's in-house corporate legal team learning about, and handling, real-world corporate legal matters in close coordination with AbbVie attorneys. Interns will have substantive exposure to a wide variety of corporate, securities, financing, global legal privacy, benefits, governance, operations, purchasing, real estate, enterprise data and digital health-related tasks on a rotational basis under the supervision of AbbVie attorneys, which may include providing legal research and guidance, drafting memos on legal findings and benchmarking, drafting and evaluating contract clauses, updating the team on proposed rules, observing internal meetings, and participating in strategy meetings with in-house and outside counsel. Corporate law interns will partner closely with a mentor attorney who will provide ongoing guidance and professional development. Since this is a rotational opportunity, they will also have a project coordinator to advise through the rotation and ensure balanced opportunities. Interns will also have an opportunity to meet AbbVie's outside counsel and participate in a variety of other valuable networking opportunities. The scholar will also be encouraged to provide their valuable input on initiatives aimed at enhancing diversity in the legal profession as a whole. By the end of the summer, interns should have attained: Practical experience working for a global, biopharmaceutical company in an interesting and evolving area of law, An understanding of how in-house attorneys provide value to their company as trusted advisors to the business, and Leadership opportunities and experience building business relationships effectively. Qualifications Qualifications Enrolled law students who will complete their first year (1L) at an ABAaccredited law school during 2 Must be enrolled in school the semester following your internship Demonstrated interest in diversity and inclusion in the legal profession Interest in corporate law Ability to perform complex legal research and analysis Excellent communication, leadership, and project management skills Minimum Cumulative GPA: 3.0/4.0 in law school or equivalent; strong academic background Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT can be accommodated). How to Apply? Please provide the following in your application: Current resume A brief letter explaining your interest in the AbbVie 1L Corporate Legal Academy Program, including as it relates to promoting diversity and inclusion in the legal profession or greater community. An unofficial law school transcript. If your first semester grades are not available when you apply, you may submit your application without your law school transcript. As soon as your grades become available, please upload it to your application and email the documentation to Legal Resources. Undergraduate and other graduate school transcripts are optional. Application materials should be uploaded in your application through the AbbVie Career Site and emailed to noting "Corporate Legal Internship" in the subject line. Preference will be given to applications received by January [18], 2021. Salary: Selected legal academy scholars will be paid $1,400 per week for the 10-week program ($14,000). Additional Information AbbVie is an Equal Employment Opportunity employer: gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. We do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information. At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Internship Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/28/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . AbbVie is proud to offer highly-qualified first-year law students with an interest in corporate law and diversity an exciting opportunity to join our legal department for an immersive summer internship program at our North Chicago, Lake County, Illinois headquarters location full-time for 10 weeks this summer. As an AbbVie Experiential Intern, you will participate in a paid, 10-week summer program focused on providing students with robust projects throughout the summer. As an intern, you will be located at our corporate headquarters in north suburban Chicago with housing and shuttle services for eligible students. Our hope is to conduct this internship in-person. AbbVie has thorough safety measures in place to protect our employees and guests. However, we continue to closely monitor the COVID-19 situation. Should we deem it not safe in the coming months to host this experience in-person, or if you require a virtual experience, we will always work to accommodate, as applicable, to assure your safety and the safety of others. 2021 Overview Interns will be immersed in AbbVie's in-house corporate legal team learning about, and handling, real-world corporate legal matters in close coordination with AbbVie attorneys. Interns will have substantive exposure to a wide variety of corporate, securities, financing, global legal privacy, benefits, governance, operations, purchasing, real estate, enterprise data and digital health-related tasks on a rotational basis under the supervision of AbbVie attorneys, which may include providing legal research and guidance, drafting memos on legal findings and benchmarking, drafting and evaluating contract clauses, updating the team on proposed rules, observing internal meetings, and participating in strategy meetings with in-house and outside counsel. Corporate law interns will partner closely with a mentor attorney who will provide ongoing guidance and professional development. Since this is a rotational opportunity, they will also have a project coordinator to advise through the rotation and ensure balanced opportunities. Interns will also have an opportunity to meet AbbVie's outside counsel and participate in a variety of other valuable networking opportunities. The scholar will also be encouraged to provide their valuable input on initiatives aimed at enhancing diversity in the legal profession as a whole. By the end of the summer, interns should have attained: Practical experience working for a global, biopharmaceutical company in an interesting and evolving area of law, An understanding of how in-house attorneys provide value to their company as trusted advisors to the business, and Leadership opportunities and experience building business relationships effectively. Qualifications Qualifications Enrolled law students who will complete their first year (1L) at an ABAaccredited law school during 2 Must be enrolled in school the semester following your internship Demonstrated interest in diversity and inclusion in the legal profession Interest in corporate law Ability to perform complex legal research and analysis Excellent communication, leadership, and project management skills Minimum Cumulative GPA: 3.0/4.0 in law school or equivalent; strong academic background Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT can be accommodated). How to Apply? Please provide the following in your application: Current resume A brief letter explaining your interest in the AbbVie 1L Corporate Legal Academy Program, including as it relates to promoting diversity and inclusion in the legal profession or greater community. An unofficial law school transcript. If your first semester grades are not available when you apply, you may submit your application without your law school transcript. As soon as your grades become available, please upload it to your application and email the documentation to Legal Resources. Undergraduate and other graduate school transcripts are optional. Application materials should be uploaded in your application through the AbbVie Career Site and emailed to noting "Corporate Legal Internship" in the subject line. Preference will be given to applications received by January [18], 2021. Salary: Selected legal academy scholars will be paid $1,400 per week for the 10-week program ($14,000). Additional Information AbbVie is an Equal Employment Opportunity employer: gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. We do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information. At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Internship Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
We are a global specialty chemicals leader. Industries worldwide rely on our essential chemistry in the manufacture of everyday products such as paper, plastics, building materials, food, pharmaceuticals, and personal care items. Building on our nearly 400-year history, the dedication of our 10,000 employees, and our shared commitment to business growth, strong financial performance, safety, sustainability, and innovation, we have established a world-class business and built strong partnerships with our customers. We operate in over 80 countries around the world and our portfolio of industry-leading brands includes Eka, Dissolvine, Trigonox, and Berol. Nouryon has an outstanding opportunity for an Application Manager SAP Authorizations in Houston, TX. A challenging opportunity for an open minded and enthusiastic candidate with great Functional Application Management skills to support in the strategic change and further enhance and support core applications to the Business! As a key member of the IM Services Functional Application support team, working together with the rest of the team on driving business continuity, IT professionalism and user / business satisfaction. Functional area: SAP, GRC, VIM, Ariba, Arkieva and Concur Authorizations (Role management & User Provisioning) Key Responsibilities Application, change (and Project) Support responsibilities. • Proactively and retroactively ensure compliance with identification and access Management policies. • Provide user management (Assignment of roles to users, solve password reset/user lock issues, User creation/removal/changes (incl. FireFighter), Normal (one time) requests or issues / Requests and incidents for the production environment (no enhancements and projects) and Role Management / maintenance for the production environment and for Functional Enhancements in SAP, GRC, VIM, Ariba, Arkieva and Concur. • Deliver enhancements and Monitoring, • Support