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Overview Conducts comprehensive assessment of member UAS-NY for potential new members and existing members' conditions clinical, environmental, and social to establish an individual plan of care needed to maintain the member safe in the community. Identifies solutions that promote high quality and cost-effective health care services. Manages requests for services from providers, members, and care management team and renders clinical determinations in accordance with VNS Health Plans policies as well as applicable state and federal regulations. Works under general supervision. • Conduct face-to-face or telehealth UAS-NY assessments according to state guidelines, policies, procedures, and protocols, • Utilize clinical skills to assess and document all aspects of the potential members long-term community-based needs, • Communicate with members, families, providers, and other parties as needed to complete an accurate comprehensive assessment, • Utilizes VNS Health and state-approved assessment questionnaire, guidelines, and documentation as well as interviews with members, family, and care providers in decision-making, • Performs in-home assessment for members who have identified significant changes in condition since last in-home assessment; provides comprehensive review and determination of member’s needs, including completion of UAS assessment questionnaire, tasking tool, and a projected service plan. Visits include all areas serviced by VNS Health Plans including upstate and downstate counties, • Performs in-home assessment on members to determine the appropriate service plan, including completion of UAS assessment questionnaire, tasking tool, and a projected service plan. Visits include all areas serviced by VNS Health Plans, • Explains VNS Health Plan benefits, including an explanation of the member's handbook, • Ensures compliance with state and federal regulatory standards and VNS Health Plans policies and procedures, • Identifies opportunities for alternative care options and contributes to the development of a safe member centered service plan, • Consult with supervisor and others in overcoming barriers in meeting goals and objectives, • Maintains current knowledge of organizational or state-wide trends that affect member eligibility, • Coordinates with other departments, e.g. Care Management, Legal Affairs, Grievance and Appeals, Compliance, Membership Eligibility Unit, Quality as needed, • Participates in requests for out-of-network services when a member receives services outside of VNS Health Plans network services, • Keeps current with all health plan changes and updates through on-going training, coaching and educational materials, • Participates in special projects and performs other duties as assigned Qualifications Licenses and Certifications: Current license to practice as a Registered Professional Nurse in New York State required. Certified Case Manager preferred. Education: Bachelor's Degree in nursing or equivalent work experience required. Master's Degree in nursing or equivalent work experience preferred. Work Experience: Minimum two years of clinical assessment, homecare or hospital experience required. Excellent organizational and time management skills, interpersonal skills, verbal and written communication skills required. Demonstrated strong relationship management skills, including a high degree of psychological sophistication and non-aggressive assertiveness required. Demonstrated successful conflict management skills and negotiation of “win-win” solutions required. Working knowledge of Microsoft Excel, Power-Point, and Word required. Knowledge of Medicaid and/or Medicare regulations required. Working Knowledge of UAS-NY preferred. Pay Range USD $85,000.00 - USD $106,300.00 /Yr. About Us VNS Health is one of the nation’s largest nonprofit home and community-based health care organizations. Innovating in health care for more than 130 years, our commitment to health and well-being is what drives us — we help people live, age and heal where they feel most comfortable, in their own homes, connected to their family and community. On any given day, more than 10,000 VNS Health team members deliver compassionate care, unparalleled expertise and 24/7 solutions and resources to the more than 43,000 “neighbors” who look to us for care. Powered and informed by data analytics that are unmatched in the home and community-health industry, VNS Health offers a full range of health care services, solutions and health plans designed to simplify the health care experience and meet the diverse and complex needs of the communities and people we serve in New York and beyond.

Overview Conducts comprehensive assessment of member UAS-NY for potential new members and existing members' conditions clinical, environmental, and social to establish an individual plan of care needed to maintain the member safe in the community. Identifies solutions that promote high quality and cost-effective health care services. Manages requests for services from providers, members, and care management team and renders clinical determinations in accordance with VNS Health Plans policies as well as applicable state and federal regulations. Works under general supervision. What We Provide • Referral bonus opportunities, • Generous paid time off (PTO), starting at 30 days of paid time off and 9 company holidays, • Health insurance plan for you and your loved ones, Medical, Dental, Vision, Life and Disability, • Employer-matched retirement saving funds, • Personal and financial wellness programs, • Pre-tax flexible spending accounts (FSAs) for healthcare and dependent care, • Generous tuition reimbursement for qualifying degrees, • Opportunities for professional growth and career advancement, • Conduct face-to-face or telehealth UAS-NY assessments according to state guidelines, policies, procedures, and protocols., • Utilize clinical skills to assess and document all aspects of the potential members long-term community-based needs., • Communicate with members, families, providers, and other parties as needed to complete an accurate comprehensive assessment., • Utilizes VNS Health and state-approved assessment questionnaire, guidelines, and documentation as well as interviews with members, family, and care providers in decision-making., • Performs in-home assessment for members who have identified significant changes in condition since last in-home assessment; provides comprehensive review and determination of member’s needs, including completion of UAS assessment questionnaire, tasking tool, and a projected service plan. Visits include all areas serviced by VNS Health Plans including upstate and downstate counties., • Performs in-home assessment on members to determine the appropriate service plan, including completion of UAS assessment questionnaire, tasking tool, and a projected service plan. Visits include all areas serviced by VNS Health Plans., • Explains VNS Health Plan benefits, including an explanation of the member's handbook., • Ensures compliance with state and federal regulatory standards and VNS Health Plans policies and procedures., • Identifies opportunities for alternative care options and contributes to the development of a safe member centered service plan, • Consult with supervisor and others in overcoming barriers in meeting goals and objectives., • Maintains current knowledge of organizational or state-wide trends that affect member eligibility., • Coordinates with other departments, e.g. Care Management, Legal Affairs, Grievance and Appeals, Compliance, Membership Eligibility Unit, Quality as needed., • Participates in requests for out-of-network services when a member receives services outside of VNS Health Plans network services., • Keeps current with all health plan changes and updates through on-going training, coaching and educational materials., • Participates in special projects and performs other duties as assigned. Qualifications Licenses and Certifications: Current license to practice as a Registered Professional Nurse in New York State requiredCertified Case Manager preferred Education: Bachelor's Degree in nursing or equivalent work experience requiredMaster's Degree in nursing or equivalent work experience preferred Work Experience: Minimum two years of clinical assessment, homecare or hospital experience requiredExcellent organizational and time management skills, interpersonal skills, verbal and written communication skills requiredDemonstrated strong relationship management skills, including a high degree of psychological sophistication and non-aggressive assertiveness requiredDemonstrated successful conflict management skills and negotiation of “win-win” solutions requiredWorking knowledge of Microsoft Excel, Power-Point, and Word requiredKnowledge of Medicaid and/or Medicare regulations requiredWorking Knowledge of UAS-NY preferred Pay Range USD $85,000.00 - USD $106,300.00 /Yr. About Us VNS Health is one of the nation’s largest nonprofit home and community-based health care organizations. Innovating in health care for more than 130 years, our commitment to health and well-being is what drives us — we help people live, age and heal where they feel most comfortable, in their own homes, connected to their family and community. On any given day, more than 10,000 VNS Health team members deliver compassionate care, unparalleled expertise and 24/7 solutions and resources to the more than 43,000 “neighbors” who look to us for care. Powered and informed by data analytics that are unmatched in the home and community-health industry, VNS Health offers a full range of health care services, solutions and health plans designed to simplify the health care experience and meet the diverse and complex needs of the communities and people we serve in New York and beyond.

