Information Technology Jobs in Bridgewater
139 positions found — Page 11
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 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
- $16.17 per hour and is dependent upon qualifications and experience.
Benefits include: New Jersey Paid Sick Time, Contest Prize Awards, 401K Plan with Company Match, Employee Assistance Program, 30% Merchandise Discount.
All Bonuses, Awards and Benefits subject to qualifications and eligibility.
Brand: Spencer's ?The Sales Associate is responsible for maintaining Guest Services as per Company Standard.
The Sales Associate will support the Store Management Team by generating sales, conducting housekeeping, merchandising, signing, pricing, POS operations and loss prevention in adherence to all Company policies and procedures.
The minimum age requirement for this position is 17.
The physical demands of the job require climbing ladders, lifting up to 50 pounds and may require 8 hours of standing/walking.
As an equal opportunity employer, Spencer Gifts – Spirit Halloween considers applicants for all positions without regard to race, color, sex, religion, national origin, disability, age, height, weight, marital status, sexual orientation, familial status, genetic information or any other characteristic or protected classes as defined by federal, state/provincial, or local law.
Spencer Gifts – Spirit Halloween will consider for employment qualified applicants with criminal histories.
- $23.17 per hour and is dependent upon qualifications and experience.
Benefits include: Company Paid Sick Time, Paid Vacation Time, Paid Holidays, Bereavement Pay, Jury Duty Pay, Monthly Sales Bonus, Yearly Shrink Bonus, Champions Club Bonus, Contest Prize Awards, 401K Plan with Company Match, Medical/Dental/Vision Plans, Employee Assistance Program, 30% Discount Merchandise, College Scholarship Award.
All Bonuses, Awards and Benefits subject to qualifications and eligibility.
Brand: Spencer's The Store Manager is responsible for establishing and maintaining Guest Services.
The Store Manager oversees and is accountable for the operation of a store, ensuring maximum sales and profitability through controlling expenses, shrinkage, human resources management as well as all aspects of merchandising and inventory control in adherence with all Company policies and procedures.
The minimum age requirement for a Store Manager is 21.
The physical demands of the job require in excess of 8 hours of standing, walking, climbing ladders and lifting up to 50 pounds.
Prior retail management experience is required.
As an equal opportunity employer, Spencer Gifts – Spirit Halloween considers applicants for all positions without regard to race, color, sex, religion, national origin, disability, age, height, weight, marital status, sexual orientation, familial status, genetic information or any other characteristic or protected classes as defined by federal, state/provincial, or local law.
Spencer Gifts – Spirit Halloween will consider for employment qualified applicants with criminal histories.
- $20.17 per hour and is dependent upon qualifications and experience.
Benefits include: Company Paid Sick Time, Paid Vacation Time, Paid Holidays, Bereavement Pay, Jury Duty Pay, Contest Prize Awards, 401K Plan with Company Match, Medical/Dental/Vision Plans, Employee Assistance Program, 30% Merchandise Discount, College Scholarship Award.
All Bonuses, Awards and Benefits subject to qualifications and eligibility.
The Assistant Store Manager is responsible for establishing and maintaining Guest Services.
The Assistant Manager is responsible for supporting the Store Manager in the various tasks involved in the overall operation of a store, ensuring maximum sales and profitability by developing staff, controlling expenses and shrinkage as well as all aspects of merchandising and inventory control in adherence with all Company policies and procedures.
This position will work up to 38 hours per week.
The minimum age requirement for an Assistant Store Manager is 18.
The physical demands of the job require in excess of 8 hours of standing, walking, climbing ladders and lifting up to 50 pounds.
Prior retail and or management experience is required.
As an equal opportunity employer, Spencer Gifts – Spirit Halloween considers applicants for all positions without regard to race, color, sex, religion, national origin, disability, age, height, weight, marital status, sexual orientation, familial status, genetic information or any other characteristic or protected classes as defined by federal, state/provincial, or local law.
