Director, Clinical Quality Assurance
Eisai job in Nutley, NJ
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Director, Clinical Quality Assurance
The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).
Essential Functions
· Independently conduct audits
· Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits
· Facilitate Sponsor health authority inspections of global clinical facilities and study sites
· Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs
· Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies.
· May be responsible for direct people management including goal setting, performance management, development, and engagement.
Requirements
· Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area.
· 5+ years of experience in GCP auditing.
· Substantial experience in inspection management.
· Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials.
· Demonstrated ability to operate and influence decision-making processes
· Effective communication skills
· Successful track record of supervising employees and managing cross-cultural differences
· Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
· Knowledge of data integrity controls and systems quality for clinical area
· Strong analytical skills and report writing skills
· Experience with GxP systems including computer system validation and associated regulations, recommended.
· Ability to Travel (approximately 20%)
·
Candidates near Eisai's NJ/PA location will be preferred.
For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities.
Eisai Salary Transparency Language:
The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ***********************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplySr. Oncology Sales Specialist- S2 - (Brooklyn, NY)(field based)
Eisai Us job in New York, NY
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology therapeutic products within an assigned territory in a compliant and appropriate manner. The Senior Oncology Sales Specialist represents and promotes assigned brand(s) in the IV and oral markets with approved indications, helping targeted customers, such as Medical Oncologists, Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with office management to provide various informational resources, such as product data, and builds appropriate relationships with key personnel. Understands managed markets to understand product access and partners with appropriate reimbursement/market access partners. Key job activities include territory and market analysis, strategic business planning, self-driven execution of plans, meeting with key stakeholders, adapting quickly to internal/external changes in business and proactively driving local solutions. Collaborates appropriately with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and other specialty roles to facilitate aligned, coordinated efforts with Customers in a compliant manner.
Responsibilities:
* Responsible for meeting/exceeding Oncology sales goals for an assigned territory by promoting Oncology therapeutic products in a compliant and appropriate manner.
* Collaborate with leaders and relevant cross-functional teams to develop and implement territory business strategies and drive pull-through sales within Integrated Delivery Networks.
* Conduct ongoing territory and market analysis to monitor customer needs and preferences, and local market dynamics and trends.
* Identify, build relationships with, and influence prescribers and decision-makers through understanding of issues and opportunities in territory.
* Deliver clinical, efficacy, and safety messaging and information about product access / safe administration to relevant customer stakeholders in a compliant way.
* Monitor operating costs and compliance with territory budget.
* Seek out mentorship to learn and build key sales skills.
Qualifications:
Specialist- Oncology
* Bachelor's degree with minimum 2+ years of relevant experience in specialty sales experience in device sales or related therapeutic area (Oncology sales experience preferred).
* Experience in hospital and large account sales, and documented history of successful sales performance in a competitive environment preferred.
* Experience working with relevant customer business, disease state, product prescribing information, approved promotional clinical trials, patient access to medication, and regulatory/compliance guidelines preferred.
* Experience with account planning and management preferred.
* Experience working with key laws and regulations impacting the pharmaceutical industry (e.g., PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Statute; False Claims Act, OIG/DOJ Guidance; Foreign Corrupt Practices Act; and federal and state transparency and disclosure laws) preferred.
* Demonstrated skills at building and maintaining professional relationships with key customers and others in the customer influence network, preferred.
* Experience in business analytics to understand and analyze business and market drivers, preferred.
Sr. Specialist- Oncology
* Minimum 3+ years of relevant experience in specialty sales experience in device sales or related therapeutic area (Oncology sales experience highly preferred).
* Proven track record in successfully managing/overseeing sales portfolio within territory.
* Demonstrated success in planning/revising tactics within territory to align with external trends, market opportunities, and competitor landscape.
* Proven performance as a Specialist and fulfillment of defined promotion criteria.
As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Clinical Acumen (Oncology), Critical Thinking & Agility, Focus On Customers & Partners, Sales Ops & Data Analytics, Sells Effectively & Makes Impact, Territory/Account Management
Eisai Salary Transparency Language:
The annual base salary range for the Sr. Oncology Sales Specialist- S2 - (Brooklyn, NY)(field based) is from :$144,600-$189,700
Under current guidelines, this position is eligible to participate in : Eisai Inc. Sales Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyAccount Specialist, Customer Operations & Order Management
Woodcliff Lake, NJ job
**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
** Summary**
The Customer Operations Account Specialist - Order Management is responsible for order management activities in accordance with departmental policy and corporate goals. Executes daily order processing and coordinates logistics activities with Company's Distribution Center(s).
**Job Description**
+ Customer Order Management
+ Reviews all open orders based on customer ordering patterns and identifies exceptions based on high level customer and product trends
+ Makes suggestions for improved ordering with Account Executives Customer Management to ensure purchase orders are received and released to Par's Distribution Center (DC) in the most efficient manner
+ Review items in short supply with other Account Executives and management to manage product allocations in the system based on business objectives
+ Maintain inventory reserves via monthly recommendations from management
+ Executes in SAP as it relates to Customer Service and Operations including monitoring and fixing IDOCS
+ Communicates and monitors all priority orders
+ Works closely with distribution center on inventory and order issues
+ Releases orders to the distribution center in a timely manner
+ Serves as a back up to the Senior Account Specialist, Customer Operations & Order Management Validates REMS certification on specialty products prior to release to 3PL
+ . Forwards appropriate inquiries and exceptions to medical information group as needed
+ System Management
+ Coordinate and execute Electronic Data Interchange (EDI) and manual order entry process into the automated SAP ERP System
+ Review systems generated audit reports and performed all necessary corrections to sales order files.
+ Support various departmental initiatives such as DSCSA, creation of reporting, testing and validation of potential system enhancements.
+ Reporting
+ Customer Management back up - Maintain proficiency in customer focused information including Ordering schedules and delivery requirements
+ Support product launches and special promos by maintaining the New Product Launch tracking document. Ensure timely communication of updates to key business units
Qualifications
Education & Experience
_Minimal acceptable level of education, work experience and certifications required for the job_
+ Bachelor's degree required.
+ 2+ years' pharmaceutical experience
+ Experience with, Hyperion Essbase and ERP systems a plus.
Knowledge
_Proficiency in a body of information required for the job._
_e.g., knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._
+ Proficient in Microsoft Office
+ Proficient in SAP
+ Knowledge and familiarity with Supply Chain processes preferred
Skills & Abilities
_Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g., coaching, negotiation, calibration, technical writing_ _etc._
+ Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
+ Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
+ Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.
+ Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
+ Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Must be results-oriented with excellent planning, process, and execution skills.
+ Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs.
+ Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
+ Must be proficient in communicating and interacting with all levels of management as well as outside organizations.
+ Flexibility in adjusting and reprioritizing to meet changing needs in a fast-paced work environment.
+ Ability to manage various customer requirements simultaneously including deadline sensitive priorities.
+ Team player possessing a strong work ethic and drive for results.
Physical Requirements
+ General office environment
+ After-hours work may be occasionally required
The expected base pay range for this position is $70,000 - $90,000. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.
This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion.