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit ___ for more information. The Leukemia & Transplant Senior Oncology Account Manager is responsible for direct promotion of Jazz Pharmaceuticals’ products, and the development and management of business relationships with therapeutic specialists within an assigned geographical territory. The Senior Oncology Account Manager (OAM) is an integral part of the commercial team that includes all personnel dedicated to the sales and marketing functions. The Senior Oncology Account Manager will implement Jazz Pharmaceuticals’ marketing strategies and marketing tactics to achieve sales goals through short-term and long-term objectives. This position reports directly to the Regional Sales Manager and covers New York City and Long Island, NY. Key Skills: Strategic Account Management: * Customer Understanding * Possess strong sales analytics capabilities with demonstrated understanding of prescribing and purchasing decision processes and any marked differences from national trends * Demonstrate a thorough understanding of: * Internal customer business models - how profit is generated, business and financial risks, cost impacts of managing patient care * External customers - current reimbursement landscape/ managed care, payer issues and trends, and other factors which inform the development of one’s annual territory business plan * Gain understanding of customer needs through thorough research and analysis to understand the specific needs and requirement of each customer/and or account * Identify key stakeholders within the account and understand their roles, priorities, motivations and patient needs * Proven excellence to leverage all available resources - dashboards, alerts, omnichannel reports, speaker programs, conference attendance * Actively gain customer insights and provide timely feedback to cross-functional partners and regional sales manager regarding account business trends, changes in the therapeutic landscape, performance, industry issues and business opportunities and obstacles * Strategic Planning: Keep the needs and expectations of the customer/patients at the forefront of all that we do * Define clear, measurable objectives that align both with the company goals and the goals and needs of the customer * Develop tailored strategies and tactics to address the unique needs and challenges of each customer * Determine the resources required to execute the strategic account plan effectively * Continuously review and adjust the strategic account plan based on activities, feedback, changing market conditions and evolving customer needs * Develop and implement customized account strategic plans with clear next steps, specific strategies and tactics and appropriate utilization of resources while meeting the needs of our customers * Demonstrated collaborative efforts with cross-functional teams including marketing, medical affairs and market access to align and execute on account strategies to achieve common business objectives * Work with customer facing colleagues to facilitate achievement of the respective functional tactical objectives * Recognize changes in the work environment to ensure effective development and implementation of alternate plans to achieve objectives, modify call plan/business plan activities as needed * Strong ability to identify patterns and trends from multi-source data (OmniChannel) for divergent collaborative problem solving Teamwork & Collaboration: * Maintain an enterprise mindset and cross-functional thinking to maximize one Jazz customer engagement * Highly effective at leveraging cross-functional partnerships with marketing, medical affairs and market access with the goal to advance Business Unit and organizational interests * Engage and align with cross-functional partners to mobilize resources and ideas to deliver to successfully meet customer and patient needs * Actively shares insights and best practices across the team; demonstrates trust in others by consistently finding opportunities to contribute to their effectiveness and impact * Work effectively with customer facing colleagues to facilitate achievement of the respective functional teams tactical objectives * Lead where appropriate as the main point of contact for designated accounts and collaborate with cross-functional partners to create a streamlined, organized interface between account stakeholders and all field facing colleagues Selling Effectiveness: * Effective promotion of Jazz Pharmaceuticals Adult Oncology products to physicians and other health care providers within the designated area at both community and Academic centers * Institute a network-selling mindset to customer relationships, seeing them as part of a connected healthcare ecosystem to broaden connections across an account * Stay abreast of industry trends, competitive landscape, and clinical developments in oncology to effectively communicate product differentiation and value proposition * Ability to adapt quickly to new tools and resources for successful customer engagement; leverages analytics to assist with developing insights and next best action plans * Identify, establish and maintain strong relationships with key physicians, health care providers and organizations within assigned territory Product and Scientific Knowledge: * Educate physicians and other health care professionals about Jazz Pharmaceuticals product(s), providing the most current information about the approved indications for the company’s products within the current disease areas of focus: pediatric and young adult acute lymphoblastic leukemia (ALL) and bone marrow transplant * Demonstrates a superior level of effectiveness in communicating, educating, and consulting across multiple disease states * Effectively and appropriately responds to the customer’s questions about other approved products/therapies, based on the clinical information contained in the package insert and per company compliance guidelines * Demonstrate to customers and internal team members a high level of clinical knowledge of a) the disease state, and b) Jazz product(s), based on the clinical information contained in the package insert * Demonstrates confidence in appropriately challenging prescribers about treatment decisions associated with assigned product Execution: * Participate in organizing and facilitating meetings for the exchange of medical and product information in line with the company’s policies, regulatory and legal requirements * Represent company at live and virtual conferences, attend company meetings, educational events, training programs and functions as needed * Utilize CRM tools to effectively manage customer interactions, track sales activities and maintain accurate territory records * Present a positive and professional image of Jazz Pharmaceuticals, and ensure activities are consistent with and enhance the company’s ethical pharmaceutical marketing policies and procedures * Special projects as assigned * Comply with all legal/regulatory guidelines of the Food, Drug and Cosmetic Act, the Prescription Drug Marketing Act, the Pharma Code, OIG guidelines, and all other applicable federal and state regulations * Perform all activities within allocated budget Required Experience * Four-year college/university degree * Experience in Oncology * Excellent verbal and written communication skills with an effective presentation style both in face to face and virtual interactions to connect and build credibility with healthcare professionals * Ability to meet territorial travel requirements Preferred Experience * Post-graduate business school study, training * Minimum of 5 years in the oncology market * Strong clinical, technical and scientific knowledge of product(s); applicable disease states desired * Strategic thinker who can drive a strategic account business plan * Strong key account management experience working in complex academic and community accounts, identifying influential stakeholders, and working with them to better serve patients * Demonstrated history of strong business acumen, problem solving, effective prioritization, account management and effective sales data analytics skills * Skillful in fostering teamwork and collaboration in cross-functional account management * Results oriented with a proactive and Self-motivated approach to driving sales growth * Experience with pediatric and young adult ALL and bone marrow transplant highly preferred * Key Account & Market dynamics knowledge Description of Physical Demands * Frequent travel between meeting sites * Frequently operating a computer, printer, telephone and other similar office machinery * Frequent interactions with external contacts in their office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes * Frequent computer laptop or tablet use, not usually at a workstation * Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands * Frequent public contact requiring appropriate business apparel #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $155,200.00 - $232,800.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: ___.

Role Overview As Privacy Counsel, you will serve as a senior legal advisor on complex privacy, data protection, and cybersecurity matters for a New York City government agency. This role demands a seasoned attorney who can operate independently, advise senior leadership, and drive privacy initiatives across a large, multi-agency environment. Key Responsibilities Legal Advice & Counsel • Provide expert legal advice on complex, sensitive, and urgent privacy, data protection, and cybersecurity matters related to agency priority initiatives, • Advise on federal, state, and local privacy laws and regulations impacting city agencies and citywide initiatives, • Shape, draft, and review privacy-related policies, legislation, and citywide guidance, • Develop policies, guidance materials, templates, presentations, and training documents to support agency compliance with privacy laws and regulations, • Represent agency leadership in national and international privacy organizations, interagency working groups, and senior-level meetings, • Manage relationships and drive intergovernmental affairs with executive offices, legislative bodies, and key government stakeholders on privacy matters, • Prepare legal briefs and provide strategic advice to government officials and city leadership on privacy matters, • Handle special projects and initiatives as assigned by program leadership Mandatory Qualifications • Minimum 12 years of legal experience, including experience in government, intergovernmental affairs, or implementing and supporting an enterprise privacy program, • Admission to the New York State Bar, in good standing, • Active IAPP certification (e.g., CIPP/US, CIPP/E, CIPM, CIPT, or AIGP), • Demonstrated, hands-on experience advising on complex U.S. privacy and data security laws (e.g., GDPR implications for U.S. entities, CCPA/CPRA, HIPAA, state breach notification laws, and relevant federal, state, and local statutes), • Experience drafting, reviewing, and negotiating privacy-related legal documents including MOUs, NDAs, data sharing/processing agreements, and terms of service, • Track record developing organizational privacy policies, compliance materials, internal/external legal guidance, and templates, • Experience conducting or providing legal support for privacy impact assessments, data protection impact assessments, or similar privacy risk analyses, • Demonstrated ability advising on privacy and data security implications of emerging technologies, digital services, or data use initiatives, • Experience supporting implementation or operation of an enterprise-level privacy program, • Ability to monitor, analyze, and advise on privacy-related legislative and regulatory developments, • Proven ability to provide strategic legal counsel to senior leadership and executive-level stakeholders, • Excellent written and verbal communication skills with the ability to convey complex legal and policy concepts to diverse audiences, including non-legal and technical stakeholders, • Demonstrated ability to collaborate effectively within interdisciplinary teams (IT, policy, operations, legal) to develop and implement privacy solutions Preferred Qualifications • Experience working as an attorney within a government agency (federal, state, or local), or providing extensive direct legal counsel to government agency clients, • In-house experience at a large, complex enterprise or highly regulated industry where policy, legal considerations, and operations frequently intersect Job Type: Contract Pay: $70.00 - $85.00 per hour Expected hours: 35 per week Experience:

