Engineering Structures Elsevier Jobs in Wayside New Jersey
105 positions found — Page 11
N
Counsel - Counseling Practice Group
Salary not disclosed
Position Overview: Are you looking to join a team that is passionate about what they do? Are you someone who embraces both a growth mindset and feedback-rich culture?
We are NFC. We are comprised of top talent at every level on our bi-coastal team, where our team is guided by integrity and committed to finding the best possible solutions, prioritizing collaboration and strategic thinking. We stress the importance of balance while supporting one’s whole self and it’s our ambition to truly make a difference for both or clients and our team members.
Our commitment to our attorneys and their ability to lead their own growth and professional development is an integral part of our foundation and reflected in our department structure. With separate departments for Employment Counseling/Training/Investigations and Employment Litigation we empower our attorneys to focus on the area and skillset they are most passionate about. At NFC, we believe feedback is fuel and we team with our employees to build a workplace that provides an opportunity for significant growth and achievement and our incredibly high retention rate reflects the longstanding dedication of our team.
We are not your typical law firm and we’d love to hear how your extraordinary experience, talents and commitment may fit ours. . . .
NFC is looking to hire an experienced employment law Counsel for our Chatham, New Jersey office. This position will be filled by a highly motivated, detail-oriented individual who excels in a fast paced, entrepreneurial environment that values top-quality work and positive contributions to the workplace. This particular position is perfect for an experienced employment attorney seeking a non-litigation position or an in-house role, as the position is focused on a wide range of advisory work.
Classification: Exempt Position
Location: Hybrid – work in NFC’s Chatham, NJ office a minimum of two (2) days per week. Under NFC’s current hybrid model (which is subject to change), in-office days are every Wednesday, with a second day on either Tuesday or Thursday. Must be flexible and willing to work in person for additional days as needed for coverage and/or other business needs.
Hours: 1,400 – 1,600 hour Billable Hour Requirement annually, with flexibility and open discussion based on candidate experience and firm needs/Hybrid In-Office Role
Reports to: Counseling Practice Group
Essential Functions:
Applicant must have a minimum of at least 10 years of substantive employment law experience, including experience advising clients on a range of employment law issues.
Responsibilities are focused on independently managing all aspects of employment counseling matters for private sector corporate clients headquartered in New Jersey and New York, specifically:
- Advising clients on a wide variety of employment issues, including hiring, workplace policies, investigations, agreements, performance management, separation, and leaves of absence
- Communicating with clients on a regular basis, including delivering advice via phone or virtual platforms and drafting comprehensive business-focused advisory emails
- Preparation of workplace agreements and policies (e.g., Handbooks, Separation Agreements, Restrictive Covenant Agreements, etc.)
- Handling agency matters, including EEOC and DOL (and similar state/local agencies)
- Oversight of associates in Counseling Practice Group on employment law work
- Training clients on employment law and DEI issues
- Development and deepening of client relationships
- Participation in NFC webinars and seminars
- Participation in monthly Counseling Group meetings
- Participation in other firm-related events and professional development meetings
- Voluntary opportunities for NFC committees including DEI, Social Responsibility (Pro Bono), and Culture Club
Skills Required:
- Must be admitted to the NJ bar (NY Bar Admission is a plus)
- Exceptional legal writing and communication skills
- Excellent research skills
- Strong attention to detail
- Strong interpersonal skills
- The ability to work collaboratively and positively in a dynamic team environment
- The ability to proactively manage a team and all litigation deadlines
- The ability to identify and resolve problems quickly
- The ability to manage multiple clients and matters
- Experience conducting third party investigations a plus
- Any other state bar license a plus
Salary Range (Salary Rangebased on full-time): 180k – 210k
The Firm is providing this good-faith salary range to comply with applicable law and based on 1600 BH Requirement. The applicant’s final salary will depend on a number of factors, including the applicant’s skills, experience, and years of practicing employment law.
Performance and Hours-Based Bonuses: This position is also eligible for an annual discretionary performance-based bonus (percentage of salary); an hours-based bonus (based on meeting billable hours).
Total Compensation Package Range (Salary plus Maximum Performance and Hours-Based Bonuses): $200,000 to $230,000 this salary range has been prorated for 1600 Billable Hour Requirement
Additional Bonuses: Discretionary overage bonus (based on exceeding billable hours); origination bonus, and employee referral bonus.
Benefits: This position is eligible for many additional benefits, including paid time off, sick time, medical and dental benefits, and 401K contribution (and matching).
Not Specified
J
Supplier Quality Engineer
🏢 Jobot
Salary not disclosed
Supplier Quality Engineer Needed For Leading Contract Manufacturer This Jobot Job is hosted by: Kevin Finlay Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $100,000
- $120,000 per year A bit about us: My client is a leading contract manufacturer and is growing! They are looking to add a Quality Engineer focused on supplier quality to their team.
In this role you will be responsible for managing supplier quality activities, developing and maintaining supplier relationships, conducting supplier audits, and driving continuous improvement initiatives.
Why join us? Compensation Up To $120,000 Medical, Dental and Vision 401 (k) with company match Holiday, Vacation and Sick Time Tuition Reimbursement Health Savings Accounts (HAS) Flexible Spending Accounts (FSA) Cigna Wellness Incentive Program Employee Assistance Program (EAP) Job Details Responsibilities: Supplier Quality Management Develop and implement supplier quality requirements, including incoming inspection processes, supplier scorecards, and corrective actions.
Conduct supplier audits to ensure compliance with ISO 9001, IATF 16949, ISO 13485, and other relevant industry standards.
Work with suppliers to improve product quality, reduce defects, and enhance overall process reliability.
Evaluate new and existing suppliers for risk assessment and capability analysis.
Quality Assurance & Compliance Collaborate with cross-functional teams to resolve supplier quality issues and implement effective corrective actions.
Lead problem-solving activities (8D, Root Cause Analysis, FMEA) related to supplier-related defects and non-conformances.
Ensure supplier processes comply with regulatory and customer requirements.
Maintain supplier-related quality documentation, including PPAP, FAI, control plans, and certifications.
Drive continuous improvement initiatives with suppliers to enhance quality, efficiency, and cost-effectiveness.
Provide training and guidance to suppliers on quality systems, best practices, and defect prevention.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Jobot is an Equal Opportunity Employer.
We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws.
Jobot also prohibits harassment of applicants or employees based on any of these protected categories.
It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization.
Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at /legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners.
Frequency varies for text messages.
Message and data rates may apply.
Carriers are not liable for delayed or undelivered messages.
You can reply STOP to cancel and HELP for help.
You can access our privacy policy here: /privacy-policy
Salary: $100,000
- $120,000 per year A bit about us: My client is a leading contract manufacturer and is growing! They are looking to add a Quality Engineer focused on supplier quality to their team.
In this role you will be responsible for managing supplier quality activities, developing and maintaining supplier relationships, conducting supplier audits, and driving continuous improvement initiatives.
Why join us? Compensation Up To $120,000 Medical, Dental and Vision 401 (k) with company match Holiday, Vacation and Sick Time Tuition Reimbursement Health Savings Accounts (HAS) Flexible Spending Accounts (FSA) Cigna Wellness Incentive Program Employee Assistance Program (EAP) Job Details Responsibilities: Supplier Quality Management Develop and implement supplier quality requirements, including incoming inspection processes, supplier scorecards, and corrective actions.
Conduct supplier audits to ensure compliance with ISO 9001, IATF 16949, ISO 13485, and other relevant industry standards.
Work with suppliers to improve product quality, reduce defects, and enhance overall process reliability.
Evaluate new and existing suppliers for risk assessment and capability analysis.
Quality Assurance & Compliance Collaborate with cross-functional teams to resolve supplier quality issues and implement effective corrective actions.
Lead problem-solving activities (8D, Root Cause Analysis, FMEA) related to supplier-related defects and non-conformances.
Ensure supplier processes comply with regulatory and customer requirements.
Maintain supplier-related quality documentation, including PPAP, FAI, control plans, and certifications.
Drive continuous improvement initiatives with suppliers to enhance quality, efficiency, and cost-effectiveness.
Provide training and guidance to suppliers on quality systems, best practices, and defect prevention.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Jobot is an Equal Opportunity Employer.
We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws.
Jobot also prohibits harassment of applicants or employees based on any of these protected categories.
It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization.
Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at /legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners.
Frequency varies for text messages.
Message and data rates may apply.
Carriers are not liable for delayed or undelivered messages.
You can reply STOP to cancel and HELP for help.
You can access our privacy policy here: /privacy-policy
Not Specified
D
Associate Director, Regulatory Affairs CMC and Digital Transformation
Salary not disclosed
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines.
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug projects consistent with the company goals.
Participate on G-RACMC teams and support or lead on Component teams and/or serve as G-RACMC lead or regional submission lead.
Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams leading to sound scientific development programs and successful registration for new compounds.
Performs collaborative authoring with other RACMC regional team members and subject matter experts for Health Authority (HA) submission, HA meetings, and responses to HA queries.
Support company goals to building filing strategies that lead to efficient submission timeline and approvals in assigned region.
Digital Transformation Responsibilities: The Associate Director, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and next-generation digital capabilities.
This role is critical to enabling the future of regulatory submissions, modernizing end-to-end CMC data management, and positioning the company for global competitiveness in an increasingly data-driven biopharmaceutical landscape.
Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Responsibilities Organize and manage the preparation (content and format) of all types of submissions to Health Authorities.
Coordinates activities required for timely and accurate reporting of information to existing submissions.
Supervise the identification and compilation of required documentation for submission.
Prioritizes workload.
Evaluate content and adequacy of submissions and identify deficiencies against regulatory guidance’s or internal data bases.
Facilitate and support liaison activities with functional groups within Daiichi Sankyo, Inc.
related to assigned products/project areas such as the clinical supplies organization, Reg Operations, Medical Affairs and labelling.
Participates in meetings with Health Authorities.
Prepares internal functional teams for these interactions to build strong relationships with FDA and secure successful meeting outcomes.
Coordinates preparation, authors, and finalizes meeting materials to include meeting requests, briefing books and meeting minutes.
Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical seminars, global forums or trip reports.
Participates on external industry consortiums (DS Consortium and Biophorum) to understand industry standards and contribute to policies and or standards.
Identifies areas for process /procedure improvements and works on improvement implementation.
Provides training on evolving regulations.
This could involve Global RACMC teams or cross-functional initiatives within the company.
Lead the transition to structured CMC data, including data standards, metadata models, and systems that support machine-readable regulatory submissions.
Drive digital modernization by implementing tools for structured content authoring, automated data transfer, and data-driven dossier creation.
Enable automation, AI, and analytics to reduce manual data handling, improve data integrity, and enhance decision-making across CMC functions.
Partner cross-functionally with CMC, Quality, Manufacturing, Technical Operations, Regulatory, and IT to ensure alignment and readiness for structured data capabilities.
Manage organizational change, including capability building, training, and communication to support adoption of new digital processes.
Monitor global regulatory and industry trends and lead internal initiatives that position the company for future structured submission expectations and digital regulatory innovations.
Qualifications Education Qualifications Bachelor's Degree Life Science Degree required Master's Degree preferred PharmD preferred Experience Qualifications 7 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields required Experience in Digital Transformation within Regulatory CMC required Experience in international Regulatory Affairs– CMC preferred Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Travel Requirements Ability to travel up to 10% of the time.
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.
Salary Range: USD$159.440,00
- USD$239.160,00 Download Our Benefits Summary PDF
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug projects consistent with the company goals.
Participate on G-RACMC teams and support or lead on Component teams and/or serve as G-RACMC lead or regional submission lead.
Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams leading to sound scientific development programs and successful registration for new compounds.
Performs collaborative authoring with other RACMC regional team members and subject matter experts for Health Authority (HA) submission, HA meetings, and responses to HA queries.
Support company goals to building filing strategies that lead to efficient submission timeline and approvals in assigned region.
Digital Transformation Responsibilities: The Associate Director, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and next-generation digital capabilities.
This role is critical to enabling the future of regulatory submissions, modernizing end-to-end CMC data management, and positioning the company for global competitiveness in an increasingly data-driven biopharmaceutical landscape.
Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Responsibilities Organize and manage the preparation (content and format) of all types of submissions to Health Authorities.
Coordinates activities required for timely and accurate reporting of information to existing submissions.
Supervise the identification and compilation of required documentation for submission.
Prioritizes workload.
Evaluate content and adequacy of submissions and identify deficiencies against regulatory guidance’s or internal data bases.
Facilitate and support liaison activities with functional groups within Daiichi Sankyo, Inc.
related to assigned products/project areas such as the clinical supplies organization, Reg Operations, Medical Affairs and labelling.
Participates in meetings with Health Authorities.
Prepares internal functional teams for these interactions to build strong relationships with FDA and secure successful meeting outcomes.
Coordinates preparation, authors, and finalizes meeting materials to include meeting requests, briefing books and meeting minutes.
Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical seminars, global forums or trip reports.
Participates on external industry consortiums (DS Consortium and Biophorum) to understand industry standards and contribute to policies and or standards.
Identifies areas for process /procedure improvements and works on improvement implementation.
Provides training on evolving regulations.
This could involve Global RACMC teams or cross-functional initiatives within the company.
Lead the transition to structured CMC data, including data standards, metadata models, and systems that support machine-readable regulatory submissions.
Drive digital modernization by implementing tools for structured content authoring, automated data transfer, and data-driven dossier creation.
Enable automation, AI, and analytics to reduce manual data handling, improve data integrity, and enhance decision-making across CMC functions.
Partner cross-functionally with CMC, Quality, Manufacturing, Technical Operations, Regulatory, and IT to ensure alignment and readiness for structured data capabilities.
Manage organizational change, including capability building, training, and communication to support adoption of new digital processes.
Monitor global regulatory and industry trends and lead internal initiatives that position the company for future structured submission expectations and digital regulatory innovations.
Qualifications Education Qualifications Bachelor's Degree Life Science Degree required Master's Degree preferred PharmD preferred Experience Qualifications 7 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields required Experience in Digital Transformation within Regulatory CMC required Experience in international Regulatory Affairs– CMC preferred Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Travel Requirements Ability to travel up to 10% of the time.
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.
Salary Range: USD$159.440,00
- USD$239.160,00 Download Our Benefits Summary PDF
Not Specified
J
Senior Data Analyst
🏢 Jobot
Salary not disclosed
Senior Data Analyst Needed
- $165K-$245K
- Growing AI Firm
- Great Benefits! This Jobot Job is hosted by: Steven Zacharias Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $165,000
- $245,000 per year A bit about us: We are a growing AI powered technology firm that's looking for a seasoned Data Analyst! If interested, please apply or email me your resume directly at
- /> Why join us? $165,000-$245,000 Base Salary + Bonus Health / Dental / Vision
- 100% Paid by Employer 401k w/ Employer Match Tuition Reimbursement PTO & much more! Job Details Qualifications: Strong SQL and python skills; experience with large, event-driven datasets.
Strong working familiarity with analytical and statistical techniques for analysis, testing, and identifying casual relationships.
Familiarity with common analytics concepts (funnels, retention, cohort analysis, experiment design).
Ability to partner with PMs and engineers, and turn questions into structured analysis.
History of writing easy-to-follow code and effective documentation for your projects Experience with dbt, Hex, and experimentation platforms is a plus.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Jobot is an Equal Opportunity Employer.
We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws.
Jobot also prohibits harassment of applicants or employees based on any of these protected categories.
It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization.
Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at /legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners.
Frequency varies for text messages.
Message and data rates may apply.
Carriers are not liable for delayed or undelivered messages.
You can reply STOP to cancel and HELP for help.
You can access our privacy policy here: /privacy-policy
- $165K-$245K
- Growing AI Firm
- Great Benefits! This Jobot Job is hosted by: Steven Zacharias Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $165,000
- $245,000 per year A bit about us: We are a growing AI powered technology firm that's looking for a seasoned Data Analyst! If interested, please apply or email me your resume directly at
- /> Why join us? $165,000-$245,000 Base Salary + Bonus Health / Dental / Vision
- 100% Paid by Employer 401k w/ Employer Match Tuition Reimbursement PTO & much more! Job Details Qualifications: Strong SQL and python skills; experience with large, event-driven datasets.
Strong working familiarity with analytical and statistical techniques for analysis, testing, and identifying casual relationships.
Familiarity with common analytics concepts (funnels, retention, cohort analysis, experiment design).
Ability to partner with PMs and engineers, and turn questions into structured analysis.
History of writing easy-to-follow code and effective documentation for your projects Experience with dbt, Hex, and experimentation platforms is a plus.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Jobot is an Equal Opportunity Employer.
We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws.
Jobot also prohibits harassment of applicants or employees based on any of these protected categories.
It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization.
Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at /legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners.
Frequency varies for text messages.
Message and data rates may apply.
Carriers are not liable for delayed or undelivered messages.
You can reply STOP to cancel and HELP for help.
You can access our privacy policy here: /privacy-policy
Not Specified
D
Senior Associate SP&L
🏢 Daiichi Sankyo, Inc.
