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Lawrence White
Community Specialist
5 months ago

Takeda Hiring Events this week!

Takeda is hosting exciting hiring events you don't want to miss if you're actively seeking good paying employment opportunities in the Round Lake, IL area.

Talk with Takeda hiring managers about immediate job opportunities at one of these two hiring events...

Job Duties & General Responsibilities Include:

  • Support all local manufacturing operations.
  • Supply components, small parts, glassware, tubing, etc. to cell culture and purification areas.
  • Operate general production equipment (such as parts washers, autoclave, stir plates, etc.)
  • Complete relevant paperwork following GDP/GMP guidelines.
  • Manually clean all portable equipment and small parts.
  • Participate on Continuous Improvement Teams.
  • Receive and distribute supplies into the production area as necessary.
  • Perform daily cleaning of the production area to maintain in GMP fashion.
  • Prepare media and buffer solutions.

Use the links above to get more event details and register to attend for you interview appointment today!

Application Tips: Having an optimized resume in today's employment environment is essential! You can get more resume building tips on this quick read Improve Your Resume + Land That Job!.

If you decide to apply for this exciting job opportunity, make sure to include an optimize resume with your online application. Doing this will significantly improve your application rating and increase your probability to get called in for an interview.

When you have your resume build, upload it onto your Jobcase Profile or use the resume builder option to create your new optimized resume.

You can also maximize your hiring potential for this and other job opportunities by following these quick and easy online application strategies, see Jobcase app: profile tips to get hired for more information.

Feel free to reach right back to us on this post if you have any questions before you apply.

Thanks & Good Luck!

#Takeda #hiringnews #jobsearch #fulltime #production #manufacturing #RoundLake #Illinois

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over 6 months ago

Associate Program Leader - Clinical Operations Takeda Pharmaceuticals - Cambridge, Massachusetts

Please message me so i can sent you the application Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Program Leader - Clinical Operations in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Program Leader working on the Clinical Operations team, you will be empowered to lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan, and a typical day will include:

OBJECTIVES:

In close collaboration with Clinical Operations Program Leads

Responsible for oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversight of Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. The assigned clinical studies may be high complexity or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.

ACCOUNTABILITIES:

Accountable for planning and operational strategy for assigned clinical trialsProvides subject matter expertise and operational input into protocol synopsis and final protocol document Challenges study team to ensure operational feasibility, inclusive of patient and site burden Validates budget and ensures impacts are adequately addressed Participates in country and site selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy Challenges study team to ensure timelines meet the needs of the clinical development plan With Strategic Partner(s) and/or other CROs, support the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place Provide support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s) , Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Leader(s) ; serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted; Specific areas of sponsor oversight include, but are not limited to:Review and approval of key risk based monitoring documents/plans, periodic review of outputs, decisions and actions related to risk based monitoring Review and endorsement of Data Management Strategy and Operational Plan, a document which focuses on data concepts and data management principles at the study level Study team (SET/CTWG) meeting attendance when necessary; regular review of meeting agendas and minutes Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study Documented review and monitoring of issues, risks and decisions at the study level In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

Education: Bachelor’s Degree or international equivalent required, Life Sciences preferred.

Skills:

Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Demonstrated excellence in project/program management and matrix leadership Excellent teamwork, organizational, interpersonal, and problem solving skills Fluent business English (oral and written) Experience: 5+ years’ experience in pharmaceutical industry and/or clinical research organization, sponsor preferred, including 3+ years clinical study management preferred. Experience must include early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to sit and stand for long periods of time. Carrying, handling and reaching for objects.Manual dexterity to operate office equipment i.e. computers, phones, etc. TRAVEL REQUIREMENTS:

Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.

WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine

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over 6 months ago

Manager, Clinical Data Solutions Takeda Pharmaceuticals - Cambridge, Massachusetts

Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Clinical Data Solutions in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Clinical Data Solutions team, you will be empowered to support the Takeda portfolio and participate in oversight activities, and a typical day will include:

POSITION OBJECTIVES:

Responsible for timely and high quality data management deliverables supporting the Takeda portfolio. Confirms asset and study level strategies and services are being implemented at the study level, including the application of standards. Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. Activities include from protocol synopsis through database release and submission Contributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs including the verification of monthly invoices. Acts as a first point of contact for CRO partners seeking sponsor input on study level problem solving and decision making. Serves as an expert for clinical data management best practices and acts as an ambassador on CDISC standards. POSITION ACCOUNTABILITIES:

Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions. Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality. Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. Acts as a process expert for operational and oversight models. Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. May prepare metrics to support the function’s KPIs. Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones. Confirms archival and inspection readiness of all Data Management Trial Master File (TMF) documents Verifies external Data Management SOWs and timelines to ensure accuracy of invoices, investigates variances and supports forecasting. Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. Other duties as assigned EDUCATION, EXPERIENCE AND SKILLS:

BS/BA required preferably in a health-related, life science area and with a minimum of 6 years data management and/or drug development experience. Proven track record of strong project management skills and experience managing data management activities for large drug development programs Experience with all phases of development and at least 2 therapeutic areas. Ability to handle multiple development programs simultaneously. NDA/CTD Experience. Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance. Good understanding of CDISC standards, and experience implementing standards. Strong knowledge of clinical study reporting requirements including SAS programming. Advanced knowledge of office software (Microsoft Office). Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles. Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools. Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes. Demonstrated strong matrix leadership and communication skills Able to influence without authority Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo Pragmatic and support change Is comfortable with ambiguity PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to sit and stand for long periods of time. Carrying, handling and reaching for objects. Manual dexterity to operate office equipment i.e. computers, phones, etc. TRAVEL REQUIREMENTS:

Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs

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over 6 months ago

Manager, Clinical Data Solutions

Manager, Clinical Data Solutions Takeda Pharmaceuticals - Cambridge, Massachusetts

Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Clinical Data Solutions in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Clinical Data Solutions team, you will be empowered to support the Takeda portfolio and participate in oversight activities, and a typical day will include:

POSITION OBJECTIVES:

Responsible for timely and high quality data management deliverables supporting the Takeda portfolio. Confirms asset and study level strategies and services are being implemented at the study level, including the application of standards. Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. Activities include from protocol synopsis through database release and submission Contributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs including the verification of monthly invoices. Acts as a first point of contact for CRO partners seeking sponsor input on study level problem solving and decision making. Serves as an expert for clinical data management best practices and acts as an ambassador on CDISC standards. POSITION ACCOUNTABILITIES:

Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions. Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality. Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. Acts as a process expert for operational and oversight models. Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. May prepare metrics to support the function’s KPIs. Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones. Confirms archival and inspection readiness of all Data Management Trial Master File (TMF) documents Verifies external Data Management SOWs and timelines to ensure accuracy of invoices, investigates variances and supports forecasting. Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. Other duties as assigned EDUCATION, EXPERIENCE AND SKILLS:

BS/BA required preferably in a health-related, life science area and with a minimum of 6 years data management and/or drug development experience. Proven track record of strong project management skills and experience managing data management activities for large drug development programs Experience with all phases of development and at least 2 therapeutic areas. Ability to handle multiple development programs simultaneously. NDA/CTD Experience. Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance. Good understanding of CDISC standards, and experience implementing standards. Strong knowledge of clinical study reporting requirements including SAS programming. Advanced knowledge of office software (Microsoft Office). Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles. Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools. Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes. Demonstrated strong matrix leadership and communication skills Able to influence without authority Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo Pragmatic and support change Is comfortable with ambiguity PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to sit and stand for long periods of time. Carrying, handling and reaching for objects. Manual dexterity to operate office equipment i.e. computers, phones, etc. TRAVEL REQUIREMENTS:

Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days

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over 6 months ago

Manager, Clinical Data Solutions Takeda Pharmaceuticals - Cambridge, Massachusetts

Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Clinical Data Solutions in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Clinical Data Solutions team, you will be empowered to support the Takeda portfolio and participate in oversight activities, and a typical day will include:

POSITION OBJECTIVES:

Responsible for timely and high quality data management deliverables supporting the Takeda portfolio. Confirms asset and study level strategies and services are being implemented at the study level, including the application of standards. Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. Activities include from protocol synopsis through database release and submission Contributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs including the verification of monthly invoices. Acts as a first point of contact for CRO partners seeking sponsor input on study level problem solving and decision making. Serves as an expert for clinical data management best practices and acts as an ambassador on CDISC standards. POSITION ACCOUNTABILITIES:

Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions. Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality. Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. Acts as a process expert for operational and oversight models. Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. May prepare metrics to support the function’s KPIs. Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones. Confirms archival and inspection readiness of all Data Management Trial Master File (TMF) documents Verifies external Data Management SOWs and timelines to ensure accuracy of invoices, investigates variances and supports forecasting. Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. Other duties as assigned EDUCATION, EXPERIENCE AND SKILLS:

BS/BA required preferably in a health-related, life science area and with a minimum of 6 years data management and/or drug development experience. Proven track record of strong project management skills and experience managing data management activities for large drug development programs Experience with all phases of development and at least 2 therapeutic areas. Ability to handle multiple development programs simultaneously. NDA/CTD Experience. Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance. Good understanding of CDISC standards, and experience implementing standards. Strong knowledge of clinical study reporting requirements including SAS programming. Advanced knowledge of office software (Microsoft Office). Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles. Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools. Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes. Demonstrated strong matrix leadership and communication skills Able to influence without authority Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo Pragmatic and support change Is comfortable with ambiguity PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to sit and stand for long periods of time. Carrying, handling and reaching for objects. Manual dexterity to operate office equipment i.e. computers, phones, etc. TRAVEL REQUIREMENTS:

Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs

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