Information Technology Jobs in Basking Ridge
195 positions found — Page 16
D
Senior Director, Clinical Safety MD
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 Senior Director, Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework.
This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites.
The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug.
Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).
Job Description Responsibilities Responsibilities: • Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
• Effectively represent the CSPV on the Global Product Team or other cross-functional teams providing the safety leadership and serving as the primary point of contact.
• Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals.
• Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.
• Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.
• Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time.
• Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).
Responsibilities Continued Qualifications Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university) • An MD is required (board certification or eligibility) Experience Qualifications: • 6 or more years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.
• Expertise in oncology highly preferred.
Travel: Some travel both domestic and global will be required.
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$275.250,00
- USD$458.750,00 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 Senior Director, Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework.
This individual will use strong leadership and communication skills to successfully coordinate resources and ensure effective collaboration across development functions and sites.
The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug.
Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization).
Job Description Responsibilities Responsibilities: • Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
• Effectively represent the CSPV on the Global Product Team or other cross-functional teams providing the safety leadership and serving as the primary point of contact.
• Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals.
• Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.
• Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.
• Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time.
• Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).
Responsibilities Continued Qualifications Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university) • An MD is required (board certification or eligibility) Experience Qualifications: • 6 or more years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.
• Expertise in oncology highly preferred.
Travel: Some travel both domestic and global will be required.
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$275.250,00
- USD$458.750,00 Download Our Benefits Summary PDF
Not Specified
D
Clinical Study Manager
🏢 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 Clinical Study Manager is responsible for the delivery and execution of global clinical studies under the direction of a Study Delivery Lead.
This role is primarily focused on tactical study delivery and reports to a Director or higher-level position.
The position requires excellent written and verbal communication, project management skills, and attention to detail.
The Clinical Study Manager will have routine interaction with key internal and external stakeholders to communicate project status, resolve issues, and troubleshoot routine inquiries.
This position may require the Clinical Study Manager to take on a dual role of both operational strategy and study execution.
Job Description Responsibilities Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
In a CRO outsourcing model, responsibilities also include: Study Oversight: Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials.
May provide support as back-up to the Study Delivery Lead as needed.
Cross-Functional Leadership: Participate and provide expertise as a cross-functional study team member, including vendors, and liaise with other departments.
Provide mentorship of more junior Operations team members.
Vendor Management: Lead vendor selection, contracting, and management to maintain study quality and compliance and adherence to scope of work within timelines and budget.
Oversee complex vendors (i.e., eCOA).
CRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level.
Coordinate and develop materials for CRO KOMs and Investigator meetings.
Compliance and Regulatory: Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.).
Timeline and Budget Management: Create and coordinate clinical study timelines and budgets with Global Project Management and R&D Finance to meet critical milestones and manage budgets.
Responsible for continual review of study timelines and study budget.
Risk Management: Identify, mitigate, and escalate risks per process throughout the study lifecycle.
Ensure risks are appropriately logged in the risk management system.
Study Material Development: Co-develop and manage study materials, including training materials, protocols, CRFs, and study operational plans.
Ensure all necessary operational materials are in place.
Data Cleaning: Oversee site and monitor data cleaning metrics including EDC data entry, query resolution timeliness, and protocol deviation review.
Site Management: Oversee site selection, start-up, monitoring, and closeout for the trial.
Study Communication: Triage, resolve or escalate study issues /risk mitigations to the Study Delivery Lead.
Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).).
oSupports risk Management initiatives oSupports audit/inspection activities as needed oEnsures trial master file is complete and accurate for assigned stud(ies) Communication and Reporting: Provide regular updates on study progress to key stakeholders.
Training: Identify training needs for key stakeholders as needed, e.g., study team members, vendors and ensure training is carried out.
Develop training materials as necessary.
Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree preferred in Life Sciences required Experience Qualifications 3 or more years required and Relevant experience is required with a BSc required and Experience in oversight of global clinical trials (all phases) in all stages of delivery with requisite industry training and experience required and Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO).
preferred CRA experience preferred Time spent directly in a medical environment (e.g.
as a Study Site Coordinator) preferred Familiarity to a Japan-based organization preferred Travel Requirements Ability to travel up to 10% of the time.
In-house office position that may require occasional travel (domestic or global).
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$133.600,00
- USD$200.400,00 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 Clinical Study Manager is responsible for the delivery and execution of global clinical studies under the direction of a Study Delivery Lead.
This role is primarily focused on tactical study delivery and reports to a Director or higher-level position.
The position requires excellent written and verbal communication, project management skills, and attention to detail.
The Clinical Study Manager will have routine interaction with key internal and external stakeholders to communicate project status, resolve issues, and troubleshoot routine inquiries.
This position may require the Clinical Study Manager to take on a dual role of both operational strategy and study execution.
Job Description Responsibilities Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
In a CRO outsourcing model, responsibilities also include: Study Oversight: Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials.