monitoring of SoD compliance done by business, • FF/SAST and BSL compliance monitoring, • Internal Control related enhancements, • SoD reduction processes/User review processes, • Cleansing programs • (Re-)Assignment of roles to users • Role maintenance for the production environment and for Enhancements and Projects • Project support, based on PMO resource planning • Incident Management: Keeping systems up and running, by applying a controlled process of registering, monitoring and resolving of application related tickets • Monitoring overall performance of application, responsible for integrity of production environment • Maintaining the applications according to the SLA and in line with the regional business needs of involved Business Unit(s) and organization • Periodic standby for emergencies (24x7 availability schedule) • Operationalize priority setting as agreed with the business • Functioning as a 1st escalation point for the 3rd party vendors and the user community on Application Maintenance related services • Signals deviations on policy, standard package matters &, after approval, contributes to changes • Ensuring IM process compliance for area of responsibility • Takes care of proper documentation of the application (technical - process - and end-user documentation) • Play an active role in the CAB / Change Advisory Board • Executes changes & enhancements: describe problem, information analysis, prepare solution, execute system change (self or by third party), test the change, amend user documentation, implementation, after care • Conduct tests as defined in an integration test specification, recording details of any failures and carrying out fault diagnosis • Analyses and Supports Key-users training needs and creates /maintains training material • Periodically visit the customer (sites), to discuss tickets, wishes etc. with key users, and demonstrate visibility • Frequently contact with key users on open tickets& act as co-coordinator for Key User Meetings • Co-responsible for activities to ensure applications functions and operates appropriately • Supporting project handover activities (hand over from deliverables and knowledge from a project to the Application Maintenance teams) for the area of responsibility • Support projects in execution of changes / enhancements • Participating in implementation improvements and optimization projects • Create and checking content of transports Job Requirements Bachelor's Degree, relevant experience and required skills. Technical knowledge and skills: • Professional with sufficient knowledge in own specialized field and has knowledge to adjust the package to NR functional requirements and technical context built on an understanding of the theoretical concepts and principles and their context • Experience with relevant Business Application, Platform, infrastructures, relevant business processes • Familiar with IT standards like ITIL, Cobit, CMM. • Certification in system maintenance / configuration / customizing Business process knowledge skills: • Is aware and has knowledge of business processes that are related to a standard package or specific developments • Builds strong relationships and has overall knowledge of IM/IT and SLA's
01/28/2021
Full time
We are a global specialty chemicals leader. Industries worldwide rely on our essential chemistry in the manufacture of everyday products such as paper, plastics, building materials, food, pharmaceuticals, and personal care items. Building on our nearly 400-year history, the dedication of our 10,000 employees, and our shared commitment to business growth, strong financial performance, safety, sustainability, and innovation, we have established a world-class business and built strong partnerships with our customers. We operate in over 80 countries around the world and our portfolio of industry-leading brands includes Eka, Dissolvine, Trigonox, and Berol. Nouryon has an outstanding opportunity for an Application Manager SAP Authorizations in Houston, TX. A challenging opportunity for an open minded and enthusiastic candidate with great Functional Application Management skills to support in the strategic change and further enhance and support core applications to the Business! As a key member of the IM Services Functional Application support team, working together with the rest of the team on driving business continuity, IT professionalism and user / business satisfaction. Functional area: SAP, GRC, VIM, Ariba, Arkieva and Concur Authorizations (Role management & User Provisioning) Key Responsibilities Application, change (and Project) Support responsibilities. • Proactively and retroactively ensure compliance with identification and access Management policies. • Provide user management (Assignment of roles to users, solve password reset/user lock issues, User creation/removal/changes (incl. FireFighter), Normal (one time) requests or issues / Requests and incidents for the production environment (no enhancements and projects) and Role Management / maintenance for the production environment and for Functional Enhancements in SAP, GRC, VIM, Ariba, Arkieva and Concur. • Deliver enhancements and Monitoring, • Support monitoring of SoD compliance done by business, • FF/SAST and BSL compliance monitoring, • Internal Control related enhancements, • SoD reduction processes/User review processes, • Cleansing programs • (Re-)Assignment of roles to users • Role maintenance for the production environment and for Enhancements and Projects • Project support, based on PMO resource planning • Incident Management: Keeping systems up and running, by applying a controlled process of registering, monitoring and resolving of application related tickets • Monitoring overall performance of application, responsible for integrity of production environment • Maintaining the applications according to the SLA and in line with the regional business needs of involved Business Unit(s) and organization • Periodic standby for emergencies (24x7 availability schedule) • Operationalize priority setting as agreed with the business • Functioning as a 1st escalation point for the 3rd party vendors and the user community on Application Maintenance related services • Signals deviations on policy, standard package matters &, after approval, contributes to changes • Ensuring IM process compliance for area of responsibility • Takes care of proper documentation of the application (technical - process - and end-user documentation) • Play an active role in the CAB / Change Advisory Board • Executes changes & enhancements: describe problem, information analysis, prepare solution, execute system change (self or by third party), test the change, amend user documentation, implementation, after care • Conduct tests as defined in an integration test specification, recording details of any failures and carrying out fault diagnosis • Analyses and Supports Key-users training needs and creates /maintains training material • Periodically visit the customer (sites), to discuss tickets, wishes etc. with key users, and demonstrate visibility • Frequently contact with key users on open tickets& act as co-coordinator for Key User Meetings • Co-responsible for activities to ensure applications functions and operates appropriately • Supporting project handover activities (hand over from deliverables and knowledge from a project to the Application Maintenance teams) for the area of responsibility • Support projects in execution of changes / enhancements • Participating in implementation improvements and optimization projects • Create and checking content of transports Job Requirements Bachelor's Degree, relevant experience and required skills. Technical knowledge and skills: • Professional with sufficient knowledge in own specialized field and has knowledge to adjust the package to NR functional requirements and technical context built on an understanding of the theoretical concepts and principles and their context • Experience with relevant Business Application, Platform, infrastructures, relevant business processes • Familiar with IT standards like ITIL, Cobit, CMM. • Certification in system maintenance / configuration / customizing Business process knowledge skills: • Is aware and has knowledge of business processes that are related to a standard package or specific developments • Builds strong relationships and has overall knowledge of IM/IT and SLA's
The in-house CRA will perform clinical research duties to promote the successful clinical development of HiberCell's proprietary compound. As assigned, responsibilities may include, but are not limited to: Tracking subject recruitment and progression as well as selected study data points Assisting with preparation/collection, review, and tracking of regulatory documents for US and global studies Creating and/or reviewing informed consents, coordinators' manual, pharmacy manual, source documents, and other documentation required for the conduct of a clinical trial Assisting with the creation and maintenance of the trial master file Reviewing clinical data in-house and communicating with study site personnel to resolve data queries Ordering clinical supplies for assigned studies and maintaining accurate records of drug accountability/compliance across the study(s) Participating in the development of protocols and case report forms Conducting/participating in co-monitoring and/or auditing visits Liaising with vendors and investigative site staff Candidate Qualifications: Preference will be given to candidates with the following qualifications: University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology Minimum two years of relevant experience in pharmaceutical/biotechnology setting and oncology research experience Thorough knowledge of ICH Guidelines and GCP/CFR Understanding of serious adverse event reporting process Ability to work independently Excellent computer skills with good working knowledge of a range of computer packages including Word and Excel Excellent verbal and written communication skills and detail oriented Travel Requirements : Minimal travel may be required.