**EEO Statement:**
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Study Delivery Lead (SDL)
Ridgefield, NJ job
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary:
The Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the accountability for 1 or several complex studies in various settings including Phase I-III, within a delivery model comprising of outsourced studies or outsourced studies with elements of insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Health Authority regulations, International Conference on Harmonization (ICH) guidelines and local regulations, as required. The SDL is accountable for operational planning and execution at the study level with responsibility for clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget. The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate with the core and extended team to ensure robust CRO oversight including 3rd party vendors to achieve study milestones and deliverables according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics, Analytics, Reporting and Solutions (MARS) team to drive and monitor progress. The SDL fosters an environment where the core study team maximizes their expertise and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other governance level as needed The SDL will have regular interactions with key internal and external stakeholders to discuss project status, escalate issues, and troubleshoot inquiries. For this role, strong written and verbal communication skills in English, operational leadership, and decision-making, ability to delegate, strategic thinking, conflict resolution, clinical project management experience and attention to detail are required. The SDL is an experience matrix leader and serves as a mentor to more junior colleagues on clinical trial execution. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations. The SDL is the reference and role model within the study delivery lead team that drives the culture for a healthy team. The role is primarily responsible for Operational Study Strategy and Study Execution while exhibiting leadership qualities.
Responsibilities:
Lead the core study team while project managing and collaborating with internal stakeholders to ensure cross functional integration and delivery of study milestones (e.g. protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.)
Ensure operational study-level timeline, budget, deliverables and quality management.
Facilitate escalation and resolution of issues with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead).
Where appropriate, may delegate certain responsibilities to Study Manager(s) assigned to the study Protocol Development, and Team Assembly-Contribute to and interface with different levels of study governance, as required
Oversee the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies).
Provide operational input into concepts, CDP, study protocol profiles, final protocols and amendments
Participate in protocol and amendment review. Contribute to the development of and oversee delivery timelines of ICF, IB and safety communications, DSUR, IND.
Partner with other functional leaders to address core study team gaps and ensures accurate and complete study team list is maintained.
In partnership with the lead physician, Clinical Scientist and all study team members, accountable for the co-ordination and conduct of feasibility process for protocol development in alignment with the CDP/IEP.
Application of feasibility analysis to manage study implementation in the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery-Lead the CRO and vendor selection process and scope of work in collaboration with the study team and Procurement Management.
Lead trial feasibility and site identification and qualification activities in collaboration with the CRO, feasibility team and the study team.
Assist Data Management with development of the clinical database (edit checks, CCG development, and UAT)
Study Conduct and Oversight:
Ensure operational adherence to the clinical study oversight plan-Reinforce CRO/Vendor accountability for trial execution and quality data delivery. Foster a culture of empowerment and accountability for CRO to resolve study issues internally, raising such for DS action per exception/defined criteria for escalation-Monitor clinical trial performance and quality metrics and share with study team and GPT on regular basis and ensure actions are taken (at the study team level and CRO and vendors levels) and/or issues / risks are escalated to project team level and relevant governance bodies-Lead escalation and resolution of issues with CRO/ vendors/ site/ country performance including serious quality incidents and serious breaches of GCP. Triage, resolve or escalate study issues /risk mitigations as per JOC/ESC and other established forums. The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the absence of Asset Lead).
Monitor study budget against trial progress and Inform Finance of deviations-Review and approve Vendor invoices, including investigator grants and pass through costs.
Quality and inspection readiness:
Support inspection readiness and quality initiatives pertaining to assigned study(ies).
Serve as primary SME engaged in dialogue with inspector(s) to address study inquiries throughout course of HA inspection-Ensure trial master file is complete and accurate for assigned stud(ies).
Ensure that a study level operational risk management plan is in-place and applies a smart-risk taking philosophy.
Responsible for the delivery, oversight, performance and management of 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education:
Bachelor's Degree In Life Sciences field and a minimum of 7 years relevant experience required
Experience:
Experience in global clinical operations methods and processes in industry setting is required
Experience considered relevant includes clinical or basic research in a pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), hospital/medical setting or Contract Research Organization (CRO). Clinical Project Management experience required. required
CRA experience is preferred
Familiarity with a Japan-based organization is beneficial preferred
Travel:
Ability to travel up to 10%
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:
$168,000.00 - $252,000.00
Download Our Benefits Summary PDF
Auto-ApplySenior Associate SP&L
Ridgefield, NJ job
Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary:
This is an operational position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of role, and/or complexity. This position has strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.
Has sufficient knowledge to identify critical issues or problems with projects and/or identification of issues which may compromise patient dosing or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized and the need for CAPAs or reports on deviations is clearly understood. Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address such issues or concerns. Experience with IRT systems and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross functional and on Global teams.
Responsibilities:
Works, under supervision, with outsourcing to submit appropriate requirements on a project basis. Supports team in generating RFPs and in reviewing proposals and selecting vendors. This position also supports the management of the WO development and implementation.
Supports packaging design and patient kit supply preparation, label generations and approvals and associated interactions with vendors. Supports regular vendor/sponsor discussions to identify risks and ongoing study support. Identifies critical issues which may compromise patient dosing or safety. Supports comparator sourcing requirements, RFP generation and working with outsourcing to submit appropriate requirements on a Project basis.
Vendor Management - support interactions with Vendors on packaging design and patient kit supply preparation, label generations and approvals. Support regular vendor/sponsor discussions to identify risks and ongoing study support.
Ensures on time site shipments for subject and patient dosing, and ensures that material is fully released prior to shipment to site
Ensures compliance with all domestic and foreign regulatory requirements but may seek line management support when necessary. Basic knowledge of Import/export requirements to the extent that there is overall recognition of potential global issues as regards import license requirements, shipment delays and is able to communicate the issues and support resolution development.
Support IRT design for control of drug dispensing and inventory management. Understand User specifications in support of IRT processes and basic concepts of IRT
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)
Bachelor's Degree required
Master's Degree preferred
Experience Qualifications
4 or More Years related professional experience required.
Must have professional experience Project Management, Clinical Supply Management, and/or Clinical Trials Coordination
Demonstrated experience in working in any of these areas: inventory management, forecasting, and distribution of drug supply needs, IXRS experience, managing vendors and contributing to budget control 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:
$99,120.00 - $148,680.00
Download Our Benefits Summary PDF
Auto-ApplyAssociate Senior Counsel, Privacy
Eisai Us job in Nutley, NJ
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Associate Senior Counsel, Privacy, is a strategic, business-minded, and hands-on attorney role whose job will be to lead Eisai's privacy initiatives across the U.S. and Canada and partner with cross-functional teams to design and implement practical privacy solutions that enable the Company's innovation while protecting data and mitigating risk. The role requires deep expertise in privacy law, strong communication and interpersonal skills, and the ability to provide timely, practical guidance while driving rapid results. The ideal candidate is a proactive, collaborative and adaptable professional who is comfortable working in a fast-paced environment, able to balance legal risk with business needs, communicate complex issues in relatable terms, and embed privacy into Eisai's business strategies.
In expanding and managing Eisai's U.S. Privacy Program, the responsibilities of the Associate Senior Counsel, Privacy, include, but are not limited to, practical and timely counseling on privacy issues involving personal data (e.g., PII, PHI, consumer health information), partnering with business groups to identify and execute privacy solutions for priority initiatives and daily business activities, developing and updating privacy policies and procedures, conducting privacy risk assessments and privacy-related investigations and implementing any resulting mitigation and/or remediation plans, supporting cross-functional teams on information governance, partnering with Legal and other cross-functional colleagues to provide guidance and support on Artificial Intelligence (AI) initiatives and governance, and conducting company-wide privacy training and awareness initiatives.