May provide support as back-up to the Study Delivery Lead as needed.
Cross-Functional Leadership: Participate and provide expertise as a cross-functional study team member, including vendors, and liaise with other departments.
Provide mentorship of more junior Operations team members.
Vendor Management: Lead vendor selection, contracting, and management to maintain study quality and compliance and adherence to scope of work within timelines and budget.
Oversee complex vendors (i.e., eCOA).
CRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level.
Coordinate and develop materials for CRO KOMs and Investigator meetings.
Compliance and Regulatory: Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.).
Timeline and Budget Management: Create and coordinate clinical study timelines and budgets with Global Project Management and R&D Finance to meet critical milestones and manage budgets.
Responsible for continual review of study timelines and study budget.
Risk Management: Identify, mitigate, and escalate risks per process throughout the study lifecycle.
Ensure risks are appropriately logged in the risk management system.
Study Material Development: Co-develop and manage study materials, including training materials, protocols, CRFs, and study operational plans.
Ensure all necessary operational materials are in place.
Data Cleaning: Oversee site and monitor data cleaning metrics including EDC data entry, query resolution timeliness, and protocol deviation review.
Site Management: Oversee site selection, start-up, monitoring, and closeout for the trial.
Study Communication: Triage, resolve or escalate study issues /risk mitigations to the Study Delivery Lead.
Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).).
oSupports risk Management initiatives oSupports audit/inspection activities as needed oEnsures trial master file is complete and accurate for assigned stud(ies) Communication and Reporting: Provide regular updates on study progress to key stakeholders.
Training: Identify training needs for key stakeholders as needed, e.g., study team members, vendors and ensure training is carried out.
Develop training materials as necessary.
Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree preferred in Life Sciences required Experience Qualifications 3 or more years required and Relevant experience is required with a BSc required and Experience in oversight of global clinical trials (all phases) in all stages of delivery with requisite industry training and experience required and Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO).
preferred CRA experience preferred Time spent directly in a medical environment (e.g.
as a Study Site Coordinator) preferred Familiarity to a Japan-based organization preferred Travel Requirements Ability to travel up to 10% of the time.
In-house office position that may require occasional travel (domestic or global).
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$133.600,00
- USD$200.400,00 Download Our Benefits Summary PDF
Not Specified
Managing Counsel
Salary not disclosed
Our client – a NJ-headquartered family office focused on the development and management of millions of square feet of industrial, commercial, and residential properties and land development sites nationwide – is seeking to hire its first in-house lawyer. This newly created role will serve as the company's de facto Head of Legal and primary legal advisor across the organization. The ideal candidate is a pragmatic, business-minded attorney with at least five years of experience handling real estate matters, including leasing, financing, and land use and zoning issues, and with working familiarity in areas such as taxation, corporate governance, and employment law. Given the breadth of the remit, this role is particularly well suited to a strong generalist with prior in-house experience or a law firm attorney ready to take on broader ownership and responsibility. The successful candidate will lead the legal function and work closely with the company's President, senior leadership, and operating teams, while also managing relationships with outside counsel, lenders, joint-venture partners, and other counterparties. The organization offers a highly collaborative culture, meaningful autonomy, strong work-life balance, and long-term stability.
• Base salary of $150K – 250K depending on experience, plus eligibility for discretionary cash bonus.
Responsibilities:
• Draft, review, and negotiate commercial and other real estate leases;
• Oversee land use matters, including zoning, site planning, and related regulatory and political considerations;
• Support real estate financing transactions and assist in developing and refining the company's debt and capital strategies;
• Advise on taxation matters, including issues involving U.S. owners of foreign corporations, in coordination with external tax advisors;
• Serve as a legal liaison between U.S. headquarters and the management of a European holding company;
• Partner with the controller and financial leadership to assess legal and business risk and develop mitigation strategies;
• Handle corporate governance matters, including entity management, regulatory filings, and ongoing compliance;
• Provide legal guidance to an affiliated charitable foundation on nonprofit governance and compliance matters;
• Support select corporate, transactional, and commercial agreements outside of core real estate work;
• Assist with employment, HR, and litigation matters as needed, primarily through oversight and coordination with outside counsel;
• Manage relationships with external counsel and collaborate with cross-functional teams on legal and business initiatives; and
• Advise on day-to-day operational and strategic matters as they arise.
Required Qualifications:
• J.D. from a top-tier law school;
• Licensed and in good standing with at least one U.S. state bar;
• At least five years of relevant experience, ideally gained at a top law firm and/or a sophisticated in-house legal department (prior in-house experience strongly preferred);
• Strong working knowledge of real estate law, particularly leasing, land use and zoning, and financing (borrower-side experience preferred);
• Demonstrated experience drafting and negotiating lease agreements;
• Working familiarity with U.S. tax law and comfort collaborating with specialist advisors;
• Experience representing family offices or closely held businesses is a plus;
• Excellent judgment and communication skills, with the ability to translate legal issues into practical, business-oriented advice; and
• Strong organizational and interpersonal skills, with the ability to manage multiple priorities in a dynamic environment.