About the Company: Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company. Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. POSITION SUMMARY Reporting to the Sr. Director of Executive Management & Government Affairs, will serve as a key partner within the Office of the CEO, supporting enterprise-wide strategic initiatives, executive decision-making, and cross-functional execution. This role will act as a force multiplier to the CEO Office by driving structured analysis, managing high-impact projects, coordinating cross-departmental priorities, and supporting public affairs and external advisory engagements. The ideal candidate is highly analytical, detail-oriented, politically astute, and capable of operating in a fast-paced, high-visibility executive environment. KEY ROLES AND RESPONSIBILITIES • Executive Strategy & Decision Support, • Provide structured analytical support to the CEO and Chairman (COB) on high-priority business issues., • Develop executive-level briefing materials, board presentations, and strategic recommendation documents., • Conduct financial, operational, and market analyses to inform leadership decisions., • Track and systematize key corporate KPIs and executive dashboards., • Enterprise Project Management & Cross-Functional Coordination, • Support enterprise-wide strategic initiatives by establishing milestone tracking and governance frameworks., • Facilitate cross-functional alignment across commercial, medical, regulatory, finance, and operations teams., • Identify risks, bottlenecks, interdependencies and escalate issues proactively., • Prepare periodic executive progress reports and performance summaries., • Drive Process optimization efforts to improve organizational efficiency and reduce silos, • Public Affairs & External Advisory Support, • Support management of external advisory firms, consultants, and lobbying partners., • Conduct regulatory and policy research and assist in risk monitoring activities., • Prepare briefing materials for government relations and strategic stakeholder engagements., • Maintain structured documentation and tracking of external engagements and outcomes. Prepare daily/weekly/monthly distribution related reports and analyze to monitor performance, • Strategic & Special Projects, • Support planning and execution of high-impact strategic initiatives and confidential executive projects., • Develop business cases, scenario analyses, and financial models., • Conduct competitive intelligence and industry benchmarking., • Ensure disciplined execution from project initiation through post-implementation review. WORK EXPERIENCE • 1–3 years of professional experience in corporate strategy, consulting, business operations, project management, finance, healthcare, or related fields., • Experience supporting cross-functional initiatives or participating in multi-departmental projects., • Exposure to executive-level reporting or presentation preparation preferred but not required., • Experience in regulated industries (e.g., healthcare and biopharma) is a plus., • Internship or early-career experience in strategy, analytics, or operations roles will be considered., • Bilingual, Korean preferred. QUALIFICATIONS • Strong analytical and problem-solving skills with the ability to structure ambiguous issues., • Proficiency in Microsoft PowerPoint and Excel; ability to build clear, data-driven presentations., • Strong written and verbal communication skills., • High attention to detail and organizational discipline., • Ability to manage multiple tasks and prioritize effectively in a fast-paced environment., • Demonstrated ownership mindset and willingness to learn., • Ability to handle sensitive information with discretion EDUCATION • Bachelor’s Degree required in business or related field CORE COMPETENCIES • Strategic Thinking – Ability to connect operational details to enterprise-level strategy., • Executive Communication – Clear, concise, board-ready communication skills., • Analytical Rigor – Data-driven mindset with strong quantitative capability., • Project Discipline – Structured planning, milestone tracking, and accountability management., • Organizational Influence – Ability to navigate complex stakeholder environments without formal authority., • Discretion & Integrity – High ethical standards and confidentiality in handling sensitive information., • Agility & Ownership – Comfortable operating in ambiguity with strong execution bias. Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. #LI-MDRD

We are seeking a dietitian, nurse or social worker with experience working in a clinical setting, who is ready to transition into a sales position. You must be highly motivated and results-oriented to promote and drive the sales of parenteral nutrition therapies, including Total Parenteral Nutrition (TPN), Intradialytic Parenteral Nutrition (IDPN), Intraperioneal Parenteral Nutrition (IPN). As a Sales Representative, you will be responsible for establishing and nurturing strong relationships with healthcare professionals, hospitals, clinics, and home healthcare providers to increase market share and drive revenue growth. This is an exciting opportunity to join a pharmacy company and make a significant impact in the healthcare industry. No prior sales experience is required. Prior experience in healthcare, working in a clinical setting, is required. $65k plus commission Responsibilities: 1. Develop and implement a strategic sales plan to effectively promote and sell parenteral nutrition therapies in the assigned territory., 2. Identify and target key healthcare professionals, including dietitians, nurses, and pharmacists, to establish relationships and generate leads., 3. Conduct presentations and product demonstrations to healthcare professionals, highlighting the unique features, benefits, and efficacy of IDPN, IPN, and TPN therapies., 4. Educate healthcare professionals about the appropriate indications and usage of parenteral nutrition therapies, while addressing any questions or concerns they may have., 5. Collaborate with cross-functional teams, including marketing, medical affairs, and customer support, to provide comprehensive support and ensure customer satisfaction., 6. Stay updated on industry trends, competitor activities, and regulatory guidelines related to parenteral nutrition therapies, and communicate relevant information to the internal team., 7. Attend conferences, seminars, and trade shows to network with healthcare professionals, gather market intelligence, and promote parenteral nutrition therapies., 8. Analyze sales data, track market trends, and provide regular reports to management on territory performance, customer feedback, and sales forecasts., 9. Utilize CRM software to manage customer relationships, track sales activities, and maintain accurate records of interactions, leads, and opportunities., 10. Collaborate with reimbursement specialists to address reimbursement-related issues and ensure appropriate coverage for parenteral nutrition therapies. Qualifications: 1. Bachelor's degree in a relevant field, such as life sciences, nutrition, pharmacy, or business administration., 2. Clinical background as a dietitian, nurse, or social worker, with a strong understanding of parenteral nutrition therapies, required., 3. Familiar with healthcare reimbursement processes and experience in navigating reimbursement challenges, preferred., 4. Excellent communication and presentation skills, with the ability to effectively convey complex scientific information to diverse audiences., 5. Strong interpersonal skills and the ability to build and maintain relationships with healthcare professionals and key decision-makers., 6. Self-motivated and goal-oriented, with a demonstrated ability to work independently and meet or exceed sales targets., 7. Proficient in using CRM software and other sales tools to manage customer interactions and track sales activities., 8. Willing to travel within the assigned territory [5 boroughts of New York City, Nassau, Suffolk, Westchester] as required, typically up to 50% of the time., 9. Must have a car, a valid driver's license and a clean driving record. If you are a clinician, such as a dietitian, nurse, or pharmacist, passionate about making a difference in patients' lives and interested in transitioning into a sales role, we invite you to join our dynamic team as a Sales Representative. This is a unique opportunity to contribute to the growth and success of our start-up sterile compounding pharmacy and become an integral part of our mission to provide high-quality parenteral nutrition therapies. Apply today and embark on a rewarding career in healthcare sales.

Physician Affiliate Group of New York (PAGNY) and the Office of Medical and Professional Affairs at NYC Health + Hospitals/Kings County is seeking an Associate Director, Patient Safety and Risk Management. Located in the heart of Brooklyn, Kings County Hospital accommodates more than 518,076 outpatient visits, more than 141,328 emergency room visits, 627 beds, and more than 25,000 inpatient admissions annually. The hospital maintains a strong academic affiliation with SUNY Downstate Health Sciences University to maintain its high standards of healthcare delivery. The Mission of NYC Health + Hospitals is to extend equally to all New Yorkers, regardless of the ability to pay, comprehensive health services of the highest quality in an atmosphere of humane care, dignity, and respect. Their Values are built on a foundation of social and racial equity and have established the ICARE standards for all staff. NYC Health + Hospitals is the nation’s largest municipal healthcare delivery system in the United States. Dedicated to providing the highest quality health care services to all New Yorkers with compassion, dignity and respect, regardless of immigration status or ability to pay. Opportunity Details: • Senior level leadership position., • Manage the provision of patient care to an ethnically and socially diverse patient base., • Support the CMO in ensuring that standards, protocols, leadership, and direction exist to provide the highest quality of care possible to patients., • Assess and upgrade existing medical care standards., • Provide management, leadership, and coaching to all medical staff., • Work with operating and executive team members to implement new operating processes and systems., • Serve as executive sponsor to Root Cause Analysis (RCA) activities and execution of Corrective Action Plans (CAPs) and Risk Reduction Strategies (RRS)., • Oversee Hospital Ethics., • Direct oversight of the Hospital Peer Review Committee. Qualifications: • Board Certification in a medical specialty., • Physician (MD or DO) with an active New York State Medical License., • At least 5 – 10 years of experience providing medical direction and supervision to teams of medical staff., • Must have experience developing and implementing standards of care, medical protocols, quality assurance standards and monitoring, and professional training and education., • Must have experience implementing new clinic operating processes and systems aimed at improving efficiency., • Strong leadership and change management skills., • Understanding of regulatory and accreditation requirements, including but not limited to DOH, CMS, TJC, etc., • Understanding of legal issues, medical malpractice, and patient safety issues related to the delivery of healthcare., • Working knowledge of current hospital policies and procedures., • Ability to identify areas that require further research based upon organizational trends and activities., • Ability to nurture an environment that encourages teamwork and collaboration, both internally and externally. Wages and Benefits include: Annual Base Salary: $325,000* based on a 40-hour work week. The annual total value of compensation package is estimated at $357,500**, which includes the baseline salary, 401(k) contribution, and other factors as set forth below: • 401(k) Company Contribution (subject to IRS contribution limits):, • Employees are immediately vested in a 3% company contribution of base earnings. No employee match is required., • After one year of service, employees receive an additional 7% company contribution of base earnings. No employee match is required., • Annual Continuing Medical Education (CME) Reimbursement., • Generous Annual Paid Time Off (PTO): Vacation, Sick, Holiday, and CME days., • Medical, Prescription, and Dental Coverage: Top-tier plans with employee contributions significantly below market rates., • Life Insurance and Accidental Death and Dismemberment (AD&D) Coverage: Equal to 2x your salary (up to a maximum of $300,000) provided at no cost to you., • Additional employee-paid Voluntary Life and AD&D coverage is available for you and your family., • Medical Malpractice Coverage (equivalent to occurrence-based): Provided at no cost to the employee., • Healthcare and Dependent Care Flexible Spending Accounts (FSAs)., • Pre-tax employee-paid contributions for commuting expenses. Physician Affiliate Group of New York, P.C. (PAGNY) mission is to provide accountable, responsive, quality care with the highest degree of sensitivity to the needs of the diverse population that lives in our New York community. PAGNY is one of the largest physician groups in the country and directly employs nearly 4,000 physicians and allied health professionals who provide services to NYC Health + Hospitals, the largest municipal health care system in the nation serving more than a million New Yorkers annually. Our providers are highly skilled professionals with outstanding credentials who deliver the highest level of quality healthcare to patients throughout New York City. Physician Affiliate Group of New York, P.C. (PAGNY) is an equal opportunity employer committed to equitable hiring practices and a supportive workplace. All candidates are considered based on their individual qualifications, potential, and experience. To learn more about our culture and ongoing workplace practices, please visit our Workplace Culture | PAGNY page. *Salary Disclosure Information: The salary listed for this position complies with New York City's Salary Transparency Law for Job Advertisements. The salary applies specifically to the position being advertised and does not include potential bonuses, incentive compensation, or benefits. Actual total compensation may vary based on factors such as experience, skills, qualifications, historical performance, and other relevant criteria. **The annual total value of the compensation package shown is provided as an illustration and is not guaranteed.