The Associate Senior Counsel will also be expected to support the HR team on employee benefits issues, including counseling on privacy issues arising from benefits administration, negotiation of vendor agreements, and development and implementation of a governance framework.
Responsibilities
Privacy (80%)
* Counsel and support business teams across the organization (Sales, Marketing, Medical, Market Access, Corporate Advocacy, HR, IT, Data Governance, Government Affairs, R&D, etc.) in executing both high-priority strategic initiatives (e.g., data-driven platforms, AI, digital patient and HCP-facing projects, omnichannel activities, targeted advertising, etc.) and daily business activities in compliance with state, federal and global privacy laws.
* Draft, review, update and negotiate privacy-related agreements, consents, disclosures, and notices.
* Support development and implementation of privacy policies and guidelines, including AI governance, data use protocols and digital playbooks.
* Conduct privacy risk assessments (e.g., website cookie audits, state-required risk assessments for initiatives involving Personal Information) and develop, execute, and manage the creation and completion of mitigation and remediation plans.
* Lead or support internal investigations and assessments related to data privacy and security.
* Counsel on privacy-related issues arising from commercial and medical review committee submissions.
* Advise on cross-border data transfers (e.g., clinical data) and collaborate with global privacy counterparts to ensure compliance with international frameworks (e.g., GDPR, PIPEDA) and alignment on enterprise-wide privacy initiatives.
* Participate in and/or support internal governance committees (e.g., regional AI Committee) to provide legal input on privacy and data ethics.
* Manage consumer requests for personal data inquiries per applicable regulations (e.g., CCPA)
* Deliver privacy training and awareness programs across the organization (e.g., Privacy Day/Week).
* Monitor regulatory developments and assess their impact on business operations.
* Collaborate with Government Affairs colleagues to proactively address public policy matters involving privacy.
Benefits (20%)
* Counsel and support the HR team on HIPAA compliance and broader regulatory obligations (including ERISA, COBRA, and ACA) as they intersect with privacy and data handling in the administration of the Company's benefits programs.
* Provide legal guidance on employee data privacy in the context of benefits administration (e.g., wellness programs, third-party platforms).
* Coordinate with HR and IT to ensure secure handling of PHI in benefits programs.
* Draft, review, update and negotiate benefit vendor agreements.
* Support development and implementation of governance framework for benefits programs.
Requirements
* J.D. from an accredited law school and admission to practice law in any U.S. jurisdiction (as evidenced by a Certificate of Good Standing).
* 7+ years as a practicing, licensed attorney with high-level client contact and responsibility, with 4-6 of those years focused on privacy counseling (preferably in the pharmaceutical/biotech industry).
* Deep knowledge and experience advising on applicable state, federal and international privacy laws.
* Experience advising on privacy issues relating to digital health initiatives, online advertising and cookie compliance.
* Demonstrated ability to act independently with urgency, work in a fast-paced environment, juggle multiple high-priority items, manage client expectations, and timely deliver strategic advice.
* Demonstrated curiosity and adaptability, with a willingness to take on new and unfamiliar topics, learn quickly, and step outside of one's comfort zone to deliver results.
* Strong problem-solving and analytical skills - demonstrates expert understanding and analysis of the issues and exercises creativity and initiative when offering solutions.
* Strong interpersonal skills with the ability to build relationships across teams; enjoys collaboration and thrives in a role that requires frequent live interaction and engagement with stakeholders.
* Team player who can work cross-functionally in a complex organizational structure and deepen their business acumen.
* Strong written and verbal communications skills - able to clearly communicate with client groups at all levels of the company in a way that makes privacy relatable and tailors the message to the audience, whether in daily counseling or in delivering presentations.
* Strong drafting and negotiation skills.
* Strong project management skills such as scheduling, planning, and prioritizing a variety of activities, initiatives, and projects from different individuals, groups, or departments.
* Individual will partner with and receive strategic guidance from manager, but must be comfortable managing priorities and taking ownership of end-to-end execution as a team of one.
* Proficient technology skills.
* Work in-person at the Company's New Jersey office Tuesday through Thursday every week.
If not licensed to practice law in New Jersey, selected candidate must obtain a limited law license pursuant to New Jersey Court Rule 1:27-2.
Skills:Business Acumen, Communication & Cross-functional Influence, Critical Thinking & Business Agility, Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management, Legal Knowledge, Mentoring/ People Development, Stakeholder Management (Legal/ Compliance)
Eisai Salary Transparency Language:
The annual base salary range for the Associate Senior Counsel, Privacy is from :$189,100-$248,200
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyDirector, Clinical Pharmacology
Eisai job in Nutley, NJ
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Director, Clinical Pharmacology actively contributes to multi-disciplinary teams by providing innovative and progressive thinking on projects and where appropriate, offers guidance to other team members.
In addition to possessing the scientific expertise, the incumbent must be capable of analyzing and interpreting study data and effectively communicating findings to a broad audience. The Director, Clinical Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to provide sound input on Clinical Pharmacology activities to a variety of project teams.
Essential Functions
Directs and Implements clinical pharmacology plans and programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)
Leads the development of Clinical Protocols to meet CDP objectives.
Serves as Study Director/Clinical Pharmacology Lead and drives the execution of the study from protocol concept to final report including interpretation of clinical data.
Serves as Medical Monitor (where applicable) to review and monitor study data.
Implements strategies to identify, monitor and resolve clinical program/trial issues.
Interprets study data and develops integrated summaries of Clinical Pharmacology data as it relates to safety and efficacy.
Contributes to Clinical Pharmacology expertise and content to regulatory documents (e.g. briefing books, INDs, NDAs etc.) and represent Clinical Pharmacology in discussions with Health Authorities.
Reviews 3rd party work products and deliverables to approve payment of invoices and resolve discrepancies.
Requirements
A PhD, MD or PharmD degree with at least 5 years of pharmaceutical industry related experience as a Clinical Pharmacology Project Lead.
A thorough understanding of global regulatory requirements on the Clinical Pharmacology and Translational Medicine aspects of drug development.
A thorough understanding of standard Clinical Pharmacology computational programs.
Experience in oncology, pediatric development and translational medicine is preferred but not required.
Strong inter-personal skills are required since the job requires substantial interaction within the assigned Business Group as well with other Pre-clinical, Modeling, and Translational Science Groups.
Complies with all applicable laws/regulations of each country Eisai does business in.
Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients or physicians.
Minimal travel required: less than 10%
Eisai Salary Transparency Language:
The base salary range for the Director, Clinical Pharmacology is from :200,200-262,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ***********************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyPharmaceutical Sales - Associate Territory Manager - Cardiometabolic Health
Great Neck, NY job
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Territory Manager - GREAT NECK, NY CMH2_170879
The Territory Manager will be accountable for account-based selling to health care providers (HCPs) who prescribe and influence the treatment for the disease states represented in the Lilly portfolio. This includes customers in multiple HCP specialties, as well as representatives in key hospital accounts. They will be viewed as a credible expert and resource supporting all medicines and appropriate brand patients.
