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Every career with Hearst Television is like a story. How it develops, where it takes you, the milestones you reach along the way – you’ve got a lot to look forward to as your unique career story unfolds. Hearst Television, a subsidiary of Hearst, owns and operates local television and radio stations serving nearly three dozen U.S. cities, reaching 24 million U.S. television households. Through its partnership with nearly all major networks, Hearst Television distributes national content across more than 120 video channels, including programming from ABC, NBC, CBS, CW, MY Net, MeTV, This TV, Estrella, and more. Hearst Television is recognized as one of the industry's premier companies. It has been honored with numerous awards for distinguished journalism and industry innovation, including the Walter Cronkite Award for political journalism, the national Edward R. Murrow Award, the DuPont-Columbia Award, and the George Foster Peabody Award.

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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 Director of Global Submission Management (GSM) is responsible for leading, managing, strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This role involves providing hands-on operational support for submission activities while ensuring strategic alignment and process optimization across different regions. It also includes resource planning, budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads of Submissions Management for the EU and Japan as needed and utilize \"Follow-the-sun\" processes to ensure submission timelines are met regardless of the region.

The Associate Director, Global Submission Management (GSM, is responsible for the effective operation of Global Submission projects, ensuring the consistent application of global procedures and standards, and proactively assessing process performance for necessary optimizations. The Associate Director serves as the primary liaison between R&D functions, acting as the submission lead for designated global applications (e.g., INDs, NDAs, MAAs, supplements, amendments, and variations), to facilitate cross-functional logistics and communication that support submission planning. This role provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in accordance with agreed-upon submission timelines. Additionally, the AD oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final deliverables, ensuring compliance with applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, HC, PMDA, Emerging Markets, ICH, CDISC) within defined timelines.

Essential Functions:

Leadership and Strategy

Provides leadership for the Global Submissions Team ensuring projects are appropriately resourced, partnering with other regional Submission Heads for additional support for resources when needed.
Provides the Regulatory Submission Management for a lead compound or submission project that has been identified as critical to Eisai's business success.
Provides management oversight for the Global Submission Management department, supporting the generation, and when necessary, the re-engineering of Eisai \"Best Practices\" related to global submission management and dossier development in pursuit of optimal processing performance while maintaining full compliance with Health Authority requirements and guideline.

Global Collaboration

Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement \"follow-the-sun\" workflows for timely submissions across all regions.
Foster strong cross-regional communication and collaboration to support global objectives.
Promotes a culture of performance and teamwork, with a focus on staff development in technical skills, interpersonal skills, education, and training, enhancing competency and professionalism.
Maintains visibility within the organization by regularly presenting on various GSM-related topics. This includes showcasing the achievements, ongoing projects, and developments of the GSM organization, as well as emerging trends in eCTD regulatory submissions. Additionally, cultivate positive and constructive relationships with other members of the Global Regulatory Operations (GRO) team and regulatory colleagues.
Actively participates in agency/industry events regularly, staying abreast of current developments, trends, and technologies, fostering constructive business relations with other industry peers, Health Authority representatives, and critical business partners/vendors.
Analyzes trends and evaluates the impact of changes in Health Authority requirements for e-submissions, communicating these changes to the relevant areas within Eisai and driving the necessary changes to processes and procedures.
Ensure the timely completion of all administrative tasks for this position, including but not limited to monthly reports, performance objective setting, performance reviews, and training, for self and staff.

Hands-On Submission Support

Actively participates in submission planning and execution, including document compilation, publishing, and quality checks.
Provide technical oversight and troubleshooting for eCTD submissions and related systems.

Operational Excellence

Ensure consistent application of GSM global procedures and standards.
Proactively monitors and assess process performance, identifying opportunities for continuous improvement.

Requirements

Bachelor's degree in scientific or information technology field; advanced degree preferred
8+ years of pharmaceutical industry regulatory experience
5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required
Proficient with U.S. and EU submission requirements including but not limited to Emerging Markets
Advance experience with the drug development process and eCTD regulatory submission standards
Expert understanding of Project Management concepts and techniques
Ability to apply SOPs regulations pertaining to electronic submissions
Ability to lead cross-functional team,establish effective relationships with team members and work well in a cross functional team environment
Advance experience creating timelines for the development and submission of drug filings to regulatory health authorities
Excellent organizational skills to support multi-task and manage submission timelines in a fast-paced environment with changing priorities
Well-organized with the ability to multi-task and work with minimal supervision
Ability to manage change to support organization's effectiveness by implementing change
Effectively communicates written and verbal communication skills
Demonstrates strong analytical, problem solving and critical thinking skills with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.
Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)

Technical Skills Required

Advance working knowledge of global regulatory submission standards, publishing software, software validation concepts, and regulatory publishing best practices
Proficiency in eCTD publishing tools (e.g., Lorenz docuBridge, Extedo eCTDmanager, or equivalent).
Strong understanding of ICH guidelines, regional regulatory requirements, and data standards (e.g., CDISC).
Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (e.g., Veeva Vault, SharePoint, Documentum)
PowerPoint, SharePoint, XML, Adobe Acrobat, ISI Toolbox and eData transfer systems
Ability to troubleshoot technical issues related to electronic submissions and publishing.

We are open to remote-based, but the preference for this role is a hybrid work arrangement in Nutley, NJ with 3 days a week in office every week (Tuesday, Wednesday. Thursday).