The Solomon Page Distinction
Our teams, comprised of subject matter experts, develop an interest in your preferences and goals and we act as an advisor for your career advancement. Solomon Page has an extensive network of established clients which allows us to present opportunities that are well-suited to your respective goals and needs – this specialized approach sets us apart in the industries we serve.
About Solomon Page
Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture. Acting as a strategic partner to our clients and candidates, we focus on providing customized solutions and building long-term relationships based on trust, respect, and the consistent delivery of excellent results. For more information and additional opportunities, visit: and connect with us on Facebook, and LinkedIn.
Opportunity Awaits.
Not Specified
M
Associate Attorney
Salary not disclosed
Margolis Edelstein is seeking Associate Attorneys to join our premier insurance defense law firm. The position is located in the Berkeley Heights office.
We are looking for ambitious attorneys ready to engage with clients, insurance carriers, and the court. This role offers autonomy, professional development, and the opportunity to flourish under the wing of seasoned mentors. You’ll be immersed in a team-oriented atmosphere while gaining substantial litigation experience.
We welcome candidates with a minimum of one year of experience and a valid license in the applicable state. If you are ready to step into a role where your growth is our priority, and your impact is tangible, our hiring team would like to explore your potential contribution to our firm's success.
Roles & Responsibilities
- Analyze complex legal and factual issues, conduct extensive, well-reasoned legal research, and independently develop and present defense strategies on behalf of clients.
- Prepare complex pleadings, written discovery, depositions (expert/fact/de bene esse), motions, and briefs in support of defense strategies.
- Provide effective and timely communications, information, legal advice, and other services to clients and claims personnel on legal and factual issues.
- Communicate with the court, witnesses, opposing counsel, and co-counsel in a manner consistent with established office procedures.
- Responsible for the prompt, efficient, and effective disposition of assigned cases.
- Prepare and present witnesses and evidence at trials, judicial and administrative hearings, arbitrations, and alternative dispute resolutions.
Qualifications
- J.D. and admission to the bar of the state in which you are seeking a position (admission in other states, such as PA, DE, or WV is a plus)
- Minimum 1 year of experience in insurance defense or related setting
- Litigation experience required (e.g., taking and defending depositions, preparation and filing of discovery and related motions, oral argument experience, etc.)
- Strong writing skills
- Strong attention to detail
- Excellent work ethic
Benefits
Margolis Edelstein offers a generous benefits package along with compensation based on experience. All new associates are eligible for potential salary increases 3 times during their first year, at the 4-month, 8-month, and 12-month mark. After completing their first year with the firm, associates are eligible for aggressive bonus incentives based on performance.
The firm identifies and rewards great work with a clear path to leadership and partnership. The firm also offers flexible work schedules.
Please submit your resume. A writing sample and/or transcript may be requested during the hiring process.
Not Specified
A
Credentialing Specialist {166154}
Salary not disclosed
A-Line Staffing is now hiring a Credentialing Specialist in Summit, NJ .
The role would be working for a major healthcare company and has career growth potential.
This would be full time / 40+ hours per week.
If you are interested in this position, please contact Izzy P.
at A-Line! Credentialing Specialist – Compensation Pay range for this position is $28-$34 per hour Benefits are available to full-time employees after 90 days of employment A 401(k) with a company match is available for full-time employees with 1 year of service on our eligibility dates Highlights This position is a contract assignment with potential to hire permanently based on attendance, performance, and business needs Required availability for this position is 8:00 AM – 4:00 PM (Monday–Friday) Credentialing Specialist – Responsibilities Enforce regulatory compliance and quality assurance standards Prepare and maintain detailed credentialing reports and documentation Ensure all information meets federal, state, and legal guidelines Process applications for new providers and reappointments (125–200 quarterly) Collect, verify, and process licensing, accreditation, and background information Maintain accurate provider records in the Echo database Prepare materials for Credentials Committee, MEC, and Board of Trustees meetings Track license and certification expirations and ensure timely renewals Support privileging, payer enrollment, and compliance monitoring Maintain confidentiality of sensitive provider information Assist with scheduling, coordinating, and occasionally attending medical staff meetings Other duties as assigned Requirements Experience with hospital provider credentialing High School Diploma or GED Knowledge of the credentialing process is required Strong data research and analytical skills Excellent verbal and written communication skills Ability to work independently and manage multiple priorities Strong computer proficiency Attendance is mandatory for the first 90 days Preferred Qualifications Experience with Echo credentialing database Prior healthcare administrative experience If you think this position is a good fit for you, please reach out to me — feel free to call, email, or apply to this posting! -
The role would be working for a major healthcare company and has career growth potential.