Spencer Gifts – Spirit Halloween will consider for employment qualified applicants with criminal histories.
- $18.17 per hour and is dependent upon qualifications and experience.
Benefits include: Company Paid Sick Time, Paid Vacation Time, Paid Holidays, Bereavement Pay, Jury Duty Pay, Contest Prize Awards, 401K Plan with Company Match, Medical/Dental/Vision Plans, Employee Assistance Program, 30% Merchandise Discount, College Scholarship Award.
All Bonuses, Awards and Benefits subject to qualifications and eligibility.
Brand: Spencer's The Assistant Store Manager is responsible for establishing and maintaining Guest Services.
The Assistant Manager is responsible for supporting the Store Manager in the various tasks involved in the overall operation of a store, ensuring maximum sales and profitability by developing staff, controlling expenses and shrinkage as well as all aspects of merchandising and inventory control in adherence with all Company policies and procedures.
The minimum age requirement for an Assistant Store Manager is 18.
The physical demands of the job require in excess of 8 hours of standing, walking, climbing ladders and lifting up to 50 pounds.
Prior retail and or management experience is required.
As an equal opportunity employer, Spencer Gifts – Spirit Halloween considers applicants for all positions without regard to race, color, sex, religion, national origin, disability, age, height, weight, marital status, sexual orientation, familial status, genetic information or any other characteristic or protected classes as defined by federal, state/provincial, or local law.
Spencer Gifts – Spirit Halloween will consider for employment qualified applicants with criminal histories.
We’re seeking proactive and independent individuals interested in learning how to earn money online. This opportunity is ideal for those who want a self-directed, flexible way to build extra income.
You’ll receive full access to information and resources that explain tested earning methods and how to manage them efficiently.
Responsibilities:
Complete introductory learning materials
Apply recommended online income methods
Track results and refine your approach over time
Stay consistent and goal-focused
Requirements:
A laptop or smartphone with internet access
Ability to follow instructions independently
Good communication and organisation
Motivation to take initiative
Benefits:
Fully remote
No fixed hours or contracts
Flexible entry-level opportunity
Support materials provided
Remote working/work at home options are available for this role.
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 Participate in the implementation of the quality strategy closely aligned with the business strategy within the CSPV function.
Provide strategic and proactive QA Leadership and support development Project Teams and CSPV with adequate quality and compliance guidance in close alignment with the Head of Global PV QA Americas.
Including, daily consultation to CSPV unit to harmonize end to end "proactive quality".
Advise development teams in quality and compliance decision making to drive sustainable quality and compliance excellence.
Provide quality and compliance guidance for process deviations and implementation of corrective and preventive actions, including enhanced involvement on Root Cause Analysis (RCA); monitor their status and timely closure.
Support risk management activities, including trend analysis KQIs (e.g.
Audits, Inspections, QIs including late ICSR submission of reports, and their CAPAs, etc.) from a PV Quality perspective.
Ensure adequate regulatory inspection and audits preparation.
Responsible for the coordination and support CSPV for preparation.
Participates in PV inspections/Audits.
Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all CSPV matters for the Project Teams and CSPV.
Provide operational QA leadership for the respective CSPV teams, including Quality Oversight for the Quality Plan execution, review of key CSPV regulatory documents, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective CSPV functional areas.
Responsibilities Facilitate the implementation of the quality strategy in close alignment with the CSPV business strategy.
Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan together with the supported CSPV teams, including the quality risk assessments and inspection readiness components for the designated programs.
Ensure proactive representation of Quality professionals at strategic non-project team and at CSPV strategic discussions.
Participate in the development and/or enhancement of CSPV Strategy and PV/GxP QA business processes, procedures, and best practices.
Support the Head of PV QA, Americas with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs).
Interact with senior CSPV leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process.
Interact with the audit function.
The respective CSPV groups and respective CROs, Partners and Affiliates in order to ensure high data quality and proactive detection and resolution of issues.