The Territory Manager will be accountable for driving results by embracing Lilly's suite of models: Lilly Selling Model, Lilly Competency Model and Account Management Model to meet the needs of customers through strong execution. Territory Managers will drive consistent ways of working within the Regional Healthcare Market. They will build relationships with key customers to drive utilization and adoption of our medicines for the right patients. Specific responsibilities include the following:
BUSINESS OWNERSHIP
• Promotes the full portfolio of priority products with multiple HCP specialties.
• Understands the marketplace within the territory; evaluates and tailors the territory strategy to grow and own business outcomes.
• Navigates the ever-changing healthcare environment and payer landscape to increase understanding of accounts and be able to impact key stakeholders to become trusted partners.
• Utilizes appropriate business insight tools, data, and analytics to identify trends, priorities, opportunities, and potential obstacles.
• Implements and adopts new technologies, including the integration of AI company-approved tools and other analytical capabilities to streamline customer interactions.
• Identifies and advocates for new opportunities to enhance the customer experience.
• Models a growth mindset to create positive experiences.
SELLING SKILLS / CUSTOMER EXPERIENCE
• Embraces and uses the company's selling, competency and account management models to elevate performance and drive results.
• Demonstrates high learning agility to understand disease state, marketplace, clinical trials, and product label.
• Promotes the BU portfolio by planning for and engaging in patient-centered dialogues with customers.
EXECUTION / RESULTS
• Promotes across BU-portfolio and across HCP specialties, driving consistent ways of working within the Regional Health Care Market to meet customers' needs. Appropriately, fully utilizes the Virtual Medical Hub.
• Achieves targeted sales and execution metrics while adhering to company policies and procedures.
• Owns the customer relationship for product promotion, on-label medical questions, and general market access.
• Holds self-accountability for results and performance across all accounts, from individual HCPs to large health systems.
• Builds and maintains relationships with both internal and external partners to foster trust and create collaborative success.
BASIC QUALIFICATIONS
• Bachelor's degree.
• Professional certification or license required to perform this position if required by a specific state.
• Valid US driver's license and acceptable driving record is required.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.
ADDITIONAL SKILLS / PREFERENCES
• Demonstrated business ownership skills, selling/customer experience skills, and execution/results.
• Account based selling experience. Ability to identify and engage staff members in accounts.
• Strong learning agility, self-motivation, team focused, and emotionally intelligent.
• Bilingual skills as aligned with territory and customer needs.
• Residence within 30 miles of the territory boundary.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $151,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyAssociate Director, Program Management and Operational Excellence
Ridgefield, NJ job
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Associate Director, Global Oncology Medical Affairs, Program Management & Operational Excellence will provide program management support across all the Medical Affairs functions that are working on a launch, approved products or earlier assets to assure consistent planning, execution, tracking and reporting of activities in accordance with Medical Affairs strategy and objectives. This includes assuring appropriate planning, execution, tracking and reporting activities with cross-functional partners and if applicable, Alliance counterparts.
Responsibilities
- Partners with Global Oncology Medical Affairs and stakeholders in Daiichi Sankyo to manage the creation of the product specific Medical Strategy and Objectives. Collaborates with all Medical Affairs functional owners to define and maintain a detailed project plan in alignment with overall Medical Strategy and Objectives. Support in implementing operational and working standards in support of the product, including governance, meeting cadence, decision making procedures and communication. Closely monitors and provides regular reports on the progress of Medical Affairs activities; identifies risks and issues to the overall strategic and tactical plan. Manages budgets and vendor/agency activities as needed and provides regular reporting on budget and financial metrics
- Supports the Director, Program Management Operational Excellence to align on Medical Affairs activities with the overall Tumor Strategy and/or Brand Management plan including cross-functional deliverables jointly owned by departments such as Marketing and Market Access. Builds slide decks, dashboards, and Medical Affairs project communications
- Defines meeting agendas, facilitates meetings, and issues meeting minutes. When applicable works with an Alliance counterpart to assure effective collaboration across both organizations
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)
- PhD with appropriate relevant pharmaceutical experience preferred or
- PharmD with appropriate relevant pharmaceutical experience preferred
- Bachelor's Degree required
- Master's Degree preferred
Experience Qualifications
- 7 or More Years overall related experience or commensurate education/experience required
- 4 or More Years relevant medical affairs experience with strategic experience 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:
$159,440.00 - $239,160.00
Download Our Benefits Summary PDF
Auto-ApplyExecutive Director, Clinical Data Science
Eisai job in New York, NY
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Job Description Summary
We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards.
Strategic Leadership:
Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio.
Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives.
Innovation & Execution
Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine.
Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices.
Risk Management & Problem Solving
Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges.
Thought Leadership & External Engagement
Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices.
Team Leadership & Development
Manage and mentor a diverse team of data scientists and people managers across geographies.
Foster career growth through open dialogue, performance management, and strategic development planning.
Operational Excellence
Ensure GxP compliance in data science programming for clinical trials.
Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency.
Executive Communication
Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence.
Qualifications
Ph.D. in Biostatistics, Bioinformatics, or related computational sciences.
Deep expertise in statistical methods and their application in clinical trials.
Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics.
Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine).
Proven experience presenting at external forums and influencing regulatory authorities.
Strong people leadership experience in a Data Science setting.
Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred.
Eisai Salary Transparency Language:
The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplySenior Medical Affairs Administrative Assistant
Eisai job in Nutley, NJ
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Senior Medical Affairs Administrative Assistant will support Medical Affairs Field Medical, Strategy & Operations, and Medical Communications teams. The incumbent will provide administrative support and coordination to the department and conduct contracting, invoicing and data entry to support department's projects. Essential Functions The Senior Medical Affairs Administrative Assistant will prioritize workload and deliver specific clerical/administrative activities and services under guidance from assigned manager(s).
Calendar management and coordination of meetings: setting up and attending virtual and internal meetings, working closely with the team on all aspects of meeting management: oversight of attendees, requesting agenda items and slides, running the slides during the meeting, taking high level meeting minutes, file management, and engaging with all functions to consolidate materials for meetings and deliverables, and meeting follow up, as needed
Manage end-to-end contract creation and submissions including compliance & IT/security assessments; procurement process; and creation, review and tracking of requisitions and purchase orders, and processing invoices.
Data entry support for Medical Affairs digital platforms and supporting AI technologies as needed
Assistance with managing department distribution lists and sending communications/ uploading shared files as needed
Review monthly medical social media channel content calendars
Coordinate domestic as well as international travel arrangements for department
Prepare expense reports
Assist with ad hoc projects under general guidance from manager(s)
Provide support to other members of the department as needed
Interact with staff at all levels in a fast-paced environment
Requirements
3+ years experience of administrative skills (5+ years preferred)
Bachelor's Degree in a science related field preferred
Prior experience in pharmaceutical or biotechnology industry preferred
Proficiency in MS Office Suite (PowerPoint, Word, Excel) Outlook, database software management, Adobe Acrobat, and internet search skills
Must be self-starter with the ability to multi-task
Proactive and able to anticipate next steps in work
Flexibility to accommodate to rapidly changing priorities and deadlines
High level of accuracy and attention to detail
Strong verbal and written communication skills
Strong customer service skills
Prior project coordinator and experience facilitating meetings a plus
Familiar with contracting / procurement process a plus
Hybrid work, with 3 days on site
Eisai Salary Transparency Language:
The hourly rate for the Senior Medical Affairs Administrative Assistant is from :$29-$38Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyDirector, Translational Pathology
Ridgefield, NJ job
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary:
The Director, Translational Pathology will work across the Translational Science matrix to develop and implement pathology-based translational approaches to assessing PD and patient selection biomarkers for Oncology and Specialty Medicine programs. They will further serve as the scientific expert supporting digital pathology investigations and as a point of contact for developing and managing external partnerships in support of translational science and CDx programs. They will provide the expertise to create and integrate pathology datasets with broader multi-omic analyses to support hypothesis-driven translational research efforts with direct impact across the Development continuum. They will work in a highly collaborative environment.