This would be full time / 40+ hours per week.
If you are interested in this position, please contact Izzy P.
at A-Line! Credentialing Specialist – Compensation Pay range for this position is $28-$34 per hour Benefits are available to full-time employees after 90 days of employment A 401(k) with a company match is available for full-time employees with 1 year of service on our eligibility dates Highlights This position is a contract assignment with potential to hire permanently based on attendance, performance, and business needs Required availability for this position is 8:00 AM – 4:00 PM (Monday–Friday) Credentialing Specialist – Responsibilities Enforce regulatory compliance and quality assurance standards Prepare and maintain detailed credentialing reports and documentation Ensure all information meets federal, state, and legal guidelines Process applications for new providers and reappointments (125–200 quarterly) Collect, verify, and process licensing, accreditation, and background information Maintain accurate provider records in the Echo database Prepare materials for Credentials Committee, MEC, and Board of Trustees meetings Track license and certification expirations and ensure timely renewals Support privileging, payer enrollment, and compliance monitoring Maintain confidentiality of sensitive provider information Assist with scheduling, coordinating, and occasionally attending medical staff meetings Other duties as assigned Requirements Experience with hospital provider credentialing High School Diploma or GED Knowledge of the credentialing process is required Strong data research and analytical skills Excellent verbal and written communication skills Ability to work independently and manage multiple priorities Strong computer proficiency Attendance is mandatory for the first 90 days Preferred Qualifications Experience with Echo credentialing database Prior healthcare administrative experience If you think this position is a good fit for you, please reach out to me — feel free to call, email, or apply to this posting! -
Not Specified
D
Manager, Medical Affairs Quality, RD PV QA
🏢 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 Manager, Medical Affairs Quality will provide operational leadership and direction for assigned programs and, in close collaboration with the Sr.
Director, Medical Affairs QA, ensure implementation of the quality strategy and/or quality plan to promote a quality culture within Medical Affairs.
The Manager, Medical Affairs Quality supports quality oversight of strategic initiatives in partnership with Medical Affairs stakeholders to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials, real world evidence and managed access programs to the highest quality standards.
The role participates in the review of quality and compliance topics, including key quality indicators at Quality Governance Meetings, and works closely with DS QA teams (DSJ, DSI, DSE, DSBR) to proactively identify potential risks and opportunities for continuous improvement.
The Manager, Medical Affairs Quality, promotes end-to-end quality execution across programs, ensuring GCP, GVP, Data Protection, and other local requirements are considered in planning and conduct.
Acting as QA point person for assigned programs, the Manager collaborates with GxP Quality representatives (Development QA, Audits & Compliance, Quality Management System (QMS) QA including Vendor Quality, Pharmacovigilance QA and provides guidance during the development and execution of Corrective and Preventive Actions (CAPAs), including tracking timely closure, effectiveness checks, and escalation of critical issues.
The Manager facilitates regulatory inspection preparation, management, and follow-up in collaboration with business functions, supports local inspections with adequate systems and process support, and partners with QMS QA to ensure aligned implementation of applicable Quality Standards.
Additionally, the Manager identifies opportunities for continuous improvement in quality and compliance through lessons learned from audits, inspections, incidents, regulatory intelligence, and effectiveness checks, and provides interpretation of regulations and company process standards, guidelines, policies, and procedures for assigned programs or improvement projects.
The Manager champions and helps implement study/program-specific quality plans to ensure proactive management of quality and fosters strong relationships with stakeholders to drive a culture of compliance and operational excellence.
Job Description Responsibilities Leadership and Project Management: Promote end to end, comprehensive quality execution across assigned programs, ensuring GCP, GPV, Data Protection, and local requirements are integrated into the planning and conduct of Interventional, Non-interventional, Compassionate Use Managed Access Programs, and Investigator-Initiated Studies.
Provide operational quality oversight for Medical Affairs activities, including timely escalation of incidents/issues, monitoring deviations/incidents, supporting investigations, and coordinating with third-party vendors.
Serve as a key liaison to support audits and inspections as applicable Cross-functional and Global Team Participation: Participate in the review of quality and compliance topics, including KQI, at Quality Governance Meetings, in close alignment with DS QA teams (DSJ, DSI, DSE, DSBR) to proactively identify potential risks and opportunities for continuous improvement Provide quality oversight and uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials and managed access programs to the highest quality standards in close collaboration with Medical Affairs Stakeholders Collaborate with GxP Quality representatives and act as QA point person for all Medical Affairs programs.
Quality Management and Continuous Improvement: Provide guidance during the development and execution of CAPAs, including tracking of timely closure, effectiveness checks, and escalation of critical issues.