01/26/2021
Full time
The in-house CRA will perform clinical research duties to promote the successful clinical development of HiberCell's proprietary compound. As assigned, responsibilities may include, but are not limited to: Tracking subject recruitment and progression as well as selected study data points Assisting with preparation/collection, review, and tracking of regulatory documents for US and global studies Creating and/or reviewing informed consents, coordinators' manual, pharmacy manual, source documents, and other documentation required for the conduct of a clinical trial Assisting with the creation and maintenance of the trial master file Reviewing clinical data in-house and communicating with study site personnel to resolve data queries Ordering clinical supplies for assigned studies and maintaining accurate records of drug accountability/compliance across the study(s) Participating in the development of protocols and case report forms Conducting/participating in co-monitoring and/or auditing visits Liaising with vendors and investigative site staff Candidate Qualifications: Preference will be given to candidates with the following qualifications: University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology Minimum two years of relevant experience in pharmaceutical/biotechnology setting and oncology research experience Thorough knowledge of ICH Guidelines and GCP/CFR Understanding of serious adverse event reporting process Ability to work independently Excellent computer skills with good working knowledge of a range of computer packages including Word and Excel Excellent verbal and written communication skills and detail oriented Travel Requirements : Minimal travel may be required.
Join a Legacy of Innovation 110 Years & Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary : Lead execution and project management of Global Medical Affairs clinical activities, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The types of clinical activities supported include Collaborative external sponsored studies (CESR)and Investigator Initiated Studies (IIS). A key focus will be the oversight of, and interactions with research sites, regional Medical team and other external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study team. The Assoc. Director will be expected to work in a collaborative, global environment and establish good communication with colleagues in other functions and across regional locations. The Assoc. Director will take responsibility for the clinical operational strategy and overall delivery of the Collaborative study or IIS (i.e. Delivery Lead role) and will represent Clinical Operations on the study team. This position may require future line management responsibility of Clinical Study Managers, who are primarily responsible for the tactical execution of the study. In the absence of Clinical Study Managers, the Associate Director will be expected to take both strategic and tactical roles in order to deliver the study. At this level, the incumbent may be expected to lead a program of studies. Responsibilities: Study Planning, Budget and Execution Work closely with Outsourcing and Legal on RFP, Scope of Work documents, contracts and any other documents necessary to ensure vendors are properly selected and contracted with, in accordance with DS policies and procedures. Oversee contracts once approved with regards to adherence to timelines, budgets and scope of work. Lead the study team to develop a cross-functional, integrated study implementation plan including creation of initial study budget. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall plan agreed by the Project Team. Lead site selection and site qualification discussions with study team and vendors as required. Across all programs, responsible for: oversight of protocol /protocol amendment development, review and approval process incorporating the proper operational delivery aspects and logistics into the protocol development or input into other study related documents including but not limited to ICF, CRF guidelines, project management plans, monitoring plans etc input into other relevant documents related to safety, regulatory, data management, clinical supplies etc. Lead the study team kick-off meetings and subsequent team meetings (DS alone or with vendors). Take responsibility to ensure meeting logistics, agenda and minutes are in accordance with DS standards. Oversee the CESR program and other vendors timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans. Maintain quality and oversight of all study deliverables from start up to delivery of CSR through close collaboration across functions, stakeholders and vendors. As required, the Associate Director provides operational input into regional Medical Affairs studies. Study and vendor and Quality Oversight Responsible for management of the study site relations and any vendor performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to senior management or the appropriate governance committee. Create the budget at study start up and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately. Provide oversight of the CESR to ensure compliance with Daiichi Sankyo's quality measures. Lead the creation of the Quality Oversight Plan (QOP) and ensure study team adherence to the QOP. Be aware of and be able to predict deviations, or potential non-compliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to senior management or the appropriate Governance Committee. Clinical Operations Management/General Participate in the development of procedures and SOP's related to Global Medical Affairs clinical operations activities, in collaboration with Operational Excellence team. Collaborate with Quality Assurance, QC function and regulatory Operations to implement quality standards across all activities, systems and processes. Support the implementation of CAPA in relation to sponsor's audit or regulatory inspection. Provide input into quarterly budget management activities. Participate in GMA driven initiatives Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: A Bachelor's degree in the Life Sciences is required. Master's degree (Life Sciences) is preferred. Assoc. Director level: 7 years clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO). Manager level: 4 years clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO). Experience in Medical Affairs and oncology desired; EAP experience highly desired and preferred. CRA and/or Study Site Coordinator experience is also considered relevant. PMP certificate a plus. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Manager/Assoc. Director, Clinical Trial Mgt & Resources, GMA Oncology City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey
01/20/2021
Full time
Join a Legacy of Innovation 110 Years & Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary : Lead execution and project management of Global Medical Affairs clinical activities, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The types of clinical activities supported include Collaborative external sponsored studies (CESR)and Investigator Initiated Studies (IIS). A key focus will be the oversight of, and interactions with research sites, regional Medical team and other external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study team. The Assoc. Director will be expected to work in a collaborative, global environment and establish good communication with colleagues in other functions and across regional locations. The Assoc. Director will take responsibility for the clinical operational strategy and overall delivery of the Collaborative study or IIS (i.e. Delivery Lead role) and will represent Clinical Operations on the study team. This position may require future line management responsibility of Clinical Study Managers, who are primarily responsible for the tactical execution of the study. In the absence of Clinical Study Managers, the Associate Director will be expected to take both strategic and tactical roles in order to deliver the study. At this level, the incumbent may be expected to lead a program of studies. Responsibilities: Study Planning, Budget and Execution Work closely with Outsourcing and Legal on RFP, Scope of Work documents, contracts and any other documents necessary to ensure vendors are properly selected and contracted with, in accordance with DS policies and procedures. Oversee contracts once approved with regards to adherence to timelines, budgets and scope of work. Lead the study team to develop a cross-functional, integrated study implementation plan including creation of initial study budget. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall plan agreed by the Project Team. Lead site selection and site qualification discussions with study team and vendors as required. Across all programs, responsible for: oversight of protocol /protocol amendment development, review and approval process incorporating the proper operational delivery aspects and logistics into the protocol development or input into other study related documents including but not limited to ICF, CRF guidelines, project management plans, monitoring plans etc input into other relevant documents related to safety, regulatory, data management, clinical supplies etc. Lead the study team kick-off meetings and subsequent team meetings (DS alone or with vendors). Take responsibility to ensure meeting logistics, agenda and minutes are in accordance with DS standards. Oversee the CESR program and other vendors timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans. Maintain quality and oversight of all study deliverables from start up to delivery of CSR through close collaboration across functions, stakeholders and vendors. As required, the Associate Director provides operational input into regional Medical Affairs studies. Study and vendor and Quality Oversight Responsible for management of the study site relations and any vendor performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to senior management or the appropriate governance committee. Create the budget at study start up and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately. Provide oversight of the CESR to ensure compliance with Daiichi Sankyo's quality measures. Lead the creation of the Quality Oversight Plan (QOP) and ensure study team adherence to the QOP. Be aware of and be able to predict deviations, or potential non-compliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to senior management or the appropriate Governance Committee. Clinical Operations Management/General Participate in the development of procedures and SOP's related to Global Medical Affairs clinical operations activities, in collaboration with Operational Excellence team. Collaborate with Quality Assurance, QC function and regulatory Operations to implement quality standards across all activities, systems and processes. Support the implementation of CAPA in relation to sponsor's audit or regulatory inspection. Provide input into quarterly budget management activities. Participate in GMA driven initiatives Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: A Bachelor's degree in the Life Sciences is required. Master's degree (Life Sciences) is preferred. Assoc. Director level: 7 years clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO). Manager level: 4 years clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO). Experience in Medical Affairs and oncology desired; EAP experience highly desired and preferred. CRA and/or Study Site Coordinator experience is also considered relevant. PMP certificate a plus. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Manager/Assoc. Director, Clinical Trial Mgt & Resources, GMA Oncology City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey
B2B Sales Manager As a B2B Sales Manager (Business to Business), you will strengthen and develop your existing and new relationships with a vast range of businesses by presenting our service plans. These service plans provide energy savings to commercial clients that want to operate their business successfully and on a budget. We provide solutions to our clients on a daily basis through sales presentations, contract negotiations, and service agreements. What's the catch? We LISTEN to our CLIENTS' NEEDS and WANTS and we TAILOR the services that our of their BEST interest - providing them savings and quality utility coverage. Job Requirements: B2B Sales Manager Job Type: Full-time Required education: High school or equivalent We are seeking self-disciplined, proven leaders with excellent communication skills, public speaking and presentation skills Preferred Skills include: A minimum of 2 years of sales or sales support experience Proven experience setting and achieving concrete goals Training and/or coaching experience High school and college degree Benefits: You will have excess income which can be earned in three different ways: Residuals from monthly client fees, advanced commission and production bonuses Unlimited sales territory Weekly, Monthly, Quarterly, Annual bonus opportunities Comprehensive initial and ongoing training Company trip opportunities Please visit our website to read more about our company. CANDIDATES WITH ANY OF THE FOLLOWING EXPERIENCE OR INTEREST IN, PLEASE APPLY: Entrepreneurial mindset, entrepreneur, sales, customer service, management, manager, marketing, administrative, HR, entry level, purchasing, director, retail, telecommunications, restaurant, banking, advertising, supervisor, public relations, PR, hotel, hospitality, communications, social services, business and sales psychology, collections, pharmaceutical sales, buyer, recruiter, sales, sales management, marketing management, full time sales, full time marketing, full time management, entry level management, entry level sales, entry level marketing, inside sales, account sales, retail marketing, retail sales, customer service, business management, B2B sales, outside sales, marketing/advertising specialist, entry level sales and marketing, sports minded, management training, team training, consulting, consultant, business opportunity, business development, marketing coordinator, customer care, customer relations, customer acquisition, customer conversion, direct sales, direct marketing, face to face marketing, face to face sales, customer satisfaction, restaurant management, restaurant service, customer service adviser, customer service analyst, team leader, leadership, team building, sports management, sports administration, sports marketing, sports advertising, public relations, leadership sales, sales director, marketing director, promotional marketing, promotional sales, retail sales, retail management, retail marketing, brand manager, brand management, real estate, insurance, telecommunications, restaurant, hotel, communications, buyer, opportunity, advancement opportunity, advancement, growth opportunity, growth, recruiter, marketing professional, sales professional, public relations management, public relations manager, advertising, non-profit, non-for profit, training, trainer, personal trainer, electronics, career focused, career development, career minded, brand ambassador, brand management, brand manager, promotional marketing, promotional sales, entrepreneur, entrepreneur management, entrepreneur mindset.
01/15/2021
Full time
B2B Sales Manager As a B2B Sales Manager (Business to Business), you will strengthen and develop your existing and new relationships with a vast range of businesses by presenting our service plans. These service plans provide energy savings to commercial clients that want to operate their business successfully and on a budget. We provide solutions to our clients on a daily basis through sales presentations, contract negotiations, and service agreements. What's the catch? We LISTEN to our CLIENTS' NEEDS and WANTS and we TAILOR the services that our of their BEST interest - providing them savings and quality utility coverage. Job Requirements: B2B Sales Manager Job Type: Full-time Required education: High school or equivalent We are seeking self-disciplined, proven leaders with excellent communication skills, public speaking and presentation skills Preferred Skills include: A minimum of 2 years of sales or sales support experience Proven experience setting and achieving concrete goals Training and/or coaching experience High school and college degree Benefits: You will have excess income which can be earned in three different ways: Residuals from monthly client fees, advanced commission and production bonuses Unlimited sales territory Weekly, Monthly, Quarterly, Annual bonus opportunities Comprehensive initial and ongoing training Company trip opportunities Please visit our website to read more about our company. CANDIDATES WITH ANY OF THE FOLLOWING EXPERIENCE OR INTEREST IN, PLEASE APPLY: Entrepreneurial mindset, entrepreneur, sales, customer service, management, manager, marketing, administrative, HR, entry level, purchasing, director, retail, telecommunications, restaurant, banking, advertising, supervisor, public relations, PR, hotel, hospitality, communications, social services, business and sales psychology, collections, pharmaceutical sales, buyer, recruiter, sales, sales management, marketing management, full time sales, full time marketing, full time management, entry level management, entry level sales, entry level marketing, inside sales, account sales, retail marketing, retail sales, customer service, business management, B2B sales, outside sales, marketing/advertising specialist, entry level sales and marketing, sports minded, management training, team training, consulting, consultant, business opportunity, business development, marketing coordinator, customer care, customer relations, customer acquisition, customer conversion, direct sales, direct marketing, face to face marketing, face to face sales, customer satisfaction, restaurant management, restaurant service, customer service adviser, customer service analyst, team leader, leadership, team building, sports management, sports administration, sports marketing, sports advertising, public relations, leadership sales, sales director, marketing director, promotional marketing, promotional sales, retail sales, retail management, retail marketing, brand manager, brand management, real estate, insurance, telecommunications, restaurant, hotel, communications, buyer, opportunity, advancement opportunity, advancement, growth opportunity, growth, recruiter, marketing professional, sales professional, public relations management, public relations manager, advertising, non-profit, non-for profit, training, trainer, personal trainer, electronics, career focused, career development, career minded, brand ambassador, brand management, brand manager, promotional marketing, promotional sales, entrepreneur, entrepreneur management, entrepreneur mindset.
