Engineering Structures Journal Elsevier Jobs in Raritan
41 positions found — Page 4
D
Manager, GMA Oncology Publications
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 Manager, Global Medical Affairs Oncology Publications works with GMA Oncology Publications Lead, to support development of publication plans, drive the execution of publication projects, and support other GMA Oncology activities as needed for their assigned product, in collaboration with the GMA Team Lead and other GMA functions.
Job Description Responsibilities Collaborate with Global and Regional Medical Affairs and various cross functional teams or alliance partners as needed to develop publication plans of assigned GMA Oncology product Support GMA Oncology Publications Lead Supports execution and delivery of publication projects to ensure high quality and timely delivery of scientific publications Manage publication activities in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author approvals Ensure documentation of compliance with authorship and publication guidelines as stipulated by the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP) Work with GMA Oncology Publications Lead and publication vendors to ensure deliverables are of high quality, delivered in a timely manner, and in budget.
Liaise with internal and external stakeholders, including authors, researchers, investigators, GMA Therapy Area leads, R&D clinical leads, biostatistics and Joint Publications Team members on publication activities Participate and support joint publications team discussions, including monthly, quarterly and yearly publication update meetings as needed oManage timelines of publication output oLiaise with internal & external authors, academic research organizations, and study investigators oSupport tracking of vendor budget and activities oOversee the quality and timeline of vendor work oCoordinate study clinical or medical lead and biostats input to ensure availability of necessary data oCoordinate author review/approval & internal review approval oAbstract/manuscript submission with vendor support oSupport preparation of responses to journal reviewer comments/requests oSupport as needed publication tracking and announcement, in coordination with Medical Information & Education Attend with related meetings related to publications with or on behalf of GMA Oncology Publications Lead as needed Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree in Health Sciences may be considered based on years of experience/qualifications.
required and PharmD in Health Sciences preferred or PhD in Health Sciences preferred Experience Qualifications 1 or More Years of pharmaceutical industry, clinical, and/or academic experience.
required Travel Requirements Ability to travel up to 20% of the time.
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$124.960,00
- USD$187.440,00 Download Our Benefits Summary PDF
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary Manager, Global Medical Affairs Oncology Publications works with GMA Oncology Publications Lead, to support development of publication plans, drive the execution of publication projects, and support other GMA Oncology activities as needed for their assigned product, in collaboration with the GMA Team Lead and other GMA functions.
Job Description Responsibilities Collaborate with Global and Regional Medical Affairs and various cross functional teams or alliance partners as needed to develop publication plans of assigned GMA Oncology product Support GMA Oncology Publications Lead Supports execution and delivery of publication projects to ensure high quality and timely delivery of scientific publications Manage publication activities in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author approvals Ensure documentation of compliance with authorship and publication guidelines as stipulated by the International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP) Work with GMA Oncology Publications Lead and publication vendors to ensure deliverables are of high quality, delivered in a timely manner, and in budget.
Liaise with internal and external stakeholders, including authors, researchers, investigators, GMA Therapy Area leads, R&D clinical leads, biostatistics and Joint Publications Team members on publication activities Participate and support joint publications team discussions, including monthly, quarterly and yearly publication update meetings as needed oManage timelines of publication output oLiaise with internal & external authors, academic research organizations, and study investigators oSupport tracking of vendor budget and activities oOversee the quality and timeline of vendor work oCoordinate study clinical or medical lead and biostats input to ensure availability of necessary data oCoordinate author review/approval & internal review approval oAbstract/manuscript submission with vendor support oSupport preparation of responses to journal reviewer comments/requests oSupport as needed publication tracking and announcement, in coordination with Medical Information & Education Attend with related meetings related to publications with or on behalf of GMA Oncology Publications Lead as needed Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree in Health Sciences may be considered based on years of experience/qualifications.
required and PharmD in Health Sciences preferred or PhD in Health Sciences preferred Experience Qualifications 1 or More Years of pharmaceutical industry, clinical, and/or academic experience.
required Travel Requirements Ability to travel up to 20% of the time.
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$124.960,00
- USD$187.440,00 Download Our Benefits Summary PDF
Not Specified
D
Associate Director, Regulatory Affairs CMC and Digital Transformation
🏢 Daiichi Sankyo, Inc.
Salary not disclosed
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines.
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug projects consistent with the company goals.
Participate on G-RACMC teams and support or lead on Component teams and/or serve as G-RACMC lead or regional submission lead.
Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams leading to sound scientific development programs and successful registration for new compounds.
Performs collaborative authoring with other RACMC regional team members and subject matter experts for Health Authority (HA) submission, HA meetings, and responses to HA queries.
Support company goals to building filing strategies that lead to efficient submission timeline and approvals in assigned region.
Digital Transformation Responsibilities: The Associate Director, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and next-generation digital capabilities.
This role is critical to enabling the future of regulatory submissions, modernizing end-to-end CMC data management, and positioning the company for global competitiveness in an increasingly data-driven biopharmaceutical landscape.
Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Responsibilities Organize and manage the preparation (content and format) of all types of submissions to Health Authorities.
Coordinates activities required for timely and accurate reporting of information to existing submissions.
Supervise the identification and compilation of required documentation for submission.
Prioritizes workload.
Evaluate content and adequacy of submissions and identify deficiencies against regulatory guidance’s or internal data bases.
Facilitate and support liaison activities with functional groups within Daiichi Sankyo, Inc.
related to assigned products/project areas such as the clinical supplies organization, Reg Operations, Medical Affairs and labelling.
Participates in meetings with Health Authorities.
Prepares internal functional teams for these interactions to build strong relationships with FDA and secure successful meeting outcomes.
Coordinates preparation, authors, and finalizes meeting materials to include meeting requests, briefing books and meeting minutes.
Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical seminars, global forums or trip reports.
Participates on external industry consortiums (DS Consortium and Biophorum) to understand industry standards and contribute to policies and or standards.
Identifies areas for process /procedure improvements and works on improvement implementation.
Provides training on evolving regulations.
This could involve Global RACMC teams or cross-functional initiatives within the company.
Lead the transition to structured CMC data, including data standards, metadata models, and systems that support machine-readable regulatory submissions.
Drive digital modernization by implementing tools for structured content authoring, automated data transfer, and data-driven dossier creation.
Enable automation, AI, and analytics to reduce manual data handling, improve data integrity, and enhance decision-making across CMC functions.
Partner cross-functionally with CMC, Quality, Manufacturing, Technical Operations, Regulatory, and IT to ensure alignment and readiness for structured data capabilities.
Manage organizational change, including capability building, training, and communication to support adoption of new digital processes.
Monitor global regulatory and industry trends and lead internal initiatives that position the company for future structured submission expectations and digital regulatory innovations.
Qualifications Education Qualifications Bachelor's Degree Life Science Degree required Master's Degree preferred PharmD preferred Experience Qualifications 7 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields required Experience in Digital Transformation within Regulatory CMC required Experience in international Regulatory Affairs– CMC preferred Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Travel Requirements Ability to travel up to 10% of the time.
Daiichi Sankyo, Inc.
is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range: USD$159.440,00
- USD$239.160,00 Download Our Benefits Summary PDF
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug projects consistent with the company goals.
Participate on G-RACMC teams and support or lead on Component teams and/or serve as G-RACMC lead or regional submission lead.
Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams leading to sound scientific development programs and successful registration for new compounds.
Performs collaborative authoring with other RACMC regional team members and subject matter experts for Health Authority (HA) submission, HA meetings, and responses to HA queries.
Support company goals to building filing strategies that lead to efficient submission timeline and approvals in assigned region.
Digital Transformation Responsibilities: The Associate Director, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and next-generation digital capabilities.
This role is critical to enabling the future of regulatory submissions, modernizing end-to-end CMC data management, and positioning the company for global competitiveness in an increasingly data-driven biopharmaceutical landscape.
Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Responsibilities Organize and manage the preparation (content and format) of all types of submissions to Health Authorities.
Coordinates activities required for timely and accurate reporting of information to existing submissions.
Supervise the identification and compilation of required documentation for submission.
Prioritizes workload.
Evaluate content and adequacy of submissions and identify deficiencies against regulatory guidance’s or internal data bases.
Facilitate and support liaison activities with functional groups within Daiichi Sankyo, Inc.
related to assigned products/project areas such as the clinical supplies organization, Reg Operations, Medical Affairs and labelling.
Participates in meetings with Health Authorities.
Prepares internal functional teams for these interactions to build strong relationships with FDA and secure successful meeting outcomes.
Coordinates preparation, authors, and finalizes meeting materials to include meeting requests, briefing books and meeting minutes.
Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical seminars, global forums or trip reports.
Participates on external industry consortiums (DS Consortium and Biophorum) to understand industry standards and contribute to policies and or standards.