Partner with QMS QA to ensure aligned implementation of applicable Quality Standards in Medical Affairs and identify appropriate continuous improvement initiatives.
Provide interpretation of regulations and company process standards, guidelines, policies, and procedures for assigned programs or improvement projects.
Champion and help implement study/program-specific quality plans to ensure proactive management of quality Customer Focused/ stakeholder engagement: Work in close collaboration with Medical Affairs stakeholders to uphold ethical conduct and enhance compliance and quality standards across programs; share lessons learned and contribute to a quality mindset within Medical Affairs.
:
** Collaborates with QA line functions and Medical Affairs stakeholders to improve compliance and quality standards.
Acts as a QA point person for assigned programs .
Regulatory Inspections: Facilitate regulatory inspection preparation, management, and follow-up in collaboration with business functions; support local inspections with adequate systems and process support.
Contribute to lessons-learned information flow based on audits, inspections, incidents, regulatory intelligence, and effectiveness checks on process implementations and metrics.
Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines required Master's Degree Master's degree or other advanced degree preferred Experience Qualifications 4 or More Years Minimum of 5 years of experience in the pharmaceutical industry, preferably in clinical development or Medical Affairs, with exposure to regulated GCP environments required Profound knowledge of global drug development processes and regulations, including ICH-GCP, FDA/EU requirements, pharmacovigilance, and current industry practices preferred Ability to interpret and apply complex regulations, standards, and policies to operational activities preferred Experience supporting regulatory inspections and audits Demonstrated initiative in identifying and implementing process improvements Demonstrated experience supporting high-impact projects in a matrixed, global environment Strong interpersonal skills with the ability to build collaborative relationships across functions and geographies Excellent project management skills, including the ability to manage multiple priorities and deliver results in a dynamic business environment Effective verbal and written communication skills, with proficiency in presenting complex information to diverse audiences Strong analytical, problem-solving, and decision-making abilities Skilled at conflict resolution and negotiation, with a focus on achieving alignment and consensus Ability to work independently and as part of cross-functional teams, influencing and driving initiatives within assigned scope Flexibility and adaptability to changing business needs and priorities Organizational awareness, including understanding of interdepartmental relationships and business priorities 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$116.400,00
- USD$174.600,00 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, Medical Affairs Quality will provide operational leadership and direction for assigned programs and, in close collaboration with the Sr.
Director, Medical Affairs QA, ensure implementation of the quality strategy and/or quality plan to promote a quality culture within Medical Affairs.
The Manager, Medical Affairs Quality supports quality oversight of strategic initiatives in partnership with Medical Affairs stakeholders to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials, real world evidence and managed access programs to the highest quality standards.
The role participates in the review of quality and compliance topics, including key quality indicators at Quality Governance Meetings, and works closely with DS QA teams (DSJ, DSI, DSE, DSBR) to proactively identify potential risks and opportunities for continuous improvement.
The Manager, Medical Affairs Quality, promotes end-to-end quality execution across programs, ensuring GCP, GVP, Data Protection, and other local requirements are considered in planning and conduct.
Acting as QA point person for assigned programs, the Manager collaborates with GxP Quality representatives (Development QA, Audits & Compliance, Quality Management System (QMS) QA including Vendor Quality, Pharmacovigilance QA and provides guidance during the development and execution of Corrective and Preventive Actions (CAPAs), including tracking timely closure, effectiveness checks, and escalation of critical issues.
The Manager facilitates regulatory inspection preparation, management, and follow-up in collaboration with business functions, supports local inspections with adequate systems and process support, and partners with QMS QA to ensure aligned implementation of applicable Quality Standards.
Additionally, the Manager identifies opportunities for continuous improvement in quality and compliance through lessons learned from audits, inspections, incidents, regulatory intelligence, and effectiveness checks, and provides interpretation of regulations and company process standards, guidelines, policies, and procedures for assigned programs or improvement projects.
The Manager champions and helps implement study/program-specific quality plans to ensure proactive management of quality and fosters strong relationships with stakeholders to drive a culture of compliance and operational excellence.
Job Description Responsibilities Leadership and Project Management: Promote end to end, comprehensive quality execution across assigned programs, ensuring GCP, GPV, Data Protection, and local requirements are integrated into the planning and conduct of Interventional, Non-interventional, Compassionate Use Managed Access Programs, and Investigator-Initiated Studies.
Provide operational quality oversight for Medical Affairs activities, including timely escalation of incidents/issues, monitoring deviations/incidents, supporting investigations, and coordinating with third-party vendors.
Serve as a key liaison to support audits and inspections as applicable Cross-functional and Global Team Participation: Participate in the review of quality and compliance topics, including KQI, at Quality Governance Meetings, in close alignment with DS QA teams (DSJ, DSI, DSE, DSBR) to proactively identify potential risks and opportunities for continuous improvement Provide quality oversight and uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials and managed access programs to the highest quality standards in close collaboration with Medical Affairs Stakeholders Collaborate with GxP Quality representatives and act as QA point person for all Medical Affairs programs.