Our client, and international pharmaceutical company, is seeking an experienced Document Control Coordinator for a great opportunity at their facility in Norristown, PA Job Details for Document Control Coordinator : Schedule: 8:00am - 5:00pm, Monday - Friday Pay Rate: $24-29 / hour BASED ON RELEVANT EXPERIENCE The Document Control Coordinator is primarily responsible for carrying out document control and project specific duties related to the general implementation and maintenance of our clients Quality Program in accordance with standard operating procedures (SOPs), current good manufacturing practices (cGMP), and customer specifications. Job Responsibilities & Description for Document Control Coordinator : Create and maintain spreadsheets and databases of document reference numbers. Issue such numbers upon request. Ensure documents issued are GMP and Site SOP compliant. Maintain control of SOPs and Policies by: Maintaining the SOP Index Copying SOPs/Policies and issuing authorized SOP/Policy copies Retrieving, reconciling, and destroying superseded/obsolete SOPs/Policies Prepare draft documents including formatting and circulate for approval. Ensure proper electronic and hard-copy archiving and timely destruction of GMP documents. Support audits by obtaining GMP documents and information as required. Provide administrative support to QA and QC staff as required. Support site personnel with document management as needed. Job Requirements for Document Control Coordinator : High School Diploma Minimum of 1 years' experience in administrative or document control functions required. One year working experience any specific working environment, such as office setting or QA department. Computer literacy including Microsoft Office products Ability to create custom spreadsheets and databases using off-the-shelf applications preferred. PeopleShare is the leading Staffing Agency in the region and has temporary to hire and permanent jobs in Pennsylvania (PA) - King of Prussia, Center City Philadelphia, West Chester, Norristown, Conshohocken, Horsham, Lansdale, Montgomeryville, Hatboro, Wayne, Malvern, Media, Plymouth Meeting, Exton, Collegeville, Oaks, Phoenixville, Royersford, Pottstown, Media, Chester, and the Main Line. We have openings for receptionist, data entry, customer service, collections, call center, administrative assistant, accounts payable clerk, accounts receivable clerk, file clerk, warehouse, assembly, production, forklift, machine operators, maintenance mechanics and office managers. IND1 PeopleShare provides equal opportunities to all employees and applicants for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, genetic disposition, neurodiversity, disability, veteran status, or any other protected category or class under federal, state, and/or local laws. This policy applies to all locations and all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
01/15/2021
Full time
Our client, and international pharmaceutical company, is seeking an experienced Document Control Coordinator for a great opportunity at their facility in Norristown, PA Job Details for Document Control Coordinator : Schedule: 8:00am - 5:00pm, Monday - Friday Pay Rate: $24-29 / hour BASED ON RELEVANT EXPERIENCE The Document Control Coordinator is primarily responsible for carrying out document control and project specific duties related to the general implementation and maintenance of our clients Quality Program in accordance with standard operating procedures (SOPs), current good manufacturing practices (cGMP), and customer specifications. Job Responsibilities & Description for Document Control Coordinator : Create and maintain spreadsheets and databases of document reference numbers. Issue such numbers upon request. Ensure documents issued are GMP and Site SOP compliant. Maintain control of SOPs and Policies by: Maintaining the SOP Index Copying SOPs/Policies and issuing authorized SOP/Policy copies Retrieving, reconciling, and destroying superseded/obsolete SOPs/Policies Prepare draft documents including formatting and circulate for approval. Ensure proper electronic and hard-copy archiving and timely destruction of GMP documents. Support audits by obtaining GMP documents and information as required. Provide administrative support to QA and QC staff as required. Support site personnel with document management as needed. Job Requirements for Document Control Coordinator : High School Diploma Minimum of 1 years' experience in administrative or document control functions required. One year working experience any specific working environment, such as office setting or QA department. Computer literacy including Microsoft Office products Ability to create custom spreadsheets and databases using off-the-shelf applications preferred. PeopleShare is the leading Staffing Agency in the region and has temporary to hire and permanent jobs in Pennsylvania (PA) - King of Prussia, Center City Philadelphia, West Chester, Norristown, Conshohocken, Horsham, Lansdale, Montgomeryville, Hatboro, Wayne, Malvern, Media, Plymouth Meeting, Exton, Collegeville, Oaks, Phoenixville, Royersford, Pottstown, Media, Chester, and the Main Line. We have openings for receptionist, data entry, customer service, collections, call center, administrative assistant, accounts payable clerk, accounts receivable clerk, file clerk, warehouse, assembly, production, forklift, machine operators, maintenance mechanics and office managers. IND1 PeopleShare provides equal opportunities to all employees and applicants for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, genetic disposition, neurodiversity, disability, veteran status, or any other protected category or class under federal, state, and/or local laws. This policy applies to all locations and all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Job Summary: The Regulatory Affairs Specialist is responsible for establishing, maintaining, and providing administrative management of the Regulatory Documents in accordance with federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard Operating Procedures (SOPs). Essential Functions · Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP's), Quality procedures (QA/QC), OSHA guidelines and other state and local regulations as applicable, ensuring strict compliance to the study protocol at all times · Generates, facilitates and maintains all study related regulatory documents from prestudy through study close out, ensuring quality, accuracy, and timeliness · Maintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirements · Prepares and maintains records for archiving and/or retrieval · Reviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authority visits. · Works with Clinical Study Managers, clinical staff, IRB, and study Sponsors to resolve site and study related Regulatory concerns issues · Provides administrative and operational support to internal departments and clinical management teams Job Requirements: Qualifications : · Education a Bachelor's Degree in a health field is required. ** Bachelors Preferred but not required with office experience or regulatory experience . Experience · Experience organizing documents, Trial Master File preferred, in a health environment · Minimum of three (3) years of experience in the pharmaceutical industry, supporting clinical study conduct in an operational or training capacity and/or experience in a medically related profession, pharmaceutical, medical device company, or as a clinical research coordinator at an investigative site
01/15/2021
Full time
Job Summary: The Regulatory Affairs Specialist is responsible for establishing, maintaining, and providing administrative management of the Regulatory Documents in accordance with federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard Operating Procedures (SOPs). Essential Functions · Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP's), Quality procedures (QA/QC), OSHA guidelines and other state and local regulations as applicable, ensuring strict compliance to the study protocol at all times · Generates, facilitates and maintains all study related regulatory documents from prestudy through study close out, ensuring quality, accuracy, and timeliness · Maintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirements · Prepares and maintains records for archiving and/or retrieval · Reviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authority visits. · Works with Clinical Study Managers, clinical staff, IRB, and study Sponsors to resolve site and study related Regulatory concerns issues · Provides administrative and operational support to internal departments and clinical management teams Job Requirements: Qualifications : · Education a Bachelor's Degree in a health field is required. ** Bachelors Preferred but not required with office experience or regulatory experience . Experience · Experience organizing documents, Trial Master File preferred, in a health environment · Minimum of three (3) years of experience in the pharmaceutical industry, supporting clinical study conduct in an operational or training capacity and/or experience in a medically related profession, pharmaceutical, medical device company, or as a clinical research coordinator at an investigative site