Judi Health is an enterprise health technology company providing a comprehensive suite of solutions for employers and health plans, including: • Capital Rx, a public benefit corporation delivering full-service pharmacy benefit management (PBM) solutions to self-insured employers,, • Judi Health, which offers full-service health benefit management solutions to employers, TPAs, and health plans, and Position Description: Judi Health is looking for a dynamic and experienced regulatory attorney, reporting directly to the General Counsel, to provide strategic legal advice to internal business partners with respect to healthcare regulations and laws. The successful candidate will identify legal and business risks and solutions that balance legal risks and business objectives. You will be expected to develop a keen understanding of the business and operational goals of the enterprise and you will be expected to develop and maintain positive relationships with clients at all levels of the organization, and provide practical and sound advice on legal issues related to business objectives and take an active role in driving projects to a result. Position Responsibilities: Regulatory Affairs & Change Management: • Manage and provide legal oversight for regulatory change management for the Company, including but not limited to monitoring, analyzing, and interpreting federal and state healthcare legislation, proposed legislation, and sub-regulatory guidance., • Track regulatory developments and assess their impact on organizational strategy, operations, and provider relationships., • Provide practical, riskbased legal advice to support regulatory change management initiatives, including implementation planning and crossfunctional execution., • Develop and deliver clear legal guidance, summaries, and recommendations for senior leadership and business stakeholders., • Manage and provide legal oversight for organizational licensing activities, including initial applications, renewals, and compliance with state and federal requirements., • Advise on licensing strategies related to provider expansion, new service lines, geographic growth, and organizational restructuring., • Serve as a legal resource for licensing issues, audits, investigations, and correspondence with regulatory agencies., • Provide legal support for provider relations contracting, including drafting, reviewing, and negotiating provider agreements and related amendments., • Advise on regulatory compliance matters affecting provider contracts, reimbursement arrangements, and network participation., • Collaborate with provider relations, contracting, and compliance teams to ensure contracts align with regulatory, operational, and business objectives., • Partner with compliance, government affairs, operations, and business teams to proactively identify and mitigate legal and regulatory risks., • Support other legal and regulatory initiatives as needed, including audits, investigations, and special projects., • Maintain strong relationships with internal stakeholders and external counsel as appropriate., • 8+ years legal attorney experience in a law firm and/or in-house setting., • In depth knowledge of healthcare laws, regulations and industry standards governing the provision of healthcare., • Juris Doctorate Degree (JD) and admission to the bar in at least one state and in good standing of applicable bar association., • Healthcare laws and regulations including: HIPAA, Medicare, Medicaid, False Claims Act, or Federal Anti-Kickback Statute., • Excellent written and oral communication skills in a professional manner., • Experience working with PBMs and related laws., • Proven ability to thrive in a fast-paced, performance-driven culture., • Demonstrated leadership initiative, resilience and ability to embrace change. Judi Health values a diverse workplace and celebrates the diversity that each employee brings to the table. We are proud to provide equal employment opportunities to all employees and applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, medical condition, genetic information, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. By submitting an application, you agree to the retention of your personal data for consideration for a future position at Judi Health. More details about Judi Health's privacy practices can be found at___.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Program Lead, Digital Informatics QMS Strategy. This Program Lead is responsible for developing, maintaining, and communicating QuidelOrtho' s Quality Management System strategy for Digital Informatics, Software as a Medical Device (SaMD), Artificial Intelligence (AI/ML), and Automation platforms as they pertain to in vitro diagnostic (IVD) products and associated services across all global markets. This role serves as the strategic quality authority for digitalenabled products, ensuring that regulatory, quality, and compliance expectations are proactively embedded into product lifecycle processes, digital delivery models, and organizational ways of working. This position will be onsite in Rochester, NY. * Define and evolve the global QMS strategy for digital health technologies, including SaMD, AI/MLenabled systems, cloudbased platforms, and automated workflows. * Interpret and operationalize global regulatory and standards requirements (e.g., FDA, EU MDR/IVDR, ISO 13485, IEC 62304, ISO 62366, ISO 14971, GxP data integrity) as they apply to digital and informatics solutions. * Partner with R&D, IT, Product Management, Regulatory Affairs, PMO, and Technical Quality to ensure quality by design is embedded throughout the digital product lifecycle. * Establish governance models, procedural frameworks, and decision pathways that enable agile and scalable digital innovation while maintaining regulatory compliance. * Lead riskbased approaches for software lifecycle management, cybersecurity, data governance, AI/ML change control, and algorithm performance monitoring. * Serve as a thought leader and internal consultant on emerging regulatory expectations related to AI/ML, realworld data, automation, and digital transformation. * Perform other work-related duties as assigned. Required: * Bachelors and/or technical degree in Life Sciences, Pharmacy, Engineering, Computer Science, Biomedical Engineering or a related technical discipline. * 8-10 years of progressively responsible experience within a regulated Quality Management System environment, with significant exposure to software, digital health, or informatics solutions. * Demonstrated ability to lead QMS strategy development and influence senior stakeholders across complex, matrixed organizations. * Strong understanding of global regulatory frameworks applicable to digital health, SaMD, AI/ML, and automated systems. * Proven experience applying risk management, design controls, software lifecycle processes, and post market surveillance to digital products. * Ability to translate regulatory and quality requirements into practical, scalable processes that support innovation. * Bias toward action, with a track record of driving execution aligned to organizational strategy. * Excellent written and verbal communication skills, including the ability to represent quality positions to executive leadership. * Strong collaboration skills and the ability to operate effectively across technical, regulatory, and business functions. * Willingness and ability to travel approximately 10-15%. Preferred: * Advanced degree (MS, PhD, or PharmD) strongly preferred. * Experience with AI/ML governance, algorithm change management, or real-world performance monitoring. * Background in cloudbased systems, cybersecurity, data integrity, or regulated automation platforms. * Experience supporting global regulatory inspections involving software or digital health products. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. No strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $155,000 to $202,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

VP / Director, Legal Affairs – Private Credit / Investment Firm A global private credit firm is seeking a VP or Director of Legal to join its growing legal team. This role will be the first legal hire on the team and will serve as a senior legal partner to the investment team and leadership, advising on fund formation, investment structuring, transactions, and regulatory matters across the firm’s private credit platform. All in comp will range from $300K-525K, depending on experience and seniority. This is an opportunity to join a highly entrepreneurial investment platform and play a key role in supporting strategic growth initiatives, including new funds, transactions, and corporate initiatives. There's a clear path to leadership and plenty of runway to define the role, participate in business decisions and shape the culture. Responsibilities • Lead and manage legal aspects of fundraising and fund formation, including structuring investment vehicles, supporting capital raising processes, and coordinating related diligence., • Act as lead counsel on investment structure agreements, partnering closely with internal stakeholders and external advisors., • Support the firm’s strategic growth and M&A initiatives, providing legal guidance across all phases of transactions., • Draft and negotiate a wide range of commercial and transactional agreements related to investment activity and firm operations., • Serve as a trusted legal advisor to investment professionals and leadership on matters impacting the business., • Manage and oversee external counsel relationships in connection with fund and transaction matters., • Assist with regulatory and compliance initiatives, including policies related to securities law, AML/KYC, conflicts, and governance. Qualifications • 7+ years of legal experience in private practice and/or in-house, ideally with experience working on a small team, • Significant experience with fund formation required, ideally with additional experience in private equity, private credit, or debt investment structures, • Strong transactional experience and the ability to partner effectively with investment professionals and senior leadership. Additional Attributes • Exceptional written and verbal communication skills., • Strong business judgment and analytical ability., • High level of professionalism, discretion, and integrity., • Ability to manage multiple workstreams in a fast-paced environment., • Collaborative, proactive, and solutions-oriented mindset. Note: this role is 5 days a week in-office in NYC. Remote candidates will not be considered.