Actively participate in special assignments on various project teams and work streams as determined by QA management.
Effectively communicate with CSPV, by interacting with other GxP QA functions (R&D Quality, GMP/ IMP QA, Audit, Quality Standards and Procedures QA and in close collaboration with CAPA Manager.), on CSPV topics/issues impacting the respective Pharmacovigilance operations and safety activities.
Collaborate with CSPV and Global PV Quality on quality review of PV and REMS documents, including SOPs, Pharmacovigilance Site Master File (PSMF) audit content, and REMS material.
Help to ensure in collaboration with CSPV or other business process owners that applicable CSPV processes and quality standards which are in line with worldwide HA requirements are implemented.
Help to establish in built controls in relevant process steps to ensure adherence to regulatory compliance.
Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to Daiichi Sankyo’s policies and practices to maintain proactive compliance.
Quality Oversight: a.
Ensure adequate and timely escalation of incidents/issues within CSPV and QA.
Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course.
b.
In collaboration with GxP Quality Systems and Compliance provide Quality oversight for deviations/incidents & investigations and ensure that adequate CAPAs are defined, implemented and their closure tracked.
Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA).
Coordinate and review CAPAs to audits to ensure adequate root cause analysis and systemic solutions.
c.
Ensure that proper Quality oversight is implemented for 3rd parties/vendors/outsourced activities.
In collaboration with CSPV develop Lessons learned information flow at the CSPV operational level based on audits, inspections, regulatory intelligence, effectiveness checks and process improvement.
Ensure continued submission and inspection readiness for the respective CSPV team and related submissions.
Facilitate respective regulatory inspection preparation, management and follow-up in collaboration with CSPV.
Support local inspections with adequate systems and process support.
Qualifications Education Qualifications Bachelor's Degree in Life Sciences, Pharmacy or Medicines required and Master's Degree or other advanced degree preferred.
Experience Qualifications 7 or more years of involvement in regulated activities, clinical development, PV and QA (preferably) or equivalent experience required Must have a broad understanding of global expectations of Health Authorities in the conduct of clinical trials required Proven ability understanding the phamaceutical product development process required Must have extensive knowledge of international GvP (required) GCP (preferred) regulations including FDA,EMA and ICH Travel Requirements Ability to travel up to 20% of the time.
Ability to travel 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$150.800,00
- USD$226.200,00 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 Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi Sankyo's GxP group.
Together with regional management teams plans, supports, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP audits assigned.
Responsibilities Execute the audit program for internal systems as applicable for the area of GxP audits assigned in alignment with the Master Audit Schedule using a risk-based approach to ensure the Audit Plans are aligned with the company’s strategy and objectives and adjust the plan as needed to support business functions and internal stakeholders to execute audits effectively.
Ensure trending and signal detection is communicated to stakeholders for risk mitigation.
Support the stakeholders in identifying and defining quality improvement initiatives for development activities / programs post internal system audit.
Support reporting of quality metrics for audits and inspections and execute against these metrics consistently.
Provide inspection management support regarding compliance concerns identified during internal systems audits, remediations implemented and CAPAs pending.
Support Risk Mitigation programs to ensure compliance to regulatory guidelines.
Ensure up to date audit CAPA information in the eQMS in a timely manner.
Collaborate with QMS Team and applicable QA function to ensure no overdue CAPAs.
Qualifications Education Qualifications Bachelor's Degree in a scientific, healthcare or related discipline required Experience Qualifications 4 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance Must have strong proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials.
Ability to provide interpretation and guidance for internal and external customers on GxP related regulations / guidelines (e.g., FDA, EU, ICH) and company procedures and policies.
Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products strongly preferred Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies) International experience is a plus; but at minimum, experience working with diverse cultures and employees is required Demonstrated expertise working within early development through Phase III and Pharmacovigilance studies Travel Requirements Ability to travel up to 10% of the time.
15% domestic and international travel 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$116.400,00
- USD$174.600,00 Download Our Benefits Summary PDF