Regulatory Affairs Specialist II _ Miramar, FL Kelly Services is currently seeking a Regulatory Affairs Specialist II for one of our top clients in Miramar, FL. Duration: 3 - 6 months Hours: Dayshift; Mon - Fri (possible some weekend hours) Pay: $52/hr - $57/hr Job Summary: The Regulatory Affairs Specialist is responsible for establishing, maintaining, and providing administrative management of the Regulatory Documents in accordance with federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard Operating Procedures (SOPs). Essential Functions Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP's), Quality procedures (QA/QC), OSHA guidelines and other state and local regulations as applicable, ensuring strict compliance to the study protocol at all times Generates, facilitates and maintains all study related regulatory documents from pre-study through study close out, ensuring quality, accuracy, and timeliness Maintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirements Prepares and maintains records for archiving and/or retrieval Reviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authority visits. Works with Clinical Study Managers, clinical staff, IRB, and study Sponsors to resolve site and study related Regulatory concerns issues Provides administrative and operational support to internal departments and clinical management teams Qualifications: Education Bachelor's Degree in a health field is required. Experience Experience organizing documents, Trial Master File preferred, in a health environment Minimum of three (3) years of experience in the pharmaceutical industry, supporting clinical study conducted in an operational or training capacity and/or experience in a medically related profession, pharmaceutical, medical device company, or as a clinical research coordinator at an investigative site Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email for questions about the position but please apply online to be considered for the position. Why Kelly? As a Kelly Services employee, you will have access to numerous perks, including: Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Weekly pay and service bonus plans Group-rate insurance options available immediately upon hire* Apply Today! •Available for purchase and administered by a designated third-party vendor Why Kelly ® ? Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly ® At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
01/14/2021
Full time
Regulatory Affairs Specialist II _ Miramar, FL Kelly Services is currently seeking a Regulatory Affairs Specialist II for one of our top clients in Miramar, FL. Duration: 3 - 6 months Hours: Dayshift; Mon - Fri (possible some weekend hours) Pay: $52/hr - $57/hr Job Summary: The Regulatory Affairs Specialist is responsible for establishing, maintaining, and providing administrative management of the Regulatory Documents in accordance with federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard Operating Procedures (SOPs). Essential Functions Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP's), Quality procedures (QA/QC), OSHA guidelines and other state and local regulations as applicable, ensuring strict compliance to the study protocol at all times Generates, facilitates and maintains all study related regulatory documents from pre-study through study close out, ensuring quality, accuracy, and timeliness Maintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirements Prepares and maintains records for archiving and/or retrieval Reviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authority visits. Works with Clinical Study Managers, clinical staff, IRB, and study Sponsors to resolve site and study related Regulatory concerns issues Provides administrative and operational support to internal departments and clinical management teams Qualifications: Education Bachelor's Degree in a health field is required. Experience Experience organizing documents, Trial Master File preferred, in a health environment Minimum of three (3) years of experience in the pharmaceutical industry, supporting clinical study conducted in an operational or training capacity and/or experience in a medically related profession, pharmaceutical, medical device company, or as a clinical research coordinator at an investigative site Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email for questions about the position but please apply online to be considered for the position. Why Kelly? As a Kelly Services employee, you will have access to numerous perks, including: Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Weekly pay and service bonus plans Group-rate insurance options available immediately upon hire* Apply Today! •Available for purchase and administered by a designated third-party vendor Why Kelly ® ? Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly ® At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Description: Join our team of leaders to begin a rewarding career as a Full-Time Material Handler with a starting pay rate of $14.13 per hour! McKesson Pharma supplies pharmaceuticals and pharma supplies to hospitals, pharmacies, physicians' offices, home care agencies, long-term care facilities and surgical centers. Working here is your opportunity to shape an industry that s vital to us all. Use the link below to watch a video to learn more about working for McKesson! Current Need: Our Distribution Center is looking for a dynamic and motivated warehouse associate to join our team. This is a fantastic chance to work for a company that has the rare mix of being a fun, yet high-paced and professional work environment. We currently have the following shift available to add to our team: Full Time - Night shift Position: Sunday and Monday - 6:30pm to 3:00am Tuesday, Wednesday and Thursday - 7:00pm to 3:30am $14.13/HR plus $0.75 shift differential Position Description: The Material Handler job will involve: Performing the physical tasks involved in the shipping, receiving, storing, and distributing of products, materials, parts, supplies and equipment Unpacks and checks goods received against purchase orders or invoices Maintains records of received goods, rejecting unsatisfactory items where necessary Pulls and fills orders Working with RF Scanning equipment to maintain records of merchandise shipped, as well as examine, stock and distribute materials in inventory and on manufacturing lines Posts weights and shipping charges and prepares goods for final shipment May prepare kitting packages for assembly production. May use power equipment including, but not limited to forklift, hand tools, and other devices operated in a warehouse environment while maintaining the highest level of productivity and accuracy Standing and engaging in repetitive movement throughout the entire shift Extensive walking and mandatory overtime as needed is required Passion around working for a leading healthcare distribution company focused on distributing pharmaceuticals to more than 40,000 customers ranging from retail chains, independent retail pharmacies, hospitals, health systems, and other healthcare facilities If you like the sound of these job tasks and perks, then starting your career as a Material Handler is right for you! Keep Your Edge - Stay mentally sharp throughout your shift pulling and picking orders as you strategically get the job done Enjoy excellent benefits including 16 PTO days to all eligible employees, along with paid Holidays Customized medical, dental and vision packages are created to fit you and your family s needs Stay Fit - Get your workout in as you bend, twist, lift up to 50lbs, and walk extensive miles per shift - Employees that participate in our Wellness program can receive Health discounts! Work Hard, Play Hard That s right! Your performance will help you earn financial incentive on top of your regular pay Take advantage of on the job