Identifies areas for process /procedure improvements and works on improvement implementation.
Provides training on evolving regulations.
This could involve Global RACMC teams or cross-functional initiatives within the company.
Lead the transition to structured CMC data, including data standards, metadata models, and systems that support machine-readable regulatory submissions.
Drive digital modernization by implementing tools for structured content authoring, automated data transfer, and data-driven dossier creation.
Enable automation, AI, and analytics to reduce manual data handling, improve data integrity, and enhance decision-making across CMC functions.
Partner cross-functionally with CMC, Quality, Manufacturing, Technical Operations, Regulatory, and IT to ensure alignment and readiness for structured data capabilities.
Manage organizational change, including capability building, training, and communication to support adoption of new digital processes.
Monitor global regulatory and industry trends and lead internal initiatives that position the company for future structured submission expectations and digital regulatory innovations.
Qualifications Education Qualifications Bachelor's Degree Life Science Degree required Master's Degree preferred PharmD preferred Experience Qualifications 7 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields required Experience in Digital Transformation within Regulatory CMC required Experience in international Regulatory Affairs– CMC preferred Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Travel Requirements Ability to travel up to 10% of the time.
Daiichi Sankyo, Inc.
is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range: USD$159.440,00
- USD$239.160,00 Download Our Benefits Summary PDF
Not Specified
S
Mental Health Therapist
$86 - $106 / hour
SonderMind is a leading mental health care platform revolutionizing therapy services by empowering licensed mental health therapists to deliver exceptional care with cutting-edge, AI-powered tools. We are seeking compassionate and highly skilled clinicians to join our expanding network, offering the flexibility to manage your own practice, bring your existing clients, and benefit from steady referrals.
At SonderMind, we believe there can’t be mental healthcare without mentally-strong clinicians. Our platform is designed to outsmart burnout and streamline your workflow, allowing you to focus on what matters most—your clients. We are committed to fostering relationship-driven care, providing ethically grounded, human-first tools that enhance outcomes and reduce administrative burdens.
Benefits of Joining SonderMind:
- Flexibility: Enjoy the freedom to set your own working hours and maintain a healthy work-life balance. Sessions can be conducted via telehealth or in-person.
- Free and stress-free credentialing with major insurers: We have streamlined the credentialing process and handle all the hard stuff for you so that you can expand your practice by accepting insurance from major payors in your state in weeks, not months.
- Guaranteed Pay: We handle all the billing for you and guarantee pay bi-weekly for completed sessions-including no-shows.
- Referrals and Practice Support: Seamlessly onboard your existing clients while receiving new referrals. Benefit from thoughtful client matching to personalize your caseload, with support from a dedicated account manager to help you grow your practice across various specialties.
- Absolutely no fees or membership charges: We don’t charge you to deliver care, and all of the features, access, tools, and resources you get come free of charge.
- Innovative AI-Powered Tools: Outsmart burnout and focus on what matters most—your clients. Our secure, clinically-developed AI tools eliminate administrative tasks and keep clients engaged between sessions. This includes:
- AI Notes: Auto-generates editable, insurance-compliant clinical notes, saving you time and reducing documentation burden.
- Session Takeaways: Extend your care between sessions by reviewing and sending client-friendly summaries of key insights.
- Session Prep: Help clients clarify goals and focus areas before each session, ensuring you hit the ground running.
- Goal Setting: Collaborate with clients to set and track goals, increasing engagement and accountability.
- Treatment Plan: Easily align with clients on diagnoses, goals, and care plans in a clear, clinically grounded format.
- Reflections: Clients can journal through AI-guided prompts between sessions, providing you with deeper context.
Requirements:
- Master's degree or higher in counseling, psychology, social work, or a related field.
- Must be fully licensed by the State Board to provide therapy independently and without supervision (e.g., LPC, LCSW, LMFT, LMHC, LCPC, LCSW-C, LISW, or LP).
Pay: $86-$106 per hour. Pay rates are based on the provider license type, session location, and session types.
*Please note that SonderMind does not provide office space; therapists are responsible for securing their own location for in-person sessions, but we can help connect you with other SonderMind therapists looking to share space.
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
Director, US Omnichannel Marketing Analytics
🏢 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 Director, US Omnichannel Marketing Analytics Lead provides analytics leadership on behalf of the US Oncology Business Division to support the US Omnichannel strategy.
This role defines the omnichannel analytics vision and roadmap, oversees campaign measurement, customer engagement insights, consistent reporting, and ROI assessment across channels.