Responsibilities:
- Design and build internal digital pathology capabilities and support data generation for translational pathology evaluations across the portfolio. Develop and manage partnerships, largely focused on digital pathology, to support design and implementation of translational pathology plans.
- Lead development of the translational pathology strategic direction and support data generation for assigned assets, with a focus on the design and implementation of translational pathology plans.
- Provide expertise to the Daiichi Sankyo Global Research Development organization to ensure access to state-of-the-art thinking on appropriate translational pathology strategies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to proposed business plans.
- Communicate with portfolio leaders in Clinical Development, Discovery, QCP, CDx, RA, MA or other relevant functions to ensure effective integration of translational pathology strategy into broader Translational/Program strategies
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)
- MD or MD PhD with Anatomic Pathology board certification required.
Experience Qualifications:
- 5 or more years of post-doctoral and relevant industry experience with expertise in pathology-driven translational research, biomedical leadership and human translational research in clinical trials required
- Experience with digital/computational pathology technologies and translational research required
- Extensive experience in the discovery, characterization and utilization of innovative translational strategies across the continuum of preclinical and clinical stages preferred.
- Experience/knowledge in companion diagnostics device development preferred
- Demonstrated ability to define clear translational strategies anchored in disease biology and drug mechanism of action, aligned with clinical development required
- Deep knowledge in pathology-based and other biomarker technologies including immunohistochemistry (monoplex and multiplex), digital pathology, spatial analyses, NGS, immunoassay, proteomics including expertise in assay validation required
Travel: Ability to travel up to 10%. Global travel
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
$215,360.00 - $323,040.00
Download Our Benefits Summary PDF
Auto-ApplyAssociate Director, Global Oncology Medical Affairs, Medical Analytics
Ridgefield, NJ job
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Associate Director, Global Oncology Medical Affairs, Medical Analytics will be responsible for managing the digital analytics infrastructure and developing and executing analytical capabilities for the Medical Affairs function. This role will leverage advanced analytics, data science methodologies and various medical data sources and real-world evidence needed to support decision-making processes. This role will also oversee medical data governance to ensure appropriate data-use and analytical best practices. Innovative analytical methodologies led by the Medical Analytics Lead will be used to support key projects like Medical insights Mining, Care Gap Analysis, Medical Affairs Impact and Omnichannel strategy. This is a global role which will work across regions, functions and assets to identify and leverage synergies across analytics teams.
Responsibilities
- Data-Driven Insights Reporting and trend analytics: Lead the development and implementation of robust analytics frameworks, Gen-AI and NLP to analyze complex field medical engagement and other KEE engagement data to derive actionable insights for Medical Affairs. Partner with stakeholders to generate comprehensive reports and dashboards to communicate key findings and recommendations to internal stakeholders, including senior leadership and medical affairs teams. Ensure utilization of advanced analytics techniques to identify HCP sentiment trends, unknown/actionable insights, data gaps and potential actions
- Impact Measurement (Internal External): Partner with internal stakeholders to identify the data and design the visualization to measure and report medical affairs impact including execution, leading and lagging metrics that tie to the medical affairs strategy. Update the metrics in a regular cadence based on feedback from HCP interactions, patient outcomes and evolution of medical affairs strategy.
- Pilot Analytics projects: Evaluate technologies and platforms that support a minimal viable product for various Medical Affairs analytical initiatives related to Omnichannel Engagement, Evidence Planning and Care gap. Partner with technology teams on platform management and as pilots become successful, scale up initiatives into larger projects.
- Digital Initiative Assessment (e.g., Predicted vs. Actual): Evaluate the success and performance of digital/analytical initiatives by comparing predicted outcomes with actual results, identifying discrepancies and opportunities for improvement; develop and track metrics to evaluate impact of initiatives; partner with Operational Change Management team to develop change management strategy which will increase user adoption.
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)
- Bachelor's Degree , preferably in data science or related field, required
- Advanced degree - including PhD / PharmD, MD or related degree preferably in Oncology preferred
- MBA or other related degree preferred
Experience Qualifications
- 7 or More Years overall related experience or commensurate education/experience (with at least 5 of the minimum 7 years being relevant, professional level experience) required
- 4 or More Years of related experience working in data analytics in commercial, regulatory, market access or medical affairs function in a healthcare industry required
- 4 or More Years Experience managing analytics vendors and external data sources to enhance insights generation required
- 4 or More Years Experience with dashboarding and reporting tools like Tableau, Power BI and Looker required
- 1 or More Years Experience leveraging AI/ML technology to meet advanced analytical needs required
- Proficiency in SQL, Python, R, or other advanced analytical tools preferred
Travel
Ability to travel up to 20%
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:
$159,440.00 - $239,160.00
Download Our Benefits Summary PDF
Auto-ApplySenior Director, Head of Global Experienced Hire and Early Career Talent Acquisition
Ridgefield, NJ job
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary:
Leads the global design and implementation of experienced (below VP) and early career hiring strategies and designs policies, practices, and programs in accordance with our People philosophy.
Acts as a Global Business Unit Talent Acquisition Lead responsible for bridging strategic workforce planning and operational execution for assigned global business unit and/or function(s).
Lead a team of Global Business Unit Talent Acquisition Leads. Provides oversight and direction to the Heads of Regional Talent Acquisition to ensure global consistency where possible.
Participates in the Talent Acquisition global leadership team and acts as a key advisor to Global HR Leadership Team on experienced hire and early career matters. Scope of role includes Europe, Canada, United States and Japan and may include other regions/management units as needed to reflect changes to the business model.
Responsibilities:
Strategic Leadership:
As a member of the Talent Acquisition Leadership Team, contribute to the development of the Global Talent Acquisition strategy, policies and processes and define the experienced hire and early career hiring strategy that underpins this
Lead Global Business Unit TA Leads supporting them in achieving their goals, creating a positive work environment, encouraging motivation and performance, developing their skills and managing conflict
Design and implement recruiter capability building programs, including advanced talent identification strategies, candidate engagement techniques, data-driven decision making, and inclusive hiring practices.
Provide guidance and direction to Heads of Regional TA and the wider Experienced Hire and Early Career team members, driving consistency across processes, programs and regions
Allocate and manage the budget and human resources in the Global Experience Hire Early Careers TA team
Program Development and Standardization:
Establish and standardize experienced hire and early career recruiting, interviewing and hiring policies, tools and practices to provide a globally consistent experience, adapted to business needs and local regulations (e.g. intake forms, interview guides, recruiter playbooks)
Partner with hiring managers to define role requirements, competencies, and selection criteria
Lead the development of globally consistent early career programs such as internships, fellowships, and trainees, adapted to regional and business needs, to ensure a strong pipeline of early career talent
Define the global experienced hire and early career TA operating model including processes, tools, standards and the use of outsourcing, as needed
Operational Oversight and Coordination:
Ensure a seamless and engaging candidate experience, from application to pre-hire onboarding.