training to operate power equipment including forklift, hand tools, and other devices Most of our Distribution Centers are climate controlled and utilize state of the art systems & equipment Stay comfortable while working in a fast-paced team oriented environment! Minimum Requirements: 1+ years experience Critical Skills: Working knowledge of Material Handling issues Work experience in a face-paced, distribution or warehouse environment or stock room strongly preferred; picking/packing, sorting, loading/unloading, scanning, or various other warehouse functions The ability to work the hours listed above, in addition to overtime. * Overtime in most Distribution Centers is mandatory and typically occurs M-W due to our real-time commitments to our customers Strong reading, addition and subtraction skills needed to manage order specific documentation Education: HS Diploma or Equivalent Physical Requirements: Ability to lift 20 to 50lbs repetitively throughout the course of a shift without assistance (weight varies based on product) Must be able to bend, sit, stand, twist, stoop for long periods of time Able to walk up to 10 miles throughout the course of a shift (steps vary per shift) Working with RF scanning equipment Career Level - IC-Operations Support-O2 **If you require accommodations for this interview - please reach out to us at 877-###-#### as soon as possible to coordinate. McKesson is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history. McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to . Resumes or CVs submitted to this email box will not be accepted. Current employees must apply through the internal career site. Join us at McKesson! Experience: Education: Skills: By submitting your interest in this job, you agree to receive text notifications with additional steps to complete your job application. You will receive up to 6 messages from the number "63879". Message & data rates may apply. Please refer to our privacy policy for more information. By submitting your interest in this job, you agree to receive text notifications with additional steps to complete your job application. You will receive up to 6 messages from the number "63879". Message & data rates may apply. Please refer to our privacy policy for more information. By submitting your interest in this job, you agree to receive text notifications with additional steps to complete your job application. You will receive up to 6 messages from the number "63879". Message & data rates may apply. Please refer to our privacy policy for more information. By submitting your interest in this job, you agree to receive text notifications with additional steps to complete your job application. You will receive up to 6 messages from the number "63879". Message & data rates may apply. Please refer to our privacy policy for more information. By submitting your interest in this job, you agree to receive text notifications with additional steps to complete your job application. You will receive up to 6 messages from the number "63879". Message & data rates may apply. Please refer to our privacy policy for more information. Associated topics: coordinator, dock, entry level, logistics agent, logistics support, material handler, pallet, unloader, warehouse, warehouse support
10/01/2020
Full time
Description: Join our team of leaders to begin a rewarding career as a Full-Time Material Handler with a starting pay rate of $14.13 per hour! McKesson Pharma supplies pharmaceuticals and pharma supplies to hospitals, pharmacies, physicians' offices, home care agencies, long-term care facilities and surgical centers. Working here is your opportunity to shape an industry that s vital to us all. Use the link below to watch a video to learn more about working for McKesson! Current Need: Our Distribution Center is looking for a dynamic and motivated warehouse associate to join our team. This is a fantastic chance to work for a company that has the rare mix of being a fun, yet high-paced and professional work environment. We currently have the following shift available to add to our team: Full Time - Night shift Position: Sunday and Monday - 6:30pm to 3:00am Tuesday, Wednesday and Thursday - 7:00pm to 3:30am $14.13/HR plus $0.75 shift differential Position Description: The Material Handler job will involve: Performing the physical tasks involved in the shipping, receiving, storing, and distributing of products, materials, parts, supplies and equipment Unpacks and checks goods received against purchase orders or invoices Maintains records of received goods, rejecting unsatisfactory items where necessary Pulls and fills orders Working with RF Scanning equipment to maintain records of merchandise shipped, as well as examine, stock and distribute materials in inventory and on manufacturing lines Posts weights and shipping charges and prepares goods for final shipment May prepare kitting packages for assembly production. May use power equipment including, but not limited to forklift, hand tools, and other devices operated in a warehouse environment while maintaining the highest level of productivity and accuracy Standing and engaging in repetitive movement throughout the entire shift Extensive walking and mandatory overtime as needed is required Passion around working for a leading healthcare distribution company focused on distributing pharmaceuticals to more than 40,000 customers ranging from retail chains, independent retail pharmacies, hospitals, health systems, and other healthcare facilities If you like the sound of these job tasks and perks, then starting your career as a Material Handler is right for you! Keep Your Edge - Stay mentally sharp throughout your shift pulling and picking orders as you strategically get the job done Enjoy excellent benefits including 16 PTO days to all eligible employees, along with paid Holidays Customized medical, dental and vision packages are created to fit you and your family s needs Stay Fit - Get your workout in as you bend, twist, lift up to 50lbs, and walk extensive miles per shift - Employees that participate in our Wellness program can receive Health discounts! Work Hard, Play Hard That s right! Your performance will help you earn financial incentive on top of your regular pay Take advantage of on the job training to operate power equipment including forklift, hand tools, and other devices Most of our Distribution Centers are climate controlled and utilize state of the art systems & equipment Stay comfortable while working in a fast-paced team oriented environment! Minimum Requirements: 1+ years experience Critical Skills: Working knowledge of Material Handling issues Work experience in a face-paced, distribution or warehouse environment or stock room strongly preferred; picking/packing, sorting, loading/unloading, scanning, or various other warehouse functions The ability to work the hours listed above, in addition to overtime. * Overtime in most Distribution Centers is mandatory and typically occurs M-W due to our real-time commitments to our customers Strong reading, addition and subtraction skills needed to manage order specific documentation Education: HS Diploma or Equivalent Physical Requirements: Ability to lift 20 to 50lbs repetitively throughout the course of a shift without assistance (weight varies based on product) Must be able to bend, sit, stand, twist, stoop for long periods of time Able to walk up to 10 miles throughout the course of a shift (steps vary per shift) Working with RF scanning equipment Career Level - IC-Operations Support-O2 **If you require accommodations for this interview - please reach out to us at 877-###-#### as soon as possible to coordinate. McKesson is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history. McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to . Resumes or CVs submitted to this email box will not be accepted. Current employees must apply through the internal career site. Join us at McKesson! Experience: Education: Skills: By submitting your interest in this job, you agree to receive text notifications with additional steps to complete your job application. You will receive up to 6 messages from the number "63879". Message & data rates may apply. Please refer to our privacy policy for more information. By submitting your interest in this job, you agree to receive text notifications with additional steps to complete your job application. You will receive up to 6 messages from the number "63879". Message & data rates may apply. Please refer to our privacy policy for more information. By submitting your interest in this job, you agree to receive text notifications with additional steps to complete your job application. You will receive up to 6 messages from the number "63879". Message & data rates may apply. Please refer to our privacy policy for more information. By submitting your interest in this job, you agree to receive text notifications with additional steps to complete your job application. You will receive up to 6 messages from the number "63879". Message & data rates may apply. Please refer to our privacy policy for more information. By submitting your interest in this job, you agree to receive text notifications with additional steps to complete your job application. You will receive up to 6 messages from the number "63879". Message & data rates may apply. Please refer to our privacy policy for more information. Associated topics: coordinator, dock, entry level, logistics agent, logistics support, material handler, pallet, unloader, warehouse, warehouse support