The Director partners with Marketing, IT, Commercial Analytics, and external vendors to translate business needs into actionable insights and ensure analytics are effectively leveraged to optimize marketing performance.
This role leads through cross-functional influence to ensure analytics are consistently applied to optimize marketing performance.
Responsibilities Strategy and Vision Own and drive the strategy and execution of omnichannel marketing analytics and reporting capabilities across US Omnichannel Collaborate closely with the Technology and Data teams to define and prioritize technology and data enablement requirements that support the analytics vision and business objectives Develop standardized reporting KPIs and metrics to track the effectiveness of omnichannel engagement Drive integration of omnichannel dynamics with broader analytics activities Analytics and Measurement Lead the consolidation of analytics and reporting needs for Omnichannel marketing.
Develop a robust, modular, and extensible reporting framework to minimize redundant work, streamline ad hoc requests, and ensure consistent data views for all stakeholders.
Design, develop, and implement measurement and optimization frameworks for all Paid, Owned, and Earned media channels (HCP and DTC) Drive the operationalization of actionable insights by integrating outputs from diverse analytics and reporting initiatives.
Ensure these insights are effectively communicated and leveraged to advance Omnichannel business outcomes and support data-driven decision-making.
Manage and communicate reporting / measurement results consistently through appropriate forums Manage strategic tagging of campaign content to align with ongoing reporting and measurement plans Define campaign analytics, A/B testing, and deep-dive analyses to assess omnichannel marketing effectiveness and ROI Oversee and guide real-time analytics using AI/ML (in-flight optimization), ensuring teams and partners deliver actionable insights aligned to omnichannel objectives.
Lead development and execution of patient-journey based alerts programs integrated with omnichannel initiatives Analytics Systems and Tools Inform the adoption of scalable analytics systems, partnering closely with IT / DX, Commercial Analytics, and Data teams to ensure solutions meet business needs Ensures analytics platforms and tools leverage advanced analytics techniques and meets the needs of the US Omnichannel objectives Collaborate with IT / DX and Data teams to ensure analytics infrastructure meets security, compliance, and performance standards.
Coordinate input from vendor partners and ensure deliverables are met Qualifications Education Qualifications Bachelor’s degree in Mathematics, Statistics, Computer Science, Engineering, Analytics, Business, or other technical degree required.
Master of Science or MBA Advanced degree in a quantitative subject (e.g., Statistics, Analytics, Econometrics, Mathematics) preferred Experience Qualifications 10+ years of overall experience in business data analytics, information management, business intelligence, and reporting required 5 years of experience within the pharmaceutical or healthcare industry, including experience working within the US pharmaceutical market, supporting centralized data and reporting strategies for specialty products strongly preferred Experience in other highly data-driven industries (e.g.
retail, CPG, financial services) may also be considered if demonstrating strong success in digital and analytical focused insights Travel Requirements Ability to travel up to 20% of the time.
Strategic planning meetings, task force meetings, and training initiatives 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$198.160,00
- USD$297.240,00 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 Director, US Omnichannel Marketing Analytics Lead provides analytics leadership on behalf of the US Oncology Business Division to support the US Omnichannel strategy.
This role defines the omnichannel analytics vision and roadmap, oversees campaign measurement, customer engagement insights, consistent reporting, and ROI assessment across channels.
The Director partners with Marketing, IT, Commercial Analytics, and external vendors to translate business needs into actionable insights and ensure analytics are effectively leveraged to optimize marketing performance.
This role leads through cross-functional influence to ensure analytics are consistently applied to optimize marketing performance.
Responsibilities Strategy and Vision Own and drive the strategy and execution of omnichannel marketing analytics and reporting capabilities across US Omnichannel Collaborate closely with the Technology and Data teams to define and prioritize technology and data enablement requirements that support the analytics vision and business objectives Develop standardized reporting KPIs and metrics to track the effectiveness of omnichannel engagement Drive integration of omnichannel dynamics with broader analytics activities Analytics and Measurement Lead the consolidation of analytics and reporting needs for Omnichannel marketing.
Develop a robust, modular, and extensible reporting framework to minimize redundant work, streamline ad hoc requests, and ensure consistent data views for all stakeholders.
Design, develop, and implement measurement and optimization frameworks for all Paid, Owned, and Earned media channels (HCP and DTC) Drive the operationalization of actionable insights by integrating outputs from diverse analytics and reporting initiatives.