Oversee and coordinate cross-regional recruiting efforts or recruitment for global senior positions (below VP level)
Lead global talent acquisition projects and improved ways of working for both Experienced Hire and Early Career Talent Acquisition
Stakeholder Engagement and Collaboration:
Lead by example as a strategic talent advisor, modeling consultative stakeholder engagement and influencing hiring leaders on complex hiring needs.
Facilitate discussions with business leadership on how to prioritize recruitment efforts globally to most effectively support business needs and identify future workforce needs
Advise HRBPs and Talent Partners on recruitment matters related to global strategic workforce planning
Manage relationships with external vendors/partners (e.g., recruitment agencies) that support the delivery of experienced hire and early career programs and maintain global preferred supplier lists-Partner with the Employer Branding team to ensure consistent messaging of DS' employer brand in the market
Collaborate with Head of Global Talent Acquisition and Human Resource Information System (HRIS) team to define/implement program functionality requirements for global HRIS
Reporting and Improvement:
Oversee the monitoring and analysis of experienced hire and early career programs, identifying opportunities for improvement or to adapt to changing business priorities
Own Global Approved Headcount tracking and quarterly recruitment prioritization processes, working closely with Finance, Global HR and Global TA Business Unit Leads
Ensure accurate and timely hiring data for leadership quarterly reporting and forecasting-Facilitate periodic benchmarking and market-related research on experienced hire and early career TA methodologies and determine necessary policy/program changes to continuously enhance DS' offerings
Develop KPIs and other metrics to evaluate the impact of experienced hire and early career programs and direct periodic analysis to identify opportunities for improvements
Ensure that DS' experienced hire and early career TA practices support the company's commitment to inclusion and diversity
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education:
Bachelor's Degree required
Master's Degree preferred
Experience:
10 or More Years Relevant experience in experienced hire and/or early career talent acquisition or alternative relevant experience required
4 or More Years Managing direct reports required
4 or More Years Experience in full-life cycle experienced hire recruiting for pharma and/or biotech companies required
4 or More Years Leading global recruiting teams preferred
4 or More Years Experience in early career / university hiring for pharma and/or biotech companies preferred
4 or More Years Experience managing project delivery in global and/or multicultural collaboration preferred
4 or More Years Experience developing and implementing talent acquisition strategies and programs preferred
4 or More Years Technical knowledge of experienced hire and early career hiring trends and processes preferred
4 or More Years Understands latest experienced hire and early career hiring technology and systems preferred
4 or More Years Proven success in supporting rapid organizational growth through effective experienced hire and early career Talent Acquisition programs preferred
4 or More Years Knowledge of best-in-class experienced hire and early career hiring practices in key industry groups preferred
4 or More Years Use of data analytics to monitor and predict experienced hire and early career hiring future needs 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:
$197,925.00 - $329,875.00
Download Our Benefits Summary PDF
Auto-ApplyPharmaceutical Sales Specialist, Primary Care - Edison, New Jersey
Edison, NJ job
At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
Our ambition is to improve and save lives for the millions of people who are living with the complexities of Cardiovascular, Renal & Metabolic (CVRM) diseases. AstraZeneca is uniquely positioned to improve the outcomes of patients living with CVRM diseases today and tomorrow with our strong and expanding portfolio and one of the broadest, deepest, most innovative pipelines in the industry. By 2032, we intend to be leading the world in CVRM therapies, launching up to 15 new life-changing medicines.
To support our future growth, we have an exciting opportunity as a Primary Care Sales Representative to launch a best-in-class hypertension asset.
At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV.
As a Pharmaceutical Sales Specialist for the Primary Care Team, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives!
Accountabilities
Develop and demonstrate knowledge of clinical disease states and treatment guidelines.
Effectively communicate product information to healthcare professionals.
Execute call plans and Brand Strategy by translating data to actionable insights.
Adapt to and demonstrate a thorough understanding of AZ Selling Model.
Analyze data and trends to build insightful and actionable business plans for your assigned sales territory.
Build relationships and credibility with Primary Care healthcare professionals to effectively position products by establishing unmet needs, clinical differentiation, and fair balance of our Brands.
Leverage multiple channels including digital platforms and face-to-face engagements to drive meaningful customer interactions.
Open to receiving guidance and seek insights for growth and development.
Essential Skills/Experience
Bachelor's Degree
0 - 2+ years of demonstrated Sales or B2B, or Commercial experience
A valid driver's license and safe driving record
Essential Skills and Capabilities
Customer Focus: Strong customer relationship management skills with the ability to understand and address customer needs.
Business Acumen: Ability to analyze and interpret complex data to develop strategic sales plans.
Technical Aptitude: Proficiency in using digital tools and platforms to engage with healthcare professionals.
Adaptability: Flexibility and adaptability to changing market conditions and customer needs.
Collaborative: Ability to work effectively in a team environment and collaborate with cross-functional teams.
Desirable Skills/Experience
Experience selling to general practitioners (GPs) and primary care centers
In-depth understanding of the healthcare industry and primary care operations
At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We shape the future by spotting scientifically-led commercial opportunities and acting now to operationalize and scale them. Driven by the solutions we bring to the healthcare ecosystem, we make an impact at every step of the patient journey, improving their experience and outcomes. Our team thrives on energy and pace, constantly thinking big to answer new challenges. We lead Commercial to provide solutions that make a difference, improving our patients' experience and health outcomes.
The annual base pay (or hourly rate of compensation) for this position ranges from $76,935 to $177,882. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
10-Dec-2025
Closing Date
01-Jan-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Auto-ApplyDirector, Omnichannel Marketing
Ridgefield, NJ job
Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary:
The primary responsibilities of the Director, Omni-Channel Marketing is to develop, plan and implement the overall omni-channel marketing strategy to key customer segments across the portfolio in partnership with brand teams. The incumbent should assess external digital opportunities and threats as key inputs to decisions on business strategy given market dynamics. The Director should ensure smooth execution of all digital platforms, tools and applications, including but not limited to websites, virtual presentations and social media. The individual will Measure ROI and KPIs and assess need for enhanced investments and innovative platforms. The Director will also ensure effective deployment of core media strategies and management of media AOR.
Responsibilities:
Support value proposition creation of the Daiichi Sankyo marketed products for customers, by identifying gaps, trends and opportunities for success across all channels. Assess challenges and opportunities and/or organizational dynamics to proactively employ appropriate actions to quickly deploy technologically advanced tools, resources to optimize customer 360 experience and reaffirm brand messaging, positioning and any patient materials (as needed). All digital solutions should augment customer facing roles and allow for further penetration of brand messaging, while driving innovation. Evaluate and recommend new optimization methods to improve customer experience. Generate innovative ideas to increase web traffic and ensure best web practices are being met, and brand strategies and identities are maximized. Understand the long-term impact based on market dynamics now and in the future and facilitate strategy and plan implementation to produce long term profitable access, while meeting short term key brand performance metrics.