Physician Affiliate Group of New York (PAGNY) and the Office of Medical and Professional Affairs at NYC Health + Hospitals/Kings County is seeking an Associate Director, Patient Safety and Risk Management. Located in the heart of Brooklyn, Kings County Hospital accommodates more than 518,076 outpatient visits, more than 141,328 emergency room visits, 627 beds, and more than 25,000 inpatient admissions annually. The hospital maintains a strong academic affiliation with SUNY Downstate Health Sciences University to maintain its high standards of healthcare delivery. The Mission of NYC Health + Hospitals is to extend equally to all New Yorkers, regardless of the ability to pay, comprehensive health services of the highest quality in an atmosphere of humane care, dignity, and respect. Their Values are built on a foundation of social and racial equity and have established the ICARE standards for all staff. NYC Health + Hospitals is the nation’s largest municipal healthcare delivery system in the United States. Dedicated to providing the highest quality health care services to all New Yorkers with compassion, dignity and respect, regardless of immigration status or ability to pay. Opportunity Details: • Senior level leadership position., • Manage the provision of patient care to an ethnically and socially diverse patient base., • Support the CMO in ensuring that standards, protocols, leadership, and direction exist to provide the highest quality of care possible to patients., • Assess and upgrade existing medical care standards., • Provide management, leadership, and coaching to all medical staff., • Work with operating and executive team members to implement new operating processes and systems., • Serve as executive sponsor to Root Cause Analysis (RCA) activities and execution of Corrective Action Plans (CAPs) and Risk Reduction Strategies (RRS)., • Oversee Hospital Ethics., • Board Certification in a medical specialty., • Physician (MD or DO) with an active New York State Medical License., • At least 5 – 10 years of experience providing medical direction and supervision to teams of medical staff., • Must have experience developing and implementing standards of care, medical protocols, quality assurance standards and monitoring, and professional training and education., • Must have experience implementing new clinic operating processes and systems aimed at improving efficiency., • Strong leadership and change management skills., • Understanding of regulatory and accreditation requirements, including but not limited to DOH, CMS, TJC, etc., • Understanding of legal issues, medical malpractice, and patient safety issues related to the delivery of healthcare., • Working knowledge of current hospital policies and procedures., • Ability to identify areas that require further research based upon organizational trends and activities., • Ability to nurture an environment that encourages teamwork and collaboration, both internally and externally. Wages and Benefits include: Annual Base Salary: $325,000* based on a 40-hour work week. The annual total value of compensation package is estimated at $357,500**, which includes the baseline salary, 401(k) contribution, and other factors as set forth below: • 401(k) Company Contribution (subject to IRS contribution limits):, • Employees are immediately vested in a 3% company contribution of base earnings. No employee match is required., • After one year of service, employees receive an additional 7% company contribution of base earnings. No employee match is required., • Annual Continuing Medical Education (CME) Reimbursement., • Generous Annual Paid Time Off (PTO): Vacation, Sick, Holiday, and CME days., • Medical, Prescription, and Dental Coverage: Top-tier plans with employee contributions significantly below market rates., • Life Insurance and Accidental Death and Dismemberment (AD&D) Coverage: Equal to 2x your salary (up to a maximum of $300,000) provided at no cost to you., • Additional employee-paid Voluntary Life and AD&D coverage is available for you and your family., • Medical Malpractice Coverage (equivalent to occurrence-based): Provided at no cost to the employee., • Healthcare and Dependent Care Flexible Spending Accounts (FSAs)., • Pre-tax employee-paid contributions for commuting expenses. Physician Affiliate Group of New York, P.C. (PAGNY) mission is to provide accountable, responsive, quality care with the highest degree of sensitivity to the needs of the diverse population that lives in our New York community. PAGNY is one of the largest physician groups in the country and directly employs nearly 4,000 physicians and allied health professionals who provide services to NYC Health + Hospitals, the largest municipal health care system in the nation serving more than a million New Yorkers annually. Our providers are highly skilled professionals with outstanding credentials who deliver the highest level of quality healthcare to patients throughout New York City. Physician Affiliate Group of New York, P.C. (PAGNY) is an equal opportunity employer committed to equitable hiring practices and a supportive workplace. All candidates are considered based on their individual qualifications, potential, and experience. To learn more about our culture and ongoing workplace practices, please visit our ___. *Salary Disclosure Information: The salary listed for this position complies with New York City's Salary Transparency Law for Job Advertisements. The salary applies specifically to the position being advertised and does not include potential bonuses, incentive compensation, or benefits. Actual total compensation may vary based on factors such as experience, skills, qualifications, historical performance, and other relevant criteria. **The annual total value of the compensation package shown is provided as an illustration and is not guaranteed

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. QuidelOrtho is seeking a Manager, Data Analytics. The Manager, Data Analytics is a global people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role provides strategic direction and operational oversight across Quality disciplines. operate under little to no direct supervision and provide independent guidance to the business. This position is considered a subject matter expert in Quality Data Analytics and Complaint Trending. They are accountable for the work of the Quality Data Analytics team and the success of team projects; and will have significant amounts of critical organizational and technical knowledge. This leader is responsible for the day-to-day management and supervision of Quality Engineers and Data Analysts and is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance. By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Manager, Data Analytics ensures that Quality systems and teams deliver sustainable business and compliance outcomes. This position will be Hybrid in any global QuidelOrtho site. * Provides independent guidance to business partners on quality data handling and analytics. Establish dashboards and data visualizations to support product quality and continuous improvement. * Leads metrics and data analytics work for Complaints, Recalls, NC, CAPA, Audits/Compliance and other areas of Quality. * Ability to manage complaint trending activities and related software system validations * Ability to compile and present quality data and analysis to the business eg: Management Review. * Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives. * Establishclear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs. * Provide technical, regulatory, and operational leadership to ensure Quality systemscomply withISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements. * Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. * Promote a culture of continuous improvement byidentifyingopportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS). * Ensure the teammaintainsa state ofinspectionreadiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits. * MonitorQuality performance using metrics and data analytics toidentifyrisks, drive root cause analysis, and implement sustainable improvements. * Coach and mentor emerging Quality team members to build organizational capability and ensure robust succession planning. * Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders. * Ability to identify and drive process improvements; own process investigations, nonconformance records or corrective actions in response to audit findings. * Perform other work-related duties as assigned. Required: * Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required. * 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership. * Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR. * Proven ability to lead and develop high-performing teams and build future technical and people leaders * Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations. • Excellent collaboration, influence, and communication skills across functional and organizational boundaries., • Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement., • Experience leading in a matrixed, global organization and managing competing priorities effectively., • Commitment to scientific integrity, compliance excellence, and continuous improvement. Preferred: * Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. * Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools. * Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise. * Experience supporting or leading Health Authority or Notified Body inspections. Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. Typical office or laboratory environment. May involve virtual collaboration across multiple global sites. No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: * Thrive Together - Collaborate intentionally, grow as a team * Make It Happen - Focus on priorities, embrace continuous improvement * Commit to Service - Cultivate a service mindset * Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $135,000 to $175,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___. #LI-SP1