Ensure these insights are effectively communicated and leveraged to advance Omnichannel business outcomes and support data-driven decision-making.
Manage and communicate reporting / measurement results consistently through appropriate forums Manage strategic tagging of campaign content to align with ongoing reporting and measurement plans Define campaign analytics, A/B testing, and deep-dive analyses to assess omnichannel marketing effectiveness and ROI Oversee and guide real-time analytics using AI/ML (in-flight optimization), ensuring teams and partners deliver actionable insights aligned to omnichannel objectives.
Lead development and execution of patient-journey based alerts programs integrated with omnichannel initiatives Analytics Systems and Tools Inform the adoption of scalable analytics systems, partnering closely with IT / DX, Commercial Analytics, and Data teams to ensure solutions meet business needs Ensures analytics platforms and tools leverage advanced analytics techniques and meets the needs of the US Omnichannel objectives Collaborate with IT / DX and Data teams to ensure analytics infrastructure meets security, compliance, and performance standards.
Coordinate input from vendor partners and ensure deliverables are met Qualifications Education Qualifications Bachelor’s degree in Mathematics, Statistics, Computer Science, Engineering, Analytics, Business, or other technical degree required.
Master of Science or MBA Advanced degree in a quantitative subject (e.g., Statistics, Analytics, Econometrics, Mathematics) preferred Experience Qualifications 10+ years of overall experience in business data analytics, information management, business intelligence, and reporting required 5 years of experience within the pharmaceutical or healthcare industry, including experience working within the US pharmaceutical market, supporting centralized data and reporting strategies for specialty products strongly preferred Experience in other highly data-driven industries (e.g.
retail, CPG, financial services) may also be considered if demonstrating strong success in digital and analytical focused insights Travel Requirements Ability to travel up to 20% of the time.
Strategic planning meetings, task force meetings, and training initiatives 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$198.160,00
- USD$297.240,00 Download Our Benefits Summary PDF
Not Specified
F
Side Hustle Specialist (Evenings & Weekends)
$300-$1,200 per month (part-time) - monthly
We’re seeking dependable individuals who want to build a side income alongside their full-time work. This role offers flexible tasks you can perform outside your regular job hours. You’ll be given structured guidance and tools to identify side hustles that complement your main job, without conflict or burnout.
Responsibilities:
Work through curated side-hustle ideas and evaluate which suit your skills and schedule
Test and implement methods to generate extra income (e.g. remote tasks, micro-projects)
Track your time and earnings; maintain simple reports
Adjust your workflow and focus on the side hustles that deliver the best return
Requirements:
Must have a full-time job already (or other main commitment)
Reliable internet access and a device (laptop, tablet or smartphone)
Basic organization skills and ability to work independently
Willingness to learn and experiment
Preferred Qualities:
Self-motivated
Good at managing time
Comfortable trying new things
Able to commit a few hours each week
Benefits:
Work on your own schedule (evenings/weekends)
Low risk; minimal overhead
Opportunity to scale income over time
Support and guidance provided
temporary
F
Part-Time Side Work - Earn on Top of Your Day Job
🏢 Finance Buzz
$300-$1,200 per month (depending on effort) - monthly
We’re looking for people interested in a part-time remote opportunity to supplement their main income. This position is ideal for professionals, freelancers, and anyone who wants to improve their financial situation with flexible, manageable work.
You’ll receive access to structured resources explaining simple, effective ways to earn extra income using your existing skills and free time.
Responsibilities:
Review step-by-step guides and apply them independently
Choose methods that fit your experience and lifestyle
Monitor and report your own results to measure progress
Maintain consistency and reliability
Requirements:
Reliable internet connection and basic computer literacy
Strong self-motivation and time management
Comfortable working independently
Willingness to learn new approaches
Benefits:
Remote and flexible schedule
No selling or cold calling
Practical ways to build a stable side income
Opportunity for long-term financial growth
temporary
J
Attorney
🏢 Jobot
Salary not disclosed
Attorney Needed
- Commission Only
- Growing Law Firm This Jobot Job is hosted by: Steven Zacharias Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $80,000
- $300,000 per year A bit about us: We are a growing law firm that's looking to hire a seasoned Attorney in New Jersey ASAP! If interested, please apply or email me your resume directly at
- /> Why join us? Compensation structure is based on one-third of what the attorney bills.
Annual earnings can range from approximately $80,000 to well over $250,000, depending on productivity.