Quality Management and Continuous Improvement: Provide guidance during the development and execution of CAPAs, including tracking of timely closure, effectiveness checks, and escalation of critical issues.
Partner with QMS QA to ensure aligned implementation of applicable Quality Standards in Medical Affairs and identify appropriate continuous improvement initiatives.
Provide interpretation of regulations and company process standards, guidelines, policies, and procedures for assigned programs or improvement projects.
Champion and help implement study/program-specific quality plans to ensure proactive management of quality Customer Focused/ stakeholder engagement: Work in close collaboration with Medical Affairs stakeholders to uphold ethical conduct and enhance compliance and quality standards across programs; share lessons learned and contribute to a quality mindset within Medical Affairs.
:
** Collaborates with QA line functions and Medical Affairs stakeholders to improve compliance and quality standards.
Acts as a QA point person for assigned programs .
Regulatory Inspections: Facilitate regulatory inspection preparation, management, and follow-up in collaboration with business functions; support local inspections with adequate systems and process support.
Contribute to lessons-learned information flow based on audits, inspections, incidents, regulatory intelligence, and effectiveness checks on process implementations and metrics.
Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines required Master's Degree Master's degree or other advanced degree preferred Experience Qualifications 4 or More Years Minimum of 5 years of experience in the pharmaceutical industry, preferably in clinical development or Medical Affairs, with exposure to regulated GCP environments required Profound knowledge of global drug development processes and regulations, including ICH-GCP, FDA/EU requirements, pharmacovigilance, and current industry practices preferred Ability to interpret and apply complex regulations, standards, and policies to operational activities preferred Experience supporting regulatory inspections and audits Demonstrated initiative in identifying and implementing process improvements Demonstrated experience supporting high-impact projects in a matrixed, global environment Strong interpersonal skills with the ability to build collaborative relationships across functions and geographies Excellent project management skills, including the ability to manage multiple priorities and deliver results in a dynamic business environment Effective verbal and written communication skills, with proficiency in presenting complex information to diverse audiences Strong analytical, problem-solving, and decision-making abilities Skilled at conflict resolution and negotiation, with a focus on achieving alignment and consensus Ability to work independently and as part of cross-functional teams, influencing and driving initiatives within assigned scope Flexibility and adaptability to changing business needs and priorities Organizational awareness, including understanding of interdepartmental relationships and business priorities 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$116.400,00
- USD$174.600,00 Download Our Benefits Summary PDF
Not Specified
J
Quality Engineer
🏢 Jobot
Salary not disclosed
Growing company/ Great Benefits/ $$$ This Jobot Job is hosted by: Billy Mewton Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $110,000
- $125,000 per year A bit about us: Jobot is partnering with a leading manufacturing company to find a highly skilled QA/QC Engineer to join their team.
This is an exciting opportunity for an engineering professional with a strong background in quality systems, process audits, and compliance within a manufacturing environment.
The ideal candidate will have hands-on experience ensuring products and processes meet both internal standards and customer specifications.
Why join us? Benefits 401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Life insurance Job Details Job Details: We are seeking a dynamic and detail-oriented QA/QC Engineer to join our team.
This role is a permanent position in our manufacturing industry where you will be responsible for the implementation and management of quality control systems designed to ensure continuous production of advanced composite materials and applications consistent with established standards, customer specifications and production goals.
The successful candidate will have a hands-on approach and will be committed to the expansion and success of the business by implementing strategies that increase productivity and enable sales targets achievement.
Responsibilities: 1.
Develop and initiate standards and methods for inspection, testing, and evaluation.
2.
Devise sampling procedures and design and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
3.
Establish program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.
4.
Develop and implement methods and procedures for disposition of discrepant material and devise methods to assess cost and responsibility.
5.
Direct workers engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability.
6.
Compile and write training material and conduct training sessions on quality control activities.
7.
Support Quality Assurance activities and participate in the company's continuous improvement initiative.
8.
Apply total quality management tools and approaches to analytical and reporting processes within each department.
9.
Create, document and implement inspection criteria and procedures.
10.
Interpret quality control philosophy to key personnel within the company.
Qualifications: 1.
Associate's or Bachelor's degree in Engineering or a related field.
2.
Certified Welding Inspectors is preferred but not required.
3.
Minimum of 5 years of work experience in Quality Assurance/Quality Control in the manufacturing industry.
4.
Proven experience in the implementation of quality assurance programs.
5.
Demonstrated knowledge of testing best practices, version control practices and defect management practice.
6.
Excellent analytical and problem-solving skills.
7.
Strong computer skills including Microsoft Office Suite and databases.
8.
Knowledge of tools, concepts and methodologies of QA.
9.
Excellent oral and written communication skills.
10.
Ability to work in a team and independently.
11.
Strong attention to detail and results-driven approach.
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: $110,000
- $125,000 per year A bit about us: Jobot is partnering with a leading manufacturing company to find a highly skilled QA/QC Engineer to join their team.
This is an exciting opportunity for an engineering professional with a strong background in quality systems, process audits, and compliance within a manufacturing environment.
The ideal candidate will have hands-on experience ensuring products and processes meet both internal standards and customer specifications.
Why join us? Benefits 401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Life insurance Job Details Job Details: We are seeking a dynamic and detail-oriented QA/QC Engineer to join our team.
This role is a permanent position in our manufacturing industry where you will be responsible for the implementation and management of quality control systems designed to ensure continuous production of advanced composite materials and applications consistent with established standards, customer specifications and production goals.
The successful candidate will have a hands-on approach and will be committed to the expansion and success of the business by implementing strategies that increase productivity and enable sales targets achievement.
Responsibilities: 1.
Develop and initiate standards and methods for inspection, testing, and evaluation.
2.
Devise sampling procedures and design and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
3.
Establish program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.
4.
Develop and implement methods and procedures for disposition of discrepant material and devise methods to assess cost and responsibility.
5.
Direct workers engaged in measuring and testing product and tabulating data concerning materials, product, or process quality and reliability.
6.
Compile and write training material and conduct training sessions on quality control activities.
7.
Support Quality Assurance activities and participate in the company's continuous improvement initiative.
8.
Apply total quality management tools and approaches to analytical and reporting processes within each department.
9.
Create, document and implement inspection criteria and procedures.
10.
Interpret quality control philosophy to key personnel within the company.
Qualifications: 1.
Associate's or Bachelor's degree in Engineering or a related field.
2.
Certified Welding Inspectors is preferred but not required.
3.
Minimum of 5 years of work experience in Quality Assurance/Quality Control in the manufacturing industry.
4.
Proven experience in the implementation of quality assurance programs.
5.
Demonstrated knowledge of testing best practices, version control practices and defect management practice.
6.
Excellent analytical and problem-solving skills.
7.
Strong computer skills including Microsoft Office Suite and databases.
8.
Knowledge of tools, concepts and methodologies of QA.
9.
Excellent oral and written communication skills.
10.
Ability to work in a team and independently.
11.
Strong attention to detail and results-driven approach.
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
J
Project Manager - Power or Energy Industry required
🏢 Jobot
Salary not disclosed
Growing company/ Excellent Benefits/ $$$ This Jobot Job is hosted by: Billy Mewton Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $140,000
- $160,000 per year A bit about us: Our client, a leading company in the power construction industry, is seeking an experienced Project Manager to oversee large-scale electrical infrastructure and power distribution projects.
This position offers the opportunity to manage high-impact utility and industrial power projects from conception through completion, ensuring safety, quality, and on-time delivery.
Why join us? Benefits 401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Life insurance Job Details Job Details: As a Permanent Project Manager in the Power or Energy Industry, you will play a pivotal role in our Manufacturing sector.
We are seeking a seasoned professional who will manage and oversee multiple projects related to power and energy.
You will be the driving force behind project planning, execution, and delivery, ensuring all projects are completed on time, within budget, and to the highest quality standards.
This role requires a dynamic, high-energy individual with a proven track record in the power or energy industry.
Responsibilities: 1.
Plan, manage, and execute multiple power or energy projects, ensuring they are delivered on time, within scope, and within budget.
2.
Develop and maintain comprehensive project plans, outlining tasks, resources, timelines, costs, and project dependencies.
3.
Manage relationships with all stakeholders, including clients, vendors, and internal teams.
4.
Negotiate contracts with vendors and suppliers, ensuring the best possible terms for the company.
5.
Monitor project progress continuously, making necessary adjustments to deadlines and resources to ensure project success.
6.
Prepare and present project progress reports to stakeholders, keeping them informed about project status and issues that may impact project delivery.
7.
Identify and manage potential risks and issues, implementing mitigation strategies as needed.
8.
Ensure compliance with all relevant industry regulations and company policies.
9.
Foster a positive work environment that encourages teamwork, innovation, and excellence.
Qualifications: 1.
A minimum of 5 years of experience in Project Management in the Power or Energy industry.
2.
Bachelor's degree in Engineering or a related field.
A Master’s degree or Project Management Professional (PMP) certification will be an added advantage.
3.
Demonstrated experience in project delivery, contract negotiation, budget management, and scheduling.
4.
Proven track record of managing vendors and suppliers.
5.
Excellent leadership and team management skills, with the ability to inspire and motivate teams.
6.