Work with IT and external vendor partners to manage user experience across platforms, assisting with problem resolution. Partner with brand teams, key sales, operations and market access personnel, as well as other internal stakeholders to ensure digital, financial and strategic optimization. Ensure customer 360 lens is clearly understood by brand leadership, is incorporated into analytics, is compliant and validated. Evaluate and recommend new optimization methods to improve customer experience. Act as a champion and change agent in leading the organizational changes required to create and sustain digital capabilities. Foster productive relationships with key senior customer decision makers.
Manage the day-to-day operations of Marketing and Omni-Channel Strategy, including all budget-related, project management oversight and other issues. Oversee the print channel to ensure effective dissemination of all communication and tools meet the internal customer expectations. Work with IT to manage user experience across platforms, assisting with problem resolution. Act as a champion and change agent in leading the organizational changes required to create and sustain digital capabilities.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education (from an accredited college or university):
Bachelor's Degree required; degree in Marketing, Business Administration, or other related area preferred
MBA Marketing, Business Administration, or related area preferred
Experience:
10 or More Years overall related experience required
7 or More Years Experience in developing and implementing digital marketing strategies required
4 or More Years Pharmaceuticals Experience including Sales, Marketing, IT or Market Access Leadership or other related area preferred
Travel:
Ability to travel up to 30%
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:
$198,160.00 - $297,240.00
Download Our Benefits Summary PDF
Auto-ApplySenior Associate SP&L
Ridgefield, NJ job
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary:
This is an operational position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of role, and/or complexity. This position has strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.
Has sufficient knowledge to identify critical issues or problems with projects and/or identification of issues which may compromise patient dosing or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized and the need for CAPAs or reports on deviations is clearly understood. Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address such issues or concerns. Experience with IRT systems and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross functional and on Global teams.
Responsibilities:
* Works, under supervision, with outsourcing to submit appropriate requirements on a project basis. Supports team in generating RFPs and in reviewing proposals and selecting vendors. This position also supports the management of the WO development and implementation.
* Supports packaging design and patient kit supply preparation, label generations and approvals and associated interactions with vendors. Supports regular vendor/sponsor discussions to identify risks and ongoing study support. Identifies critical issues which may compromise patient dosing or safety. Supports comparator sourcing requirements, RFP generation and working with outsourcing to submit appropriate requirements on a Project basis.
* Vendor Management - support interactions with Vendors on packaging design and patient kit supply preparation, label generations and approvals. Support regular vendor/sponsor discussions to identify risks and ongoing study support.
* Ensures on time site shipments for subject and patient dosing, and ensures that material is fully released prior to shipment to site
* Ensures compliance with all domestic and foreign regulatory requirements but may seek line management support when necessary. Basic knowledge of Import/export requirements to the extent that there is overall recognition of potential global issues as regards import license requirements, shipment delays and is able to communicate the issues and support resolution development.
* Support IRT design for control of drug dispensing and inventory management. Understand User specifications in support of IRT processes and basic concepts of IRT
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)
* Bachelor's Degree required
* Master's Degree preferred
Experience Qualifications
* 4 or More Years related professional experience required.
* Must have professional experience Project Management, Clinical Supply Management, and/or Clinical Trials Coordination
* Demonstrated experience in working in any of these areas: inventory management, forecasting, and distribution of drug supply needs, IXRS experience, managing vendors and contributing to budget control 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:
$99,120.00 - $148,680.00
Download Our Benefits Summary PDF
Associate Senior Counsel, Privacy
Eisai job in Nutley, NJ
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Associate Senior Counsel, Privacy, is a strategic, business-minded, and hands-on attorney role whose job will be to lead Eisai's privacy initiatives across the U.S. and Canada and partner with cross-functional teams to design and implement practical privacy solutions that enable the Company's innovation while protecting data and mitigating risk. The role requires deep expertise in privacy law, strong communication and interpersonal skills, and the ability to provide timely, practical guidance while driving rapid results. The ideal candidate is a proactive, collaborative and adaptable professional who is comfortable working in a fast-paced environment, able to balance legal risk with business needs, communicate complex issues in relatable terms, and embed privacy into Eisai's business strategies.
In expanding and managing Eisai's U.S. Privacy Program, the responsibilities of the Associate Senior Counsel, Privacy, include, but are not limited to, practical and timely counseling on privacy issues involving personal data (e.g., PII, PHI, consumer health information), partnering with business groups to identify and execute privacy solutions for priority initiatives and daily business activities, developing and updating privacy policies and procedures, conducting privacy risk assessments and privacy-related investigations and implementing any resulting mitigation and/or remediation plans, supporting cross-functional teams on information governance, partnering with Legal and other cross-functional colleagues to provide guidance and support on Artificial Intelligence (AI) initiatives and governance, and conducting company-wide privacy training and awareness initiatives.
The Associate Senior Counsel will also be expected to support the HR team on employee benefits issues, including counseling on privacy issues arising from benefits administration, negotiation of vendor agreements, and development and implementation of a governance framework.
Responsibilities
Privacy (80%)
· Counsel and support business teams across the organization (Sales, Marketing, Medical, Market Access, Corporate Advocacy, HR, IT, Data Governance, Government Affairs, R&D, etc.) in executing both high-priority strategic initiatives (e.g., data-driven platforms, AI, digital patient and HCP-facing projects, omnichannel activities, targeted advertising, etc.) and daily business activities in compliance with state, federal and global privacy laws.
· Draft, review, update and negotiate privacy-related agreements, consents, disclosures, and notices.
· Support development and implementation of privacy policies and guidelines, including AI governance, data use protocols and digital playbooks.
· Conduct privacy risk assessments (e.g., website cookie audits, state-required risk assessments for initiatives involving Personal Information) and develop, execute, and manage the creation and completion of mitigation and remediation plans.
· Lead or support internal investigations and assessments related to data privacy and security.
· Counsel on privacy-related issues arising from commercial and medical review committee submissions.
· Advise on cross-border data transfers (e.g., clinical data) and collaborate with global privacy counterparts to ensure compliance with international frameworks (e.g., GDPR, PIPEDA) and alignment on enterprise-wide privacy initiatives.
· Participate in and/or support internal governance committees (e.g., regional AI Committee) to provide legal input on privacy and data ethics.
· Manage consumer requests for personal data inquiries per applicable regulations (e.g., CCPA)
· Deliver privacy training and awareness programs across the organization (e.g., Privacy Day/Week).
· Monitor regulatory developments and assess their impact on business operations.
· Collaborate with Government Affairs colleagues to proactively address public policy matters involving privacy.
Benefits (20%)
· Counsel and support the HR team on HIPAA compliance and broader regulatory obligations (including ERISA, COBRA, and ACA) as they intersect with privacy and data handling in the administration of the Company's benefits programs.
· Provide legal guidance on employee data privacy in the context of benefits administration (e.g., wellness programs, third-party platforms).
· Coordinate with HR and IT to ensure secure handling of PHI in benefits programs.
· Draft, review, update and negotiate benefit vendor agreements.
· Support development and implementation of governance framework for benefits programs.
Requirements
· J.D. from an accredited law school and admission to practice law in any U.S. jurisdiction (as evidenced by a Certificate of Good Standing).**
· 7+ years as a practicing, licensed attorney with high-level client contact and responsibility, with 4-6 of those years focused on privacy counseling (preferably in the pharmaceutical/biotech industry).