Health, Dental, Vision 401k PTO Job Details Summary: The ideal candidate will possess a strong background in various areas of law, including Civil litigation, and family law.
This role requires excellent negotiation skills, legal drafting capabilities, and proficiency in legal research tools such as Lexis-Nexis or Westlaw.
The Attorney will be responsible for providing legal advice, representing clients in legal matters, and ensuring compliance with applicable laws and regulations.
Scope of Responsibilities: Provide comprehensive legal advice to clients on a variety of legal issues.
Represent clients in court proceedings, negotiations, and other legal matters.
Draft and review legal documents, including contracts, pleadings, and motions.
Conduct thorough research using Lexis-Nexis and Westlaw to support case strategies.
Negotiate settlements on behalf of clients while advocating for their best interests.
Stay updated on changes in laws and regulations that may impact clients.
Collaborate with other attorneys and legal staff to ensure effective case management.
Maintain accurate records of all legal proceedings and communications.
Qualifications: Juris Doctor (JD) degree from an accredited law school.
Admission to the bar in New Jersey in Good Standing.
Experience in Civil Litigation and Family Law is preferred but not required.
Demonstrated ability to write clearly and persuasively in various legal contexts.
Familiarity with negotiation techniques and strategies is essential.
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
- Commission Only
- Growing Law Firm This Jobot Job is hosted by: Steven Zacharias Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $80,000
- $300,000 per year A bit about us: We are a growing law firm that's looking to hire a seasoned Attorney in New Jersey ASAP! If interested, please apply or email me your resume directly at
- /> Why join us? Compensation structure is based on one-third of what the attorney bills.
Annual earnings can range from approximately $80,000 to well over $250,000, depending on productivity.
Health, Dental, Vision 401k PTO Job Details Summary: The ideal candidate will possess a strong background in various areas of law, including Civil litigation, and family law.
This role requires excellent negotiation skills, legal drafting capabilities, and proficiency in legal research tools such as Lexis-Nexis or Westlaw.
The Attorney will be responsible for providing legal advice, representing clients in legal matters, and ensuring compliance with applicable laws and regulations.
Scope of Responsibilities: Provide comprehensive legal advice to clients on a variety of legal issues.
Represent clients in court proceedings, negotiations, and other legal matters.
Draft and review legal documents, including contracts, pleadings, and motions.
Conduct thorough research using Lexis-Nexis and Westlaw to support case strategies.
Negotiate settlements on behalf of clients while advocating for their best interests.
Stay updated on changes in laws and regulations that may impact clients.
Collaborate with other attorneys and legal staff to ensure effective case management.
Maintain accurate records of all legal proceedings and communications.
Qualifications: Juris Doctor (JD) degree from an accredited law school.
Admission to the bar in New Jersey in Good Standing.
Experience in Civil Litigation and Family Law is preferred but not required.
Demonstrated ability to write clearly and persuasively in various legal contexts.
Familiarity with negotiation techniques and strategies is essential.
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
Manager, PV Quality Management
🏢 Daiichi Sankyo, Inc.
Salary not disclosed
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines.
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary This position supports the Associate Director, PV Quality & Compliance, PV Quality Management in the establishment, implementation, and oversight of the CSPV Quality, Compliance and Training function.
This position is responsible for managing activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance reports relative to safety reporting processes and regulatory authority submissions.
This role is the primary CSPV contact for Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections conducted by global Health Authorities/Regulatory Authorities (HAs/RAs) and PV audits conducted by DS Quality Assurance and License Partners/Affiliates, as applicable.
This position is responsible for facilitating audit and inspection-related activities within CSPV and supports the development of inspection readiness initiatives.
This position is responsibility for identifying training needs for CSPV staff and developing and overseeing training to ensure awareness of and compliance with organizational objectives and global laws and regulatory requirements.
With support from the Associate Director, PV Quality & Compliance, PV Quality Management, this position will take a lead role in the design, development, and coordination of training programs based on corporate, organizational and individual needs, collaborating with CSPV management and cross-functionally to ensure training needs are met.
This position is responsible for the design and development of a procedural document management program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
This position liaises with CSPV management and cross-functional teams as necessary throughout the corporation to drive a culture of regulatory compliance and ensure effective and efficient management of CSPV activities.
Job Description Responsibilities Quality and Compliance: Manages activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance metrics reports relative to the safety reporting and regulatory submission of individual case safety reports (ICSRs) and aggregate periodic safety reports.
Drives and manages an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis, root cause analysis and implementation of process improvement measures and effectiveness checks.