Transactional Construction Associate Attorney Needed for Growing AM 100 Law Firm!! This Jobot Job is hosted by: Bryce Koelsch Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $180,000 - $350,000 per year A bit about us: We are a leading AM 100 Law Firm specializing in corporate and business law, complex litigation, intellectual property, regulatory matters, and government affairs and employing some of the best and brightest attorneys. We are currently on the search for a mid to senior level Transactional Construction Attorney to join our New York office. In this position you will be responsible for: • Representing owners and developers in all phases of the construction of residential and commercial construction, • Drafting and Negotiating design, engineering, consulting and construction agreements Why join us? As a Transactional Construction Attorney in our company, we are able to offer the following: • Competitive base salary commensurate with experience!, • Paid Holidays, Vacation and Sick Time!, • 401k plan!, • Profit Sharing! Job Details As a Transactional Construction Attorney on our team, we are looking for the following experience: • JD from accredited law school, • Admitted to New York Bar, • 5+ years as a practicing attorney with experience representing owners and developers in all phases of the construction of commercial and residential real estate, • Strong working knowledge of construction case law and the New York Lien Law, • Transactional real estate experience – in the areas of development, acquisitions and dispositions, leasing, and/or financing – is a plus! Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy

Role Overview As Privacy Counsel, you will serve as a senior legal advisor on complex privacy, data protection, and cybersecurity matters for a New York City government agency. This role demands a seasoned attorney who can operate independently, advise senior leadership, and drive privacy initiatives across a large, multi-agency environment. Key Responsibilities Legal Advice & Counsel • Provide expert legal advice on complex, sensitive, and urgent privacy, data protection, and cybersecurity matters related to agency priority initiatives, • Advise on federal, state, and local privacy laws and regulations impacting city agencies and citywide initiatives, • Shape, draft, and review privacy-related policies, legislation, and citywide guidance, • Develop policies, guidance materials, templates, presentations, and training documents to support agency compliance with privacy laws and regulations, • Represent agency leadership in national and international privacy organizations, interagency working groups, and senior-level meetings, • Manage relationships and drive intergovernmental affairs with executive offices, legislative bodies, and key government stakeholders on privacy matters, • Prepare legal briefs and provide strategic advice to government officials and city leadership on privacy matters, • Handle special projects and initiatives as assigned by program leadership Mandatory Qualifications • Minimum 12 years of legal experience, including experience in government, intergovernmental affairs, or implementing and supporting an enterprise privacy program, • Admission to the New York State Bar, in good standing, • Active IAPP certification (e.g., CIPP/US, CIPP/E, CIPM, CIPT, or AIGP), • Demonstrated, hands-on experience advising on complex U.S. privacy and data security laws (e.g., GDPR implications for U.S. entities, CCPA/CPRA, HIPAA, state breach notification laws, and relevant federal, state, and local statutes), • Experience drafting, reviewing, and negotiating privacy-related legal documents including MOUs, NDAs, data sharing/processing agreements, and terms of service, • Track record developing organizational privacy policies, compliance materials, internal/external legal guidance, and templates, • Experience conducting or providing legal support for privacy impact assessments, data protection impact assessments, or similar privacy risk analyses, • Demonstrated ability advising on privacy and data security implications of emerging technologies, digital services, or data use initiatives, • Experience supporting implementation or operation of an enterprise-level privacy program, • Ability to monitor, analyze, and advise on privacy-related legislative and regulatory developments, • Proven ability to provide strategic legal counsel to senior leadership and executive-level stakeholders, • Excellent written and verbal communication skills with the ability to convey complex legal and policy concepts to diverse audiences, including non-legal and technical stakeholders, • Demonstrated ability to collaborate effectively within interdisciplinary teams (IT, policy, operations, legal) to develop and implement privacy solutions Preferred Qualifications • Experience working as an attorney within a government agency (federal, state, or local), or providing extensive direct legal counsel to government agency clients, • In-house experience at a large, complex enterprise or highly regulated industry where policy, legal considerations, and operations frequently intersect Job Type: Contract Pay: $70.00 - $85.00 per hour Expected hours: 35 per week Experience:

A leading-edge financial technology company transforming the way companies raise capital is seeking a highly motivated General Counsel to lead all legal, regulatory, and risk affairs while supporting rapid growth. Who you are You are a driven legal leader with an established track record in the fintech or high-growth technology sector. You don’t just provide legal advice; you are a pragmatic, enabling, and decisive leader who operates with a bias for action and a clear focus on strategic and commercial objectives. You possess the confidence and expertise to identify issues, advise on complex high-stakes matters at the executive level, and project-manage the execution of risk mitigation strategies. Having navigated the legal challenges of significant corporate and commercial activities, you view compliance as an enabling foundation for differentiation and expansion rather than an obstacle. You are inherently resourceful, innovative in applying technology to legal problems, and committed to building a world-class legal function with a strong collaborative mindset aligned with executive leadership and the broader business. What you will do As General Counsel, you will play a key role in shaping the legal and regulatory strategy of a fast-growing financial technology platform. You will have the opportunity to: • Own the Legal Strategy: Build, mentor, and scale a high-performing legal function, defining departmental strategy and managing the legal budget., • Drive Technology Innovation: Champion the adoption of artificial intelligence and modern legal technology to increase the efficiency and impact of the legal function., • Partner with Executive Leadership: Serve as a strategic advisor to the executive team on major decisions impacting the business and its growth., • Navigate the Regulatory Environment: Lead engagement with regulators and policymakers while helping shape evolving regulations impacting digital capital formation., • Protect Strategic Assets: Advise on technology, data, and intellectual property strategies to maintain competitive advantage., • Operate in a High-Growth Environment: Support a fast-moving organization where compliance and risk management enable expansion. What skills you need • Minimum of 8+ years of progressive legal experience, including significant in-house experience at a high-growth technology, fintech, or capital markets company., • Experience building, leading, and developing legal teams., • Exceptional ability to translate complex legal matters into clear, actionable advice for business leaders.

Senior Director of Labor, as part of the General Counsel’s Office, is responsible for analyzing, managing, and advising on labor and employment matters for the organization and ensuring compliance with the Company’s obligations under various collective bargaining agreements. Responsibilities: • Manage legal affairs related to labor issues including litigation, arbitration, and ensuring compliance with all applicable statutory and regulatory requirements., • Negotiate and draft collective bargaining agreements and memoranda of understanding, provide advice and counsel regarding applicable collective bargaining agreements and engage union representatives to address matters related to the CBAs., • Represent the organization in state and federal court, before administrative tribunals and governmental bodies, and during bargaining sessions with unions., • Draft position statements, policies and procedures, and various corporate related documents., • Supervise/monitor the activities of retained outside counsel., • Provide leadership, guidance, and support to a team of labor specialists who manage employee issues including disciplinary matters, investigations and other labor/employment matters., • Mitigate Company’s risk and liability through compliance with applicable laws and regulations., • 5 days per week on site required. Qualifications: • Law Degree from an accredited law school., • Licensed and registered to practice law in New York State., • Eight or more years of relevant, progressive experience as a practicing attorney required., • Labor and Employment litigation/arbitration experience and negotiation skills required., • Experience in unionized healthcare organizations required., • Labor and employment law knowledge and experience with applicable federal and state laws and regulations required., • Ability to operate independently with minimal supervision and address a variety of legal issues., • Excellent interpersonal and communication skills. Ideal candidate will be a quick study; able to think strategically while also being detail- oriented; work well under pressure and able to juggle multiple priorities; have excellent interpersonal, speaking and writing skills; a strong academic background; excellent analytical and advising skills; and demonstrated judgment and discretion. Looking for someone to take a hands-on role within a small but dynamic legal department. Annual Salary = $180,000 to 220,000.00

Experienced Clinical Research Associate - Full-Service - Oncology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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 Compliance Summer Intern will support the Compliance department in key operational, strategic, and crossfunctional initiatives. This role offers a unique opportunity for a student interested in pharmaceutical compliance, risk management, systems/process implementation, and other operational projects. The intern will gain handson experience working alongside Compliance business partners while contributing to meaningful projects that support Eisai's commitment to ethical business practices and patientcentered decisionmaking. Key Responsibilities • Support system implementation activities, including documenting business requirements, testing new system functionalities, and assisting in user acceptance testing (UAT)., • Assist with policy and training updates, including drafting content, organizing reference materials, and helping prepare communications., • Participate in team meetings and project working sessions., • Currently enrolled in an undergraduate or graduate program in Business, Legal Studies, Public Health, Regulatory Affairs, Life Sciences, Healthcare Administration, or related fields., • Demonstrated interest in compliance, healthcare/pharmaceutical regulation, or corporate ethics., • Strong analytical, organizational, and problemsolving skills., • Excellent written and verbal communication abilities., • Ability to manage multiple tasks, meet deadlines, and collaborate with team members., • How a Compliance department operates within a pharmaceutical organization., • Key elements of healthcare laws, regulatory requirements, and industry standards that govern pharma interactions and operations., • Best practices in governance, monitoring, training development, and risk mitigation., • Practical experience supporting a system implementation or enhancement project., • Direct exposure to real projects that support business needs., • Handson experience in a missiondriven organization committed to patients and ethical conduct., • A blend of operational work, strategic thinking, and professional development., • A strong foundation for students interested in careers in healthcare compliance, regulatory affairs, risk management, or corporate governance. Eisai Salary Transparency Language: The hourly rate for the Compliance Summer Intern (Hybrid - Nutley, NJ) is : $25. 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:

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. Support regulatory submission/publishing activities for eCTD global submission dossiers according to Agency and ICH Guidance requirements for major filings, (IND, NDA, sNDA, Amendments, DMFs, etc.) and regulatory maintenance activities. Support global submission timelines and coordination of publishing activities of work-related experience required for this position. Solid knowledge of submission requirements for regional markets may be required to ensure the overall submission and quality of the dossier meets regulatory compliance. Essential Functions Submission Management & Publishing Tasks: Manage assigned regulatory activity projects and closely collaborates with Senior Managers from GSM, Regulatory Affairs and other functional areas for the planning and publishing of regulatory submissions, monitoring submission forecast and ensuring timely high quality of regulatory submissions are submitted to health authority within required submission timelines. Publishing regulatory submissions (bookmarks, hypertext links, QC) scheduled to be submitted to regulatory agencies (e.g., FDA, EMA and Health Canada). Publishing Tasks: Assists with hands-on daily submission compilation and publishing activities associated with preparation of various dossier types Submission Specialist Tasks: • Responsible for publishing, review, submission compilation and archive for routine regulatory activities (e.g. Amendments) and complex eCTD submissions (e.g. IND, NDA)., • Uses internal and industry best practices in order to ensure quality submission deliverables., • Provide operational oversight to ensure timely, high quality regulatory submissions, • Participates in the development of optimal business processes (internal guides, SOPs, etc.) and practices within the department to ensure high levels of customer support and to achieve high quality submissions. Identifies and advises management with regards to opportunities for efficiencies, business process improvements, and cost reductions., • Position accountability/scope includes supervision of certain projects and assistance with priority setting required. Receives project assignments from manager, but has the responsibility for independently managing and executing own projects. Reviews project progress with manager on a regular basis with direction provided on follow-up., • Identifies opportunities and advises management for process improvements or cost savings. May participate on internal project teams in order to guide and update business processes., • Supports various document management assignments, including file transfer, archiving, tracking, and archival of Regulatory submission documentation (including SPL, FDA correspondence and submission)., • Demonstrates team leadership skills and ability to positively influence and work with others. Builds and maintains positive relationships internally and externally., • Participates in other key projects and activities as assigned by management to support the Regulatory Operations function including submission authoring and Regulatory Systems implementation projects. Publishing Tasks: Assist with hands-on daily submission compilation and publishing activities associated with preparation of various regulatory submission types. Applies good judgment and demonstrates initiative to resolve issues. • Expert understanding of Project Management tools and techniques., • Ensures publishing activities are processed in accordance with established SOPs., • Collaborate timeline with the regulatory affairs representatives, maintains the submission timelines, obtain status updates from the Publishing Manager and subteam members, RA Leads and reports submission status and activities to various stakeholders., • Update the regulatory submission calendar, and reports on key submission milestones to stakeholders, as applicable. Business Process Development & Problem Solving: • Participate and contribute to new and updated process and procedures. Review regulatory documents to ensure compliance with submission guidelines to drive efficient future state process including gaining buy in for key stakeholder and drive to standardization of processes., • Identifies risks and opportunities and addresses as needed with a focus on regulatory compliance requirements by supporting best practices, Working Procedures and SOPs., • Support process updates due to changing regulations that impact submission strategies and technologies, SEND, CDISC, Validator Software, etc. This includes not limited to identifying the validation checks needed to ensure compliance with eCTD Specifications for world-wide regulatory agencies., • May participate on internal project teams in order to guide and update business processes, as applicable. Regulatory Information Applications & Technology: • Support technology activities to ensure that regulatory information applications and systems are implemented, validated, and maintained in accordance with regulatory requirements compliance including but not limited to performing UAT scripts)., • Support Global System development and process development on a basic level, and process redesign., • Technical knowledge of the US and global regulatory requirements for electronic submissions Regulatory Training: Support and coordinate training to global submission management, regulatory publishing and other functional areas. Regulatory Submission Intelligence: Perform and collect regulatory information applicable to global electronic submissions guidance, publishing tasks, data standards, and technology and marketing trends in regulatory space. Ability to gather data, analyze research material information and communicate to management potential impact on regulatory operations strategies, and/or identify hot topic issues. Responsible for staying abreast of US, Harmonized (ICH) eCTD and Global guidances, and provide updates as required Requirements • Bachelor's Degree required, preferably in science or health related discipline, • Minimum 3-5 years pharma experience, including at least 1-2 years submission experience, • Experience regulatory professional that understands regulatory submission/ePublishing requirements for filing original applications, amendments, complex supplements/variations and line extensions, as well as routine submissions., • Excellent communication skills required to interact effectively with regulatory affairs members and regulatory colleagues in gathering the necessary information required for submissions, and to proactively address sensitive issues with diplomacy and tact., • Applies good judgment and demonstrates initiative to resolve issues., • Advance understanding of Submission Project Management tools and techniques., • Ensures submissions are processed in accordance with established SOPs., • Excellent analytical and problem solving skills: facilitating team(s) to identify issues and propose solutions with respect to regulatory eCTD submission issue, • Strong Communication Skills: Excellent verbal and written communication skills with demonstrated ability to present and articulate requirements with regulatory affairs members and regulatory colleagues proactively. Ability to foster and maintain relationships with strategic global regulatory organization and other functional partners to ensure understanding of current processes., • Project Management Skills: Strong project management skills with attention to detail, ability to work in a fast-paced environment while successfully prioritizing and working on multiple tasks while utilizing organizational skills., • Knowledge of Drug Development: Experience in regulatory operations or regulatory affairs with advanced knowledge of pharmaceutical development (e.g. CMC, Nonclinical, Clinical), • Technology & Software Skills: Advanced working knowledge of global eCTD publishing and Electronic Document Management technology, ISI Toolbox, Regulatory Tracking Systems (RTS) and related technology applications. Advanced user skill in MS Word, MS Sharepoint, Adobe Acrobat Professional, eCTD content templates and experience., • Teamwork Skills: Experience in working on teams and to establish effective relationships with team members., • Critical Thinking and Problem Solving Skills: Ability to track regulatory eCTD submission changes (e.g. regional DTD upgrade or system upgrades) and interpret potential implications for regulatory activities, training and/or timelines. Ability to identify the root cause of problems as well as the implications associated with potential solutions and communicate to management. Eisai Salary Transparency Language: The annual base salary range for the Senior Associate, Global Submission Management is from :$82,500-$108,300 Under 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:

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 Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS: Product/Therapeutic Area Support to Stakeholders • Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests., • Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data, • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives, • Serve as technical/scientific subject matter resource to Eisai cross functional partners, • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performance evaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning., • Ability to lead and motivate team members without a direct reporting relationship Research Support • Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials., • The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: • 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title., • Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred., • 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred, • Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required., • Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: • Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs., • Committed to the concept of team and working within the framework of the Medical Affairs., • Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately., • Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately., • Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs., • Has an ability to work independently and not require close supervision while adhering to compliance/regulatory policies., • Interest in leading and participating in projects while effectively balancing field work., • Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them., • Seamlessly adapts to field situations and effectively problem solves within your territory., • Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies, • Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing, • Possesses and maintains a valid driver's license and clean driving record., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 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:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL), Alzheimer's Disease (Northern CA) - Field Based is from :$160,100-$210,100 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:

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 Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS: Product/Therapeutic Area Support to Stakeholders • Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests., • Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data, • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives, • Serve as technical/scientific subject matter resource to Eisai cross functional partners, • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performance evaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning., • Ability to lead and motivate team members without a direct reporting relationship Research Support • Facilitate review and follow up of submitted Investigator-Initiated Studies (IISs) and assist with Eisai sponsored trials., • The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: • 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title., • Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred., • 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred, • Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are required., • Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: • Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs., • Committed to the concept of team and working within the framework of the Medical Affairs., • Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately., • Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately., • Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs., • Has an ability to work independently and not require close supervision while adhering to compliance/regulatory policies., • Interest in leading and participating in projects while effectively balancing field work., • Demonstrated ability to proactively identify opportunities/challenges, willingness to communicate these challenges to leadership while working together to overcome them., • Seamlessly adapts to field situations and effectively problem solves within your territory., • Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies, • Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing, • Possesses and maintains a valid driver's license and clean driving record., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 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:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the MSL/Senior Medical Science Liaison, Neurology (Alzheimer's Disease) - Field Based, Northern and Central Florida - Field Based is from :$165,300-$216,900 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:

Principal/Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA/Canada Remote Based Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities *Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. *Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed. *Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk. *Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles. *Serves as project lead for deliverables of assigned complex and/or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable. *Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process. *Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices. *Performs quality review of assigned documents to ensure accuracy. *Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. *Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. *May compile medical writing deliverables. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $62,000.00 - $108,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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 Profile Summary The Associate Director, Medical Information Oncology, is responsible for leading and driving Global & US Medical Information activities for assigned therapeutic area(s) to meet the Eisai product information needs of external customers and internal business partners. This role is seen and sought after for their subject matter expertise in Oncology and assigned therapeutic area(s) and serves as medical reviewer of Eisai's advertising, promotional, and scientific exchange materials as part of Copy Review Committee and Medical Review Committee. Beyond traditional responsibilities, this position offers a unique opportunity to optimize and communicate medical information insights as part of a broad, cross-functional strategic team, ensuring these insights inform decision-making and drive innovation across the organization. The Associate Director will also leverage and implement AI-driven tools and capabilities in new and transformative ways, enhancing efficiency, personalization, and scalability of medical information services. The AD, Medical Information contributes to the development and implementation of medical plans, including the creation of standard medical responses, development of AMCP dossiers, compendia submissions, and other medical information deliverables. This role is also responsible for oversight or management of Medical Information Specialists/Managers, budget management of assigned activities, contributing to performance improvement activities, conducting quality monitoring, tracking and reporting of medical information insights and metrics, ensuring regulatory compliance, inspection readiness, and appropriate documentation and reporting of product incident reports. Responsibilities (Expanded) * Develop and manage tactical execution of the Medical Information component of Global & US Medical Affairs strategic plans for assigned therapeutic area(s). * Develop and ensure high-quality, balanced, and scientifically accurate documents in response to medical inquiries from external customers and internal stakeholders; conduct quality assurance measures and handle escalated inquiries as needed. * Lead and drive the development of Medical Information deliverables, including research and analysis of the scientific literature, standard medical responses (SMRs), verbal responses to FAQs, AMCP dossiers, compendium and pathways submissions, etc. * Serve as medical reviewer, ensuring medical accuracy and provision of feedback for Eisai's advertising, promotional, and medical materials as part of Copy Review Committee and Medical Review Committee. * Lead and provide oversight of department reporting processes, KPIs, insights analytics, digital analytics, and other trend reports that are shared with internal stakeholders; proactively identify opportunities to optimize insights for strategic decision-making. * Explore and implement AI-driven tools and technologies to enhance medical information processes, improve efficiency, and deliver innovative solutions for internal and external stakeholders. * Liaise with global and regional medical affairs colleagues as appropriate. * Provide strong scientific support for conference and booth coverage. * Implement and participate in department training, process and performance improvement activities, quality monitoring, metrics tracking, regulatory compliance, inspection readiness, and product incident response. * Serve as a business partner to internal and external collaborators as needed to support scientific exchange activities and address critical escalations as warranted. * Provide mentoring, guidance, and training to new hires/less experienced colleagues. * May provide direct supervision of Medical Information Sr Managers, Specialists, and contractors, as appropriate. * Travel required up to 30% of time. * Hybrid based in Nutley, NJ (in office Tuesday, Wednesday and Thursday) Qualifications: * Advanced degree in sciences or related field with 10+ years of experience in the pharma/biotech industry OR a combination of equivalent education and experience. * Strong scientific knowledge and expertise in Oncology, including evaluating and communicating clinical trial and disease state information to a wide range of audiences. * Demonstrated experience in conducting scientific literature review, and management of medical inquiries, including the development and review of medical information deliverables (e.g., standard medical response documents, FAQs, dossier, compendium submissions, etc.) * Practical experience and knowledge of FDA guidance on appropriate scientific exchange practices. * Previous experience of managing/leading teams directly/indirectly or 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. Additional Preferred Qualifications: * Experience with AI tools, digital innovation, and data analytics to enhance medical information processes and insights. * Ability to identify and implement emerging technologies to optimize workflows and deliver innovative solutions. * Strong understanding of data visualization and insights reporting to support strategic decision-making. 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 Associate Director, Medical Information, Oncology is from :$164,600-$216,100 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:

Experienced Clinical Research Associate - Full-Service - Ophthalmology Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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.* Able to travel as needed (approximately 10% on average)* 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-$171,300 Under 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:

Venable LLP's New York Real Estate Group seeks a mid- to senior-level Construction Associate with at least five years of experience advising clients on construction projects. The ideal candidate will have significant law firm experience representing owners and developers in all phases of the construction of commercial and residential real estate. Required experience includes drafting and negotiating design, engineering, consulting, and construction agreements, as well as right of entry and access agreements, and closeout agreements. Candidates should also have experience resolving construction-related disputes outside of arbitration and litigation, and advising clients on construction claims. A strong working knowledge of construction case law and the New York Lien Law is essential. Transactional real estate experience - in the areas of development, acquisitions and dispositions, leasing, and/or financing - is a plus. The successful candidate will have exceptional oral and written communication skills, particularly strong drafting ability, and outstanding academic credentials. Candidates must hold a Juris Doctor degree from an accredited law school and be admitted to and in good standing with the bar of the State of New York. In addition to a solid record of professional achievement, the candidate should demonstrate an interest in participating in client education initiatives and business development presentations, as well as providing mentorship to junior associates and contributing to firm citizenship activities. Please include a law school transcript, deal sheet, and original writing sample with submissions. Venable LLP is an American Lawyer Global 100 law firm headquartered in Washington, DC, with offices in California, Colorado, Delaware, Florida, Illinois, Maryland, New York, and Virginia. Our lawyers and legislative advisors serve domestic and international clients in all areas of corporate and business law, complex litigation, intellectual property, regulatory matters, and government affairs. Additional information can be found at Venable.com. The salary range for associate positions is $215,000 to $355,000. The actual salary offered will be based on a number of job-related factors including, but not limited to, years of related experience, level of education, skills, credentials and certifications, responsibilities and performance. Venable LLP does not discriminate on the basis of race, gender, ethnicity, religion, national origin, age, disability, veteran status, or on any other basis prohibited by law. To view our inclusion and opportunity policy, please click ___. Contact: Elizabeth Bart Associate Recruiting Manager

• Job Type: Officer of Administration, • Bargaining Unit:, • Regular/Temporary: Regular, • End Date if Temporary:, • Hours Per Week: 35, • Standard Work Schedule: M-F, • Building: The Divisional Administrator - Level II serves as the operational and administrative leader for the Divisions of Child Neurology and the CP Center within the Department of Neurology. Reporting to the Division Chief and partnering with departmental leadership, this role oversees clinical operations, research administration, finance, faculty affairs, and compliance to support the division's missions of patient care, education, and research. The position acts as a key advisor to physician leaders, ensuring efficient operations, financial stewardship, and regulatory compliance. Responsibilities Financial • Partner with the Division Chief to lead implementation of divisional strategy and operational initiatives., • Oversee divisional budgets and financial performance across clinical practice, faculty compensation, and sponsored research., • Monitor budget variances; identify and drive financial improvement, business development, and strategic planning initiatives., • Work collaboratively with the Department Administrator/COO on strategic plans for growth initiatives and physician compensation models., • Lead the creation and execution of recruitment and replacement business plans., • Create, negotiate, and maintain master service agreements with outside vendors., • Identify, implement, and monitor cost-saving and efficiency initiatives in collaboration with divisional and departmental leadership., • Approve and administer expense reimbursements for faculty and staff., • Manage all day-to-day activities of the division; independently resolve operational issues; continuously monitor and optimize workflows; assign work and special projects to administrative staff., • Oversee space planning, utilization, IT coordination, renovations, and moves., • Lead collaboration with the HR pod and VP&S Onboarding team for hiring, appointments, promotions, salary allocations, and faculty credentialing., • Serve as a primary advisor to staff and faculty regarding HR policies and employee relations matters., • Manage staff performance, including annual evaluations and implementation of performance improvement plans., • Directly supervise and develop divisional administrative staff., • Ensure divisional compliance with institutional policies, healthcare regulations, and sponsored research requirements., • Proven ability to manage complex operations and financial portfolios., • Strong physician relations and leadership communication skills. Columbia University is committed to the hiring of qualified local residents.

Eaton Fiber is building a 100% fiber network to support the next generation of broadband services. Eaton Fiber is a portfolio company of Tillman Global Holdings, a holding company focused on building premier digital infrastructure businesses globally. We have an incredible opportunity for a Contract Specialist , who will report directly to the VP, Procurement Position Summary The Contract Specialist is responsible for supporting the full contract lifecycle across Eaton Fiber’s operations, including vