Engineering Structures Elsevier Jobs in Manville, NJ
65 positions found — Page 7
D
Manager, PV Quality Management
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 position supports the Associate Director, PV Quality & Compliance, PV Quality Management in the establishment, implementation, and oversight of the CSPV Quality, Compliance and Training function.
This position is responsible for managing activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance reports relative to safety reporting processes and regulatory authority submissions.
This role is the primary CSPV contact for Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections conducted by global Health Authorities/Regulatory Authorities (HAs/RAs) and PV audits conducted by DS Quality Assurance and License Partners/Affiliates, as applicable.
This position is responsible for facilitating audit and inspection-related activities within CSPV and supports the development of inspection readiness initiatives.
This position is responsibility for identifying training needs for CSPV staff and developing and overseeing training to ensure awareness of and compliance with organizational objectives and global laws and regulatory requirements.
With support from the Associate Director, PV Quality & Compliance, PV Quality Management, this position will take a lead role in the design, development, and coordination of training programs based on corporate, organizational and individual needs, collaborating with CSPV management and cross-functionally to ensure training needs are met.
This position is responsible for the design and development of a procedural document management program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
This position liaises with CSPV management and cross-functional teams as necessary throughout the corporation to drive a culture of regulatory compliance and ensure effective and efficient management of CSPV activities.
Job Description Responsibilities Quality and Compliance: Manages activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance metrics reports relative to the safety reporting and regulatory submission of individual case safety reports (ICSRs) and aggregate periodic safety reports.
Drives and manages an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis, root cause analysis and implementation of process improvement measures and effectiveness checks.
Leads audit/inspection readiness activities including but not limited to conducting routine/periodic quality assurance assessments to measure and ensure adherence of CSPV processes and procedures by internal personnel and external vendors.
Support conduct of inspections and audits and closely collaborate with Global GCP/PV-QA audit department in preparation of internal audits and regulatory inspections including preparation, review and provision of relevant documents; assigning roles and responsibilities for each audit/inspection.
Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures.
Collaborates with members of inspection team and other colleagues including Quality Assurance to ensure optimum responses to audit/inspection findings.
Responsibilities Continued Training Program: Takes a lead role in the development and enhancement of CSPV training programs based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training.
Training Plan and Delivery: Mentors instructors, subject matter experts and supervisors in techniques and skills for conducting effective training for staff, as needed.
Oversees the quality and consistency of training conducted within CSPV.
Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training.
Resolves and responds to training issues and questions.
Training Records and Maintenance: Monitors training compliance, and coordinates escalation of non-compliance.
Works with LMS Administrator to generate/access necessary training reports and to ensure proper training documentation.
Responsible for the implementation and maintenance of the Global Training Matrix for CSPV and leading related process improvements, as necessary.
Supports the annual roll-out of the Adverse Event Reporting Policy Training assigned to all company staff globally, which includes project management, facilitation of updates to the training content, evaluation of training adequacy, and appropriate distribution of training (with technical support from the LMS Administrator for LMS assignments).
Ensures training processes and relevant materials are up-to-date.
May participate in creation, review, and revisions to controlled documents and procedures.
Procedural Document Management: Procedural Document Program: Takes a lead role in the development and enhancement of a procedural and standards program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
Drives the strategic direction for documentation control including retirement schedules, file structures, delivery mechanisms (instructional, LMS, etc.).
Coordinates training curriculum for each function within CSPV and ensures the appropriate documentation is contained within the training profile.
Procedural Document Development and Delivery: Takes a lead role in the development of CSPV-related policies, procedures, operating guidelines including but not limited to SOPs, SOIs, guidance documents, associated forms and templates).
Works closely with CSPV management, SMEs and other functions as applicable to develop SOPs, SOIs and Guidance Documents.
Strives to ensure the process is optimized for efficiency and clarity.
Supports process redesign initiatives by updating relevant documentation for changes to processes.
Procedural Document Records and Maintenance: Maintains all documentation files, including forms and templates and communicates updates/revisions to documents.
Responsible for inspection readiness activities related to documentation.
Supports all internal and external partner audits for documentation requirements.
Qualifications Education Qualifications Bachelor's Degree, preferably in healthcare or life sciences, required Master's Degree, PharmD, RN preferred Experience Qualifications 4+ years of Pharmacovigilance experience in a pharmaceutical, biotechnology or related environment required.