Leads audit/inspection readiness activities including but not limited to conducting routine/periodic quality assurance assessments to measure and ensure adherence of CSPV processes and procedures by internal personnel and external vendors.
Support conduct of inspections and audits and closely collaborate with Global GCP/PV-QA audit department in preparation of internal audits and regulatory inspections including preparation, review and provision of relevant documents; assigning roles and responsibilities for each audit/inspection.
Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures.
Collaborates with members of inspection team and other colleagues including Quality Assurance to ensure optimum responses to audit/inspection findings.
Responsibilities Continued Training Program: Takes a lead role in the development and enhancement of CSPV training programs based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training.
Training Plan and Delivery: Mentors instructors, subject matter experts and supervisors in techniques and skills for conducting effective training for staff, as needed.
Oversees the quality and consistency of training conducted within CSPV.
Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training.
Resolves and responds to training issues and questions.
Training Records and Maintenance: Monitors training compliance, and coordinates escalation of non-compliance.
Works with LMS Administrator to generate/access necessary training reports and to ensure proper training documentation.
Responsible for the implementation and maintenance of the Global Training Matrix for CSPV and leading related process improvements, as necessary.
Supports the annual roll-out of the Adverse Event Reporting Policy Training assigned to all company staff globally, which includes project management, facilitation of updates to the training content, evaluation of training adequacy, and appropriate distribution of training (with technical support from the LMS Administrator for LMS assignments).
Ensures training processes and relevant materials are up-to-date.
May participate in creation, review, and revisions to controlled documents and procedures.
Procedural Document Management: Procedural Document Program: Takes a lead role in the development and enhancement of a procedural and standards program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
Drives the strategic direction for documentation control including retirement schedules, file structures, delivery mechanisms (instructional, LMS, etc.).
Coordinates training curriculum for each function within CSPV and ensures the appropriate documentation is contained within the training profile.
Procedural Document Development and Delivery: Takes a lead role in the development of CSPV-related policies, procedures, operating guidelines including but not limited to SOPs, SOIs, guidance documents, associated forms and templates).
Works closely with CSPV management, SMEs and other functions as applicable to develop SOPs, SOIs and Guidance Documents.
Strives to ensure the process is optimized for efficiency and clarity.
Supports process redesign initiatives by updating relevant documentation for changes to processes.
Procedural Document Records and Maintenance: Maintains all documentation files, including forms and templates and communicates updates/revisions to documents.
Responsible for inspection readiness activities related to documentation.
Supports all internal and external partner audits for documentation requirements.
Qualifications Education Qualifications Bachelor's Degree, preferably in healthcare or life sciences, required Master's Degree, PharmD, RN preferred Experience Qualifications 4+ years of Pharmacovigilance experience in a pharmaceutical, biotechnology or related environment required.
7+ years total pharmaceutical industry experience in one or more of the following areas: Drug Safety/Pharmacovigilance, Epidemiology, and Clinical Development preferred 4+ years of direct experience in Pharmacovigilance Compliance, global setting preferred Possesses strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines preferred Daiichi Sankyo, Inc.
is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range: USD$124.960,00
- USD$187.440,00 Download Our Benefits Summary PDF
With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary This position supports the Associate Director, PV Quality & Compliance, PV Quality Management in the establishment, implementation, and oversight of the CSPV Quality, Compliance and Training function.
This position is responsible for managing activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance reports relative to safety reporting processes and regulatory authority submissions.
This role is the primary CSPV contact for Good Clinical Practice (GCP) and Pharmacovigilance (PV) inspections conducted by global Health Authorities/Regulatory Authorities (HAs/RAs) and PV audits conducted by DS Quality Assurance and License Partners/Affiliates, as applicable.
This position is responsible for facilitating audit and inspection-related activities within CSPV and supports the development of inspection readiness initiatives.
This position is responsibility for identifying training needs for CSPV staff and developing and overseeing training to ensure awareness of and compliance with organizational objectives and global laws and regulatory requirements.
With support from the Associate Director, PV Quality & Compliance, PV Quality Management, this position will take a lead role in the design, development, and coordination of training programs based on corporate, organizational and individual needs, collaborating with CSPV management and cross-functionally to ensure training needs are met.
This position is responsible for the design and development of a procedural document management program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
This position liaises with CSPV management and cross-functional teams as necessary throughout the corporation to drive a culture of regulatory compliance and ensure effective and efficient management of CSPV activities.