Salary not disclosed
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines.
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary This is an operational position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations.
Work is escalated if outside of scope of role, and/or complexity? This position has strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.
Has sufficient knowledge to Identify critical issues or problems with Projects and/or identification of issues which may compromise patient dosing or safety.
Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized and the need for CAPAs or reports on deviations is clearly understood.
Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address such issues or concerns.
Experience with IRT systems and support in managing the forecasting and planning of drug supply needs Able to participate effectively on a cross functional and on Global teams.
Job Description Responsibilities Works, under supervision, with outsourcing to submit appropriate requirements on a project basis.
Supports team in generating RFPs and in reviewing proposals and selecting vendors.
This position also supports the management of the WO development and implementation.
Supports packaging design and patient kit supply preparation, label generations and approvals and associated interactions with vendors.
Supports regular vendor/sponsor discussions to identify risks and ongoing study support.
Identifies critical issues which may compromise patient dosing or safety.
Supports comparator sourcing requirements, RFP generation and working with outsourcing to submit appropriate requirements on a Project basis.
Vendor Management – support interactions with Vendors on packaging design and patient kit supply preparation, label generations and approvals.
Support regular vendor/sponsor discussions to identify risks and ongoing study support.
Ensures on time site shipments for subject and patient dosing, and ensures that material is fully released prior to shipment to site Ensures compliance with all domestic and foreign regulatory requirements but may seek line management support when necessary.
Basic knowledge of Import/export requirements to the extent that there is overall recognition of potential global issues as regards import license requirements, shipment delays and is able to communicate the issues and support resolution development.
Support IRT design for control of drug dispensing and inventory management.
Understand User specifications in support of IRT processes and basic concepts of IRT Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree in Pharmacy or related field preferred PharmD preferred Master's Degree preferred Experience Qualifications 4 or More Years related experience preferred Experience in Project Management, Clinical Supply Management, and/or Clinical Trials Coordination required Demonstrated experience in working on inventory management, forecasting, and distribution of drug supply needs, IXRS experience, managing vendors and contributing to budget control preferred Additional Information 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.
Salary Range: USD$99.120,00
- USD$148.680,00 Download Our Benefits Summary PDF
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary This is an operational position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations.
Work is escalated if outside of scope of role, and/or complexity? This position has strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.
Has sufficient knowledge to Identify critical issues or problems with Projects and/or identification of issues which may compromise patient dosing or safety.
Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized and the need for CAPAs or reports on deviations is clearly understood.
Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address such issues or concerns.
Experience with IRT systems and support in managing the forecasting and planning of drug supply needs Able to participate effectively on a cross functional and on Global teams.
Job Description Responsibilities Works, under supervision, with outsourcing to submit appropriate requirements on a project basis.
Supports team in generating RFPs and in reviewing proposals and selecting vendors.
This position also supports the management of the WO development and implementation.
Supports packaging design and patient kit supply preparation, label generations and approvals and associated interactions with vendors.
Supports regular vendor/sponsor discussions to identify risks and ongoing study support.
Identifies critical issues which may compromise patient dosing or safety.
Supports comparator sourcing requirements, RFP generation and working with outsourcing to submit appropriate requirements on a Project basis.
Vendor Management – support interactions with Vendors on packaging design and patient kit supply preparation, label generations and approvals.
Support regular vendor/sponsor discussions to identify risks and ongoing study support.
Ensures on time site shipments for subject and patient dosing, and ensures that material is fully released prior to shipment to site Ensures compliance with all domestic and foreign regulatory requirements but may seek line management support when necessary.
Basic knowledge of Import/export requirements to the extent that there is overall recognition of potential global issues as regards import license requirements, shipment delays and is able to communicate the issues and support resolution development.
Support IRT design for control of drug dispensing and inventory management.
Understand User specifications in support of IRT processes and basic concepts of IRT Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree in Pharmacy or related field preferred PharmD preferred Master's Degree preferred Experience Qualifications 4 or More Years related experience preferred Experience in Project Management, Clinical Supply Management, and/or Clinical Trials Coordination required Demonstrated experience in working on inventory management, forecasting, and distribution of drug supply needs, IXRS experience, managing vendors and contributing to budget control preferred Additional Information 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.
Salary Range: USD$99.120,00
- USD$148.680,00 Download Our Benefits Summary PDF
Not Specified
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