7+ years total pharmaceutical industry experience in one or more of the following areas: Drug Safety/Pharmacovigilance, Epidemiology, and Clinical Development preferred 4+ years of direct experience in Pharmacovigilance Compliance, global setting preferred Possesses strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines preferred 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$124.960,00
- USD$187.440,00 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 position supports the Associate Director, PV Quality & Compliance, PV Quality Management in the establishment, implementation, and oversight of the CSPV Quality, Compliance and Training function.
This position is responsible for managing activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance reports relative to safety reporting processes and regulatory authority submissions.
This role is the primary CSPV contact for Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections conducted by global Health Authorities/Regulatory Authorities (HAs/RAs) and PV audits conducted by DS Quality Assurance and License Partners/Affiliates, as applicable.
This position is responsible for facilitating audit and inspection-related activities within CSPV and supports the development of inspection readiness initiatives.
This position is responsibility for identifying training needs for CSPV staff and developing and overseeing training to ensure awareness of and compliance with organizational objectives and global laws and regulatory requirements.
With support from the Associate Director, PV Quality & Compliance, PV Quality Management, this position will take a lead role in the design, development, and coordination of training programs based on corporate, organizational and individual needs, collaborating with CSPV management and cross-functionally to ensure training needs are met.
This position is responsible for the design and development of a procedural document management program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
This position liaises with CSPV management and cross-functional teams as necessary throughout the corporation to drive a culture of regulatory compliance and ensure effective and efficient management of CSPV activities.
Job Description Responsibilities Quality and Compliance: Manages activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance metrics reports relative to the safety reporting and regulatory submission of individual case safety reports (ICSRs) and aggregate periodic safety reports.
Drives and manages an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis, root cause analysis and implementation of process improvement measures and effectiveness checks.
Leads audit/inspection readiness activities including but not limited to conducting routine/periodic quality assurance assessments to measure and ensure adherence of CSPV processes and procedures by internal personnel and external vendors.
Support conduct of inspections and audits and closely collaborate with Global GCP/PV-QA audit department in preparation of internal audits and regulatory inspections including preparation, review and provision of relevant documents; assigning roles and responsibilities for each audit/inspection.
Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures.
Collaborates with members of inspection team and other colleagues including Quality Assurance to ensure optimum responses to audit/inspection findings.
Responsibilities Continued Training Program: Takes a lead role in the development and enhancement of CSPV training programs based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training.
Training Plan and Delivery: Mentors instructors, subject matter experts and supervisors in techniques and skills for conducting effective training for staff, as needed.
Oversees the quality and consistency of training conducted within CSPV.
Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training.
Resolves and responds to training issues and questions.
Training Records and Maintenance: Monitors training compliance, and coordinates escalation of non-compliance.
Works with LMS Administrator to generate/access necessary training reports and to ensure proper training documentation.
Responsible for the implementation and maintenance of the Global Training Matrix for CSPV and leading related process improvements, as necessary.
Supports the annual roll-out of the Adverse Event Reporting Policy Training assigned to all company staff globally, which includes project management, facilitation of updates to the training content, evaluation of training adequacy, and appropriate distribution of training (with technical support from the LMS Administrator for LMS assignments).
Ensures training processes and relevant materials are up-to-date.
May participate in creation, review, and revisions to controlled documents and procedures.
Procedural Document Management: Procedural Document Program: Takes a lead role in the development and enhancement of a procedural and standards program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
Drives the strategic direction for documentation control including retirement schedules, file structures, delivery mechanisms (instructional, LMS, etc.).
Coordinates training curriculum for each function within CSPV and ensures the appropriate documentation is contained within the training profile.
Procedural Document Development and Delivery: Takes a lead role in the development of CSPV-related policies, procedures, operating guidelines including but not limited to SOPs, SOIs, guidance documents, associated forms and templates).
Works closely with CSPV management, SMEs and other functions as applicable to develop SOPs, SOIs and Guidance Documents.
Strives to ensure the process is optimized for efficiency and clarity.
Supports process redesign initiatives by updating relevant documentation for changes to processes.
Procedural Document Records and Maintenance: Maintains all documentation files, including forms and templates and communicates updates/revisions to documents.
Responsible for inspection readiness activities related to documentation.
Supports all internal and external partner audits for documentation requirements.
Qualifications Education Qualifications Bachelor's Degree, preferably in healthcare or life sciences, required Master's Degree, PharmD, RN preferred Experience Qualifications 4+ years of Pharmacovigilance experience in a pharmaceutical, biotechnology or related environment required.
7+ years total pharmaceutical industry experience in one or more of the following areas: Drug Safety/Pharmacovigilance, Epidemiology, and Clinical Development preferred 4+ years of direct experience in Pharmacovigilance Compliance, global setting preferred Possesses strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines preferred 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$124.960,00
- USD$187.440,00 Download Our Benefits Summary PDF
Not Specified
J
VP of Operations
🏢 Jobot
Salary not disclosed
VP of Operations Needed For Leading Contract Manufacturing Company 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: $160,000
- $200,000 per year A bit about us: My client is a leading contract manufacturing company who is looking to add a VP of Operations to the team.
This person will be key in leading manufacturing, logistics, planning, supply chain, and continuous improvement activities throughout the plant.
Why join us? Compensation up to $200,000 + 30% Bonus Job Details Key Responsibilities: Oversee day-to-day manufacturing operations across multiple departments.
Lead process improvement initiatives to enhance productivity, quality, and cost-effectiveness.
Manage relationships with contract manufacturing partners to ensure performance and quality standards.
Collaborate cross-functionally with leadership in engineering, supply chain, quality, and finance.
Ensure alignment of production plans with business goals and customer requirements.
Provide leadership and direction to departmental managers and their teams.
Track and report key operational metrics to executive leadership.
Qualifications: Bachelor’s degree in Engineering, Operations, or related field; advanced degree preferred.
10+ years of manufacturing leadership experience, including multi-department oversight.
Strong background in metals manufacturing; metal stamping experience is a plus.
Experience with contract manufacturing and supply chain coordination.
Proven ability to lead process improvements and operational efficiency initiatives.
Excellent leadership, communication, and strategic planning skills.
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: $160,000
- $200,000 per year A bit about us: My client is a leading contract manufacturing company who is looking to add a VP of Operations to the team.
This person will be key in leading manufacturing, logistics, planning, supply chain, and continuous improvement activities throughout the plant.
Why join us? Compensation up to $200,000 + 30% Bonus Job Details Key Responsibilities: Oversee day-to-day manufacturing operations across multiple departments.
Lead process improvement initiatives to enhance productivity, quality, and cost-effectiveness.
Manage relationships with contract manufacturing partners to ensure performance and quality standards.
Collaborate cross-functionally with leadership in engineering, supply chain, quality, and finance.
Ensure alignment of production plans with business goals and customer requirements.
Provide leadership and direction to departmental managers and their teams.
Track and report key operational metrics to executive leadership.
Qualifications: Bachelor’s degree in Engineering, Operations, or related field; advanced degree preferred.
10+ years of manufacturing leadership experience, including multi-department oversight.
Strong background in metals manufacturing; metal stamping experience is a plus.
Experience with contract manufacturing and supply chain coordination.
Proven ability to lead process improvements and operational efficiency initiatives.
Excellent leadership, communication, and strategic planning skills.
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
🏢 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 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
T
CDL Driver
🏢 Turtle
Salary not disclosed
Title: CDL Driver Location: Somerset, NJ Type: Full
- Time Shift: Monday
- Friday 4 am start Why Turtle? At Turtle, we’re redefining what it means to be an industry leader in electrical distribution, and we want you to be part of our exciting journey! For over 100 years, we’ve built a reputation for innovation, excellence, and exceptional customer service—and we’re just getting started.
We are a diverse, passionate team spread across the US, Canada, Mexico, and Puerto Rico, committed to growth, learning, and creating opportunities for each other.
At Turtle, every day is a chance to make a real difference, solve complex challenges, and push the boundaries of what’s possible.
We believe in fostering an environment that inspires collaboration and sparks creativity, where employees are empowered to contribute to our mission and shape the future of the industry.
If you're looking for a fast-paced, dynamic career where your ideas are valued and your growth is prioritized, Turtle is the place for you.
Join us and be a part of a company that’s making waves and empowering its people to do extraordinary things every single day! About the Role The Driver will be responsible for driving a company vehicle throughout the assigned geographic area and ensure safety of self and others while driving.
What You'll Do Load/unload cargo Execute local deliveries and obtain authorization signatures Ensure the receipt, coordination, and safety of goods coming through the warehouse Ensure products are stocked correctly and safely What You'll Bring High School Diploma or equivalent Valid CDL Class A or B license required.
Class A preferred.
Minimum 1 Year Driving Experience Valid Driver's License with clean driving record Ability to climb and lift minimum 25lbs What We Offer We offer a competitive benefits package that includes: 401(k) plan Health insurance Dental insurance Vision insurance Life insurance Paid holidays Vacation Employee negotiated discounts Who We Are Founded in 1923, Turtle is a fourth-generation, family-owned, and three-generation women-owned business, and one of the nation’s largest independent electrical and industrial distributors.
Headquartered in Clark, NJ, our Electrical Distribution division operates 14 branches spanning from coast to coast.
It is a significant force in the engineering and procurement of power distribution, automation, lighting, and energy projects, offering integrated services for the industrial and construction markets.
Turtle Integrated provides on-site MRO procurement, cost-saving, and spend analytics across the US and in Canada, Puerto Rico, and Mexico.
What To Do Next You can begin by filling out our application online.
If you want to learn more about Turtle, please visit our website or our LinkedIn: @Turtle.
Turtle is proud to be is an equal opportunity employer that is committed to diversity and inclusion in the workplace.
We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, gender identity or expression, national origin, disability, genetic information, pregnancy, marital status, military or veteran status, or any other protected characteristic as outlined by federal, state, or local laws.
- Time Shift: Monday
- Friday 4 am start Why Turtle? At Turtle, we’re redefining what it means to be an industry leader in electrical distribution, and we want you to be part of our exciting journey! For over 100 years, we’ve built a reputation for innovation, excellence, and exceptional customer service—and we’re just getting started.
We are a diverse, passionate team spread across the US, Canada, Mexico, and Puerto Rico, committed to growth, learning, and creating opportunities for each other.
At Turtle, every day is a chance to make a real difference, solve complex challenges, and push the boundaries of what’s possible.
We believe in fostering an environment that inspires collaboration and sparks creativity, where employees are empowered to contribute to our mission and shape the future of the industry.
If you're looking for a fast-paced, dynamic career where your ideas are valued and your growth is prioritized, Turtle is the place for you.
Join us and be a part of a company that’s making waves and empowering its people to do extraordinary things every single day! About the Role The Driver will be responsible for driving a company vehicle throughout the assigned geographic area and ensure safety of self and others while driving.
What You'll Do Load/unload cargo Execute local deliveries and obtain authorization signatures Ensure the receipt, coordination, and safety of goods coming through the warehouse Ensure products are stocked correctly and safely What You'll Bring High School Diploma or equivalent Valid CDL Class A or B license required.
Class A preferred.
Minimum 1 Year Driving Experience Valid Driver's License with clean driving record Ability to climb and lift minimum 25lbs What We Offer We offer a competitive benefits package that includes: 401(k) plan Health insurance Dental insurance Vision insurance Life insurance Paid holidays Vacation Employee negotiated discounts Who We Are Founded in 1923, Turtle is a fourth-generation, family-owned, and three-generation women-owned business, and one of the nation’s largest independent electrical and industrial distributors.
Headquartered in Clark, NJ, our Electrical Distribution division operates 14 branches spanning from coast to coast.
It is a significant force in the engineering and procurement of power distribution, automation, lighting, and energy projects, offering integrated services for the industrial and construction markets.
Turtle Integrated provides on-site MRO procurement, cost-saving, and spend analytics across the US and in Canada, Puerto Rico, and Mexico.
What To Do Next You can begin by filling out our application online.
If you want to learn more about Turtle, please visit our website or our LinkedIn: @Turtle.
Turtle is proud to be is an equal opportunity employer that is committed to diversity and inclusion in the workplace.
We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, gender identity or expression, national origin, disability, genetic information, pregnancy, marital status, military or veteran status, or any other protected characteristic as outlined by federal, state, or local laws.
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
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