· Deep knowledge and experience advising on applicable state, federal and international privacy laws.
· Experience advising on privacy issues relating to digital health initiatives, online advertising and cookie compliance.
· Demonstrated ability to act independently with urgency, work in a fast-paced environment, juggle multiple high-priority items, manage client expectations, and timely deliver strategic advice.
· Demonstrated curiosity and adaptability, with a willingness to take on new and unfamiliar topics, learn quickly, and step outside of one's comfort zone to deliver results.
· Strong problem-solving and analytical skills - demonstrates expert understanding and analysis of the issues and exercises creativity and initiative when offering solutions.
· Strong interpersonal skills with the ability to build relationships across teams; enjoys collaboration and thrives in a role that requires frequent live interaction and engagement with stakeholders.
· Team player who can work cross-functionally in a complex organizational structure and deepen their business acumen.
· Strong written and verbal communications skills - able to clearly communicate with client groups at all levels of the company in a way that makes privacy relatable and tailors the message to the audience, whether in daily counseling or in delivering presentations.
· Strong drafting and negotiation skills.
· Strong project management skills such as scheduling, planning, and prioritizing a variety of activities, initiatives, and projects from different individuals, groups, or departments.
· Individual will partner with and receive strategic guidance from manager, but must be comfortable managing priorities and taking ownership of end-to-end execution as a team of one.
· Proficient technology skills.
· Work in-person at the Company's New Jersey office Tuesday through Thursday every week.
** If not licensed to practice law in New Jersey, selected candidate must obtain a limited law license pursuant to New Jersey Court Rule 1:27-2.
Skills:Business Acumen, Communication & Cross-functional Influence, Critical Thinking & Business Agility, Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management, Legal Knowledge, Mentoring/ People Development, Stakeholder Management (Legal/ Compliance)
Eisai Salary Transparency Language:
The annual base salary range for the Associate Senior Counsel, Privacy is from :$189,100-$248,200Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplySenior Manager, Medical Information, Oncology
Eisai job in Nutley, NJ
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
The Senior Medical Information Manager is responsible for contributing to the development and implementation of the Medical Information component of the strategic plan for their assigned therapeutic area. In addition, the Senior Medical Information Manager leads cross functional teams and initiatives to support Medical Affairs and business objectives.
Responsibilities:
• Respond to unsolicited medical inquiries from healthcare professionals, patients/consumers, field staff and other internal business partners.
• Develop and manage tactical execution of the Medical Information plan for their assigned therapeutic area.
• Utilize scientific expertise to lead the development and maintenance of medical information resources for assigned products to meet the needs of external customers and internal business partners.
• Conduct detailed analyses of scientific literature to communicate relevant scientific information and competitive issues with Medical Affairs colleagues, cross-functionally and globally.
• Implement Medical Information component of strategic medical plans for assigned products, including implementing performance improvement activities, service quality monitoring, and tracking and reporting of metrics.
• Serve as POC for medical and scientific review of promotional and scientific exchange materials in CRC and MRC in collaboration and partnership with Medical Directors.
• Provide inputs to the overall development of budget and resources and escalate deviations, as needed.
• Analyze metrics and develop insights reports on Medical Information activities presented to internal stakeholders.
• Provide scientific support for assigned stakeholders on ad hoc projects and/or initiatives, including at Medical Information Booths for assigned medical conferences.
• Provide supervisory guidance, training to new hires/ less experienced colleagues and/or mentorship to pharmacy students.
Qualifications:
• Advanced degree in sciences or related field with 8+ years of experience in the pharma/ biotech industry.
• OR a combination of equivalent education and experience.
• Advanced knowledge of U.S. regulatory standards related to pharmaceutical manufacturers' communications and dissemination of medical information.
• Knowledge of clinical trials, drug approval processes, and clinical application of drug products.
• Prior experience in medical writing and development of scientific communication materials.
• Some experience coaching and mentoring new hires/ less experienced colleagues.
• Proficiency with Microsoft Office Suite software, Sharepoint, Veeva, customer relationship management software and other technology and telephony systems.
• Proven performance in earlier role.
• Hybrid, onsite in Nutley NJ, 3 days a week (Tuesday, Wednesday and Thursday)
Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review, Mentoring/ People Development, Resource Planning & Management
Eisai Salary Transparency Language:
The annual base salary range for the Senior Manager, Medical Information, Oncology is from :$130,500-$171,300Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyExecutive Director, Global Regulatory Affairs - Neurology
Eisai job in Nutley, NJ
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Job Summary
The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory/business objectives.
The Executive Director will direct the development and submission of investigational drug applications, product registration dossiers, supplements, amendments, as well as providing strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedite approval of pending registration and answers any questions. This includes oversight, guidance, and management of GRS teams responsible for large, late stage development program or for multiple early stage development programs. Using a hands on approach, this position will ensure the completion of all goals and objectives of the Business Group for these programs as related to regulatory submissions and milestones including interactions with Health Authorities. This role requires experience with NDA/BLA, MAA and supplementary applications.
Essential Functions
· Provide global regulatory leadership in support of the global development, registration, and life-cycle management of products under responsibility.
· Ensure the efficient, timely and compliant execution of regulatory strategies and programs.
· Directs and manages a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development, as well as life cycle management of existing products.
· May serve as the lead regulatory representative on the project team throughout the product lifecycle.
· Provide senior staff advice and guidance on regulatory issues, especially for US.
· Responsible for oversight and strategic planning of the meetings with FDA, EMA, PMDA. Provide strategic support for meetings with other Health Authorities the CDE.
· Actively participates in Health Authority GCP inspections (e.g., FDA, EMA, PMDA) including responding to observations and development of corrective actions.
· Keep abreast of changes in the regulatory environment and implement necessary adaptations.
· Provide expert opinion, advice and strategic direction on emerging policy & intelligence matters.
· Ensure continued engagement, development and performance management of staff.
· Determining timelines and budgets for program activities and report accordingly.
· Lead and participate in global regulatory initiatives and committees.
Qualifications
· Bachelor's degree and at least 12 years industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.
· Education area of study in a scientific discipline with a Master's or other advanced degree preferred.
· Position involves line management responsibility for personnel in US and UK and has both direct and indirect reports. Demonstrated success in leading and managing teams is required.
· Experience in the successful prosecution of NDA/BLA, MAA and supplementary applications in essential.
· Demonstrated track record of interfacing effectively with FDA, EMA and other global regulatory agencies.
· Experience in managing the preparation of a marketing application (NDA/BLA/MAA) in CTD format for a major market (US, EU, Canada).
· Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
· Excellent operational skills including planning, organizing and ability to motivate and lead others.
· Excellent verbal and written communication skills and comfortable presenting to all levels of an organization including its Senior Management.
· Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while maintaining composure an acting with integrity and credibility to build trust.
· Ability to effectively work with a variety of personnel across a matrix organization and work collaboratively with cross functional teams.
· Sense of urgency and perseverance to achieve results.
. Position may be remote or hybrid.
#LI-CC
Bachelor's degree (Master's preferred) and 10+ years of relevant experience. Experience in Life Sciences industry preferred.Skills:
Eisai Salary Transparency Language:
The annual base salary range for the Executive Director, Global Regulatory Affairs - Neurology is from :$272,200-$357,300Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-Apply