Job Description Responsibilities Quality and Compliance: Manages activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance metrics reports relative to the safety reporting and regulatory submission of individual case safety reports (ICSRs) and aggregate periodic safety reports.
Drives and manages an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis, root cause analysis and implementation of process improvement measures and effectiveness checks.
Leads audit/inspection readiness activities including but not limited to conducting routine/periodic quality assurance assessments to measure and ensure adherence of CSPV processes and procedures by internal personnel and external vendors.
Support conduct of inspections and audits and closely collaborate with Global GCP/PV-QA audit department in preparation of internal audits and regulatory inspections including preparation, review and provision of relevant documents; assigning roles and responsibilities for each audit/inspection.
Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses (pending and final) and resulting measures.
Collaborates with members of inspection team and other colleagues including Quality Assurance to ensure optimum responses to audit/inspection findings.
Responsibilities Continued Training Program: Takes a lead role in the development and enhancement of CSPV training programs based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training.
Training Plan and Delivery: Mentors instructors, subject matter experts and supervisors in techniques and skills for conducting effective training for staff, as needed.
Oversees the quality and consistency of training conducted within CSPV.
Collaborates with relevant functions and management for new staff on-boarding and general safety reporting training.
Resolves and responds to training issues and questions.
Training Records and Maintenance: Monitors training compliance, and coordinates escalation of non-compliance.
Works with LMS Administrator to generate/access necessary training reports and to ensure proper training documentation.
Responsible for the implementation and maintenance of the Global Training Matrix for CSPV and leading related process improvements, as necessary.
Supports the annual roll-out of the Adverse Event Reporting Policy Training assigned to all company staff globally, which includes project management, facilitation of updates to the training content, evaluation of training adequacy, and appropriate distribution of training (with technical support from the LMS Administrator for LMS assignments).
Ensures training processes and relevant materials are up-to-date.
May participate in creation, review, and revisions to controlled documents and procedures.
Procedural Document Management: Procedural Document Program: Takes a lead role in the development and enhancement of a procedural and standards program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
Drives the strategic direction for documentation control including retirement schedules, file structures, delivery mechanisms (instructional, LMS, etc.).
Coordinates training curriculum for each function within CSPV and ensures the appropriate documentation is contained within the training profile.
Procedural Document Development and Delivery: Takes a lead role in the development of CSPV-related policies, procedures, operating guidelines including but not limited to SOPs, SOIs, guidance documents, associated forms and templates).
Works closely with CSPV management, SMEs and other functions as applicable to develop SOPs, SOIs and Guidance Documents.
Strives to ensure the process is optimized for efficiency and clarity.
Supports process redesign initiatives by updating relevant documentation for changes to processes.
Procedural Document Records and Maintenance: Maintains all documentation files, including forms and templates and communicates updates/revisions to documents.
Responsible for inspection readiness activities related to documentation.
Supports all internal and external partner audits for documentation requirements.
Qualifications Education Qualifications Bachelor's Degree, preferably in healthcare or life sciences, required Master's Degree, PharmD, RN preferred Experience Qualifications 4+ years of Pharmacovigilance experience in a pharmaceutical, biotechnology or related environment required.
7+ years total pharmaceutical industry experience in one or more of the following areas: Drug Safety/Pharmacovigilance, Epidemiology, and Clinical Development preferred 4+ years of direct experience in Pharmacovigilance Compliance, global setting preferred Possesses strong knowledge of Food and Drug Administration (FDA), European Union (EU), and International Conference on Harmonization (ICH) guidelines preferred Daiichi Sankyo, Inc.
is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range: USD$124.960,00
- USD$187.440,00 Download Our Benefits Summary PDF
Not Specified
H
CRNA / Anesthesiology / New Jersey / Locum Tenens / Locums CRNA Job in New Jersey
Salary not disclosed
Locum opportunity for a CRNA in New Jersey Coverage dates: 5/23/2022
- Ongoing Schedules are Monday-Friday; 7am-3:30pm, 7am-5:30pm, 7am-7:30pm.
CRNA does not have to do OB, however the ability to do anesthesia for c-sections is a plus.
No call.
No weekends.
The candidate must be board certified and licensed in NJ.
The CRNA must also possess a CV, EPA, and CRNA Skill.
Located near Liberty Corner,NJ If you are interested in hearing more about this opportunity, please call or text MD Staff at (4
You can also reach us through email at
Please reference Job ID # j-60361.
Not Specified
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