Strong problem-solving skills with the ability to make sound decisions under pressure.
7.
Exceptional communication and presentation skills, with the ability to effectively communicate complex concepts to diverse audiences.
8.
Proficient in project management software and tools.
9.
Knowledge of the manufacturing industry and relevant regulations is a plus.
This is an exciting opportunity to contribute to our growth and success while advancing your career in a dynamic and fast-paced industry.
If you are passionate about project management and have a proven track record in the power or energy industry, we would love to hear from you.
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: $140,000
- $160,000 per year A bit about us: Our client, a leading company in the power construction industry, is seeking an experienced Project Manager to oversee large-scale electrical infrastructure and power distribution projects.
This position offers the opportunity to manage high-impact utility and industrial power projects from conception through completion, ensuring safety, quality, and on-time delivery.
Why join us? Benefits 401(k) 401(k) matching Dental insurance Flexible schedule Flexible spending account Health insurance Life insurance Job Details Job Details: As a Permanent Project Manager in the Power or Energy Industry, you will play a pivotal role in our Manufacturing sector.
We are seeking a seasoned professional who will manage and oversee multiple projects related to power and energy.
You will be the driving force behind project planning, execution, and delivery, ensuring all projects are completed on time, within budget, and to the highest quality standards.
This role requires a dynamic, high-energy individual with a proven track record in the power or energy industry.
Responsibilities: 1.
Plan, manage, and execute multiple power or energy projects, ensuring they are delivered on time, within scope, and within budget.
2.
Develop and maintain comprehensive project plans, outlining tasks, resources, timelines, costs, and project dependencies.
3.
Manage relationships with all stakeholders, including clients, vendors, and internal teams.
4.
Negotiate contracts with vendors and suppliers, ensuring the best possible terms for the company.
5.
Monitor project progress continuously, making necessary adjustments to deadlines and resources to ensure project success.
6.
Prepare and present project progress reports to stakeholders, keeping them informed about project status and issues that may impact project delivery.
7.
Identify and manage potential risks and issues, implementing mitigation strategies as needed.
8.
Ensure compliance with all relevant industry regulations and company policies.
9.
Foster a positive work environment that encourages teamwork, innovation, and excellence.
Qualifications: 1.
A minimum of 5 years of experience in Project Management in the Power or Energy industry.
2.
Bachelor's degree in Engineering or a related field.
A Master’s degree or Project Management Professional (PMP) certification will be an added advantage.
3.
Demonstrated experience in project delivery, contract negotiation, budget management, and scheduling.
4.
Proven track record of managing vendors and suppliers.
5.
Excellent leadership and team management skills, with the ability to inspire and motivate teams.
6.
Strong problem-solving skills with the ability to make sound decisions under pressure.
7.
Exceptional communication and presentation skills, with the ability to effectively communicate complex concepts to diverse audiences.
8.
Proficient in project management software and tools.
9.
Knowledge of the manufacturing industry and relevant regulations is a plus.
This is an exciting opportunity to contribute to our growth and success while advancing your career in a dynamic and fast-paced industry.
If you are passionate about project management and have a proven track record in the power or energy industry, we would love to hear from you.
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 PV Quality, Americas
🏢 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 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 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.
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Medical Receptionist
🏢 Jobot
Salary not disclosed
Contract to Perm Position with a Orthopedic Group in Hunterdon County.
M-F with OT on Saturdays Available.
IMMEDIATE HIRE This Jobot Consulting Job is hosted by: Adam Cejnowski Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $18
- $20 per hour A bit about us: Orthopedic group in Central NJ is looking to hire medical office professionals in multiple locations throughout central NJ .
If you are looking for a career move without the long daily commutes here in NJ please APPLY Why join us? Excellent career potential flex start times benefits after contract Contract to perm Saturday overtime available Friendly and supportive team If you would like more details about this position please email a confidential resume to or call 949.996.8921 Job Details M-F 8-5 or 9-530 Contract to Perm Answering phones, customer service, patient check in's, schedule appointments Saturdays available for OT If you would like more details about this position please email a confidential resume to or call 949.996.8921 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
M-F with OT on Saturdays Available.
IMMEDIATE HIRE This Jobot Consulting Job is hosted by: Adam Cejnowski Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $18
- $20 per hour A bit about us: Orthopedic group in Central NJ is looking to hire medical office professionals in multiple locations throughout central NJ .
If you are looking for a career move without the long daily commutes here in NJ please APPLY Why join us? Excellent career potential flex start times benefits after contract Contract to perm Saturday overtime available Friendly and supportive team If you would like more details about this position please email a confidential resume to or call 949.996.8921 Job Details M-F 8-5 or 9-530 Contract to Perm Answering phones, customer service, patient check in's, schedule appointments Saturdays available for OT If you would like more details about this position please email a confidential resume to or call 949.996.8921 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
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