Eisai Salary Transparency Language:

The annual base salary range for the Associate Director, Global Submission Management is from :$159,000-$208,700Under 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 https://careers.eisai.com/us/en/compensation-and-benefits.

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

Required

Preferred

Job Industries

Other

","

At Eisai, satisfying unmet medical needs and increasing the benefits health...","Associate Director, Global Submission Management",["B","2513148872"],"2 months ago","/jobs/2513148872-associate-director-global-submission-management","/jobs?keyword=Associate+Director%2C+Global+Submission+Management",{"_429":428,"_434":528,"_452":453,"_444":445,"_243":529,"_441":521,"_427":428,"_111":514,"_431":194,"_433":194,"_454":453,"_442":443,"_425":530,"_455":456,"_430":115,"_476":531,"_460":532,"_478":514,"_479":443,"_481":482,"_483":484,"_485":517},["D",1770681600000],"

The Associate Director is responsible for supporting the development of strategies for assigned product(s) and execution of health economics, outcomes research and real-world evidence (HEOR & RWE) research to generate product value data to support Eisai business, including the development of communication tools. This role primarily focuses on late-stage pipeline and marketed products, interfaces with cross-functional teams including marketing, market access, and medical affairs to help develop HEOR strategy, and partners with HEOR field team in the development of external communication materials. The Associate Director facilitates coverage, reimbursement and appropriate utilization based on generation and communication of quality data.

Essential Functions

Support the formulation of HEOR and RWE strategies aligned with the business and patient needs to develop compelling value proposition that drives optimal access and utilization of Eisai marketed products in the United States.
Align health economics and outcomes research strategies, timelines and budgets with medical affairs, marketing, market access and global value and access teams. Projects will be prioritized to achieve effective utilization of resources; strategy will be aligned to the global business needs.
Partner with Field HEOR to develop the payer communication strategies, content and tools of product-specific health economic and outcomes value propositions. Support Eisai's recognition as a credible and forthright contributor to the assessment and optimal use of healthcare resources, and an advocate for patient access to appropriate therapeutic alternatives.
Execute all aspects of HEOR and RWE projects to meet the Eisai needs of key external stakeholders and internal business partners.
Effectively communicate and network to establish and maintain strong relationships with KOLs for HEOR and RWE related collaborations.
Monitor current methodological, clinical practice and professional guidelines, as they relate to health economics and outcomes, for the appropriate and optimal conduct of research and evaluations. Research project results have to be effective in ensuring that decision making will meet the needs of patients, providers and payers as well as optimize access to Eisai's products and appropriate medical care
Travel to national and international meetings and conferences to support the business needs.

Requirements

Doctoral degree (PhD, PharmD, MD) in health services research, public health, epidemiology, statistics, health economics, medicine, pharmacy administration or related field.
A minimum of 5 years' experience in RWE/Outcomes Research/Epidemiological Research/Health Economics either within biopharmaceutical industry and/or provider/payer organizations.
Demonstrated applied research experience in conducting health economic, health related quality of life, and/or health services research studies.
Experience in the design and execution of HEOR and RWE studies, including the writing of protocols and analytic plans for prospective and retrospective studies, analyzing and collecting patient-reported outcomes, claims and EMR databases.
Application of health economic models for product value assessment and comparison.
Strong scientific communication record in terms of the development of tools for field medical teams, conference presentations and manuscripts.
Demonstrated ability to work collaboratively in and lead cross-functional teams.
Development of professional relationships with customers, key opinion leaders and peers.
Strategic and conceptual skills to develop innovative approaches for demonstrating product value and differentiation

Preferred Knowledge

CNS therapeutic areas.
Knowledge of pharmaceutical development and lifecycle management.
Knowledge of regulatory and industry guidelines in the delivery of health care information in promotional and non-promotional settings and dissemination of health outcome studies and economic evaluations.
Background in statistics, epidemiology, and public health.
Pharmaceutical and reimbursement environment, especially as related to neuroscience.
Experience with utilization of outcomes studies in managed care or large healthcare organization environment.

Eisai Salary Transparency Language:

The annual base salary range for the Associate Director, US HEOR & RWE (Remote-Based) is from :$185,600-$243,600Under 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.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Right To Work

E-Verify Participation

Required

Preferred

Job Industries

Other

",["B","2513046351"],"9 days ago","/jobs/2513046351-associate-director-us-heor-rwe-remote-based",{"_429":428,"_434":534,"_452":453,"_444":445,"_243":438,"_441":438,"_427":428,"_111":437,"_431":432,"_433":194,"_454":453,"_442":535,"_425":536,"_455":456,"_430":115,"_476":477,"_460":537,"_478":437,"_479":535,"_481":482,"_483":538,"_485":486},["D",1771200000000],"None, None, US",["B","2619521978"],"/jobs/2619521978-compliance-business-partner-associate-director","/jobs?location=None%2C+None%2C+US",{"_429":428,"_434":540,"_452":453,"_444":445,"_243":541,"_441":521,"_427":428,"_111":542,"_431":194,"_433":194,"_454":453,"_442":443,"_425":543,"_455":456,"_430":118,"_476":524,"_460":544,"_478":542,"_479":443,"_481":482,"_483":484,"_485":545},["D",1764028800000],"

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.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Right To Work

E-Verify Participation

Required

Preferred

Job Industries

Other

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