AK Information Technologies Inc
North Chicago, Illinois
Hi We are looking for Project Coordinator @ North Chicago, IL If interested please share me your Updated resume along with the Contact details and Rate AbbVie Pharmaceuticals Project Coordinator - ABBVJP Duration: 1 year Location: North Chicago, IL Local Only Phone and video interview Notes from the call on 09/03: Project Coordinator/Junior PM who has partnered with Project Manager, ideally managing multiple projects simultaneously and/or managing smaller scale projects. Understands functional budget and capital vs expense, tracking, forecasting. Looking for heavier financial experience. Using SAP as a tool for their system of record; ideally would like to see someone using SAP as a tool similarly. They will be assessing the financial data coming in and presenting it to leadership via PowerPoint, etc. Must possess leadership skills. Experience with software enhancement project experience. Must understand the SDLC/SLC. They are NOT looking for an infrastructure heavy person. Will be working with both IT and business stakeholders. Bonus if they understand manufacturing, warehouse, etc. Using Clarity and MS Project and VISIO currently; an understanding of PPM tools will be extremely beneficial. Strong PMO experience is preferred. Requirements: Experience managing large, cross functional projects required Strong written and verbal communication required Experience in Microsoft Applications (PPT, Excel, Word, etc…) required Requires a bachelor's degree and at least 4 years of experience. What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Prior work experience in a PMO for a health and life science organization greatly preferred Experience managing financials across a large portfolio greatly preferred. PMP and ITIL certifications nice to have but not required Nice to haves: Prior work experience in a PMO for a health and life science organization greatly preferred Experience managing financials across a large portfolio greatly preferred. PMP and ITIL certifications nice to have but not required Description: Ensure budgets and forecasts stays consistent to Business and BTS budgets and be able to identify areas to explore across multiple funding sources Understands impacts and working with PM's to align with budget/actuals/LBE's Coordinates and monitors the scheduling, pricing, and technical performance of company programs. Ensures adherence to master plans and schedules, develops solutions to program problems, and directs work of incumbents assigned to program from various departments. Ensures projects are completed on time and within budget. Acts as advisor to program team regarding projects, tasks, and operations. Description Details: Are you open to look at candidates willing to relocate? Local only Years of experience/education and/or certifcations required: Bachelors degree, 4+ years of exp What are the top 3-5 skills requirements should this person have? Organized, Detailed Oriented Sense of Urgency Good Documentation/Follow-up PM Coordinator background What type of environment is this person working in? Group setting Work Schedule (Define days, # of hours)/ Is Overtime offered or required? Mon-Fri 8 hours Does this position offer the ability to work remotely on a regular basis or is it an on-site role? Remote during covid but will be onsite If you are comfortable with above position please share me bellow details and expected rate First Name: Last Name: Contact no: Email ID: Current Location: Visa Status: Education Credentials: Availability for Joining : Best Time to Reach you : Total Experience: Last 4 Digits SSN : DOB : LinkedIn ID : Thank you !! Sales Manager Alex | AK Information Technologies Inc, P: 5105 Tollview D |, Suite 195 | Rolling Meadows| IL 60008 sales(AT)ak-infotech(DOT)com - provided by Dice
09/30/2020
Full time
Hi We are looking for Project Coordinator @ North Chicago, IL If interested please share me your Updated resume along with the Contact details and Rate AbbVie Pharmaceuticals Project Coordinator - ABBVJP Duration: 1 year Location: North Chicago, IL Local Only Phone and video interview Notes from the call on 09/03: Project Coordinator/Junior PM who has partnered with Project Manager, ideally managing multiple projects simultaneously and/or managing smaller scale projects. Understands functional budget and capital vs expense, tracking, forecasting. Looking for heavier financial experience. Using SAP as a tool for their system of record; ideally would like to see someone using SAP as a tool similarly. They will be assessing the financial data coming in and presenting it to leadership via PowerPoint, etc. Must possess leadership skills. Experience with software enhancement project experience. Must understand the SDLC/SLC. They are NOT looking for an infrastructure heavy person. Will be working with both IT and business stakeholders. Bonus if they understand manufacturing, warehouse, etc. Using Clarity and MS Project and VISIO currently; an understanding of PPM tools will be extremely beneficial. Strong PMO experience is preferred. Requirements: Experience managing large, cross functional projects required Strong written and verbal communication required Experience in Microsoft Applications (PPT, Excel, Word, etc…) required Requires a bachelor's degree and at least 4 years of experience. What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Prior work experience in a PMO for a health and life science organization greatly preferred Experience managing financials across a large portfolio greatly preferred. PMP and ITIL certifications nice to have but not required Nice to haves: Prior work experience in a PMO for a health and life science organization greatly preferred Experience managing financials across a large portfolio greatly preferred. PMP and ITIL certifications nice to have but not required Description: Ensure budgets and forecasts stays consistent to Business and BTS budgets and be able to identify areas to explore across multiple funding sources Understands impacts and working with PM's to align with budget/actuals/LBE's Coordinates and monitors the scheduling, pricing, and technical performance of company programs. Ensures adherence to master plans and schedules, develops solutions to program problems, and directs work of incumbents assigned to program from various departments. Ensures projects are completed on time and within budget. Acts as advisor to program team regarding projects, tasks, and operations. Description Details: Are you open to look at candidates willing to relocate? Local only Years of experience/education and/or certifcations required: Bachelors degree, 4+ years of exp What are the top 3-5 skills requirements should this person have? Organized, Detailed Oriented Sense of Urgency Good Documentation/Follow-up PM Coordinator background What type of environment is this person working in? Group setting Work Schedule (Define days, # of hours)/ Is Overtime offered or required? Mon-Fri 8 hours Does this position offer the ability to work remotely on a regular basis or is it an on-site role? Remote during covid but will be onsite If you are comfortable with above position please share me bellow details and expected rate First Name: Last Name: Contact no: Email ID: Current Location: Visa Status: Education Credentials: Availability for Joining : Best Time to Reach you : Total Experience: Last 4 Digits SSN : DOB : LinkedIn ID : Thank you !! Sales Manager Alex | AK Information Technologies Inc, P: 5105 Tollview D |, Suite 195 | Rolling Meadows| IL 60008 sales(AT)ak-infotech(DOT)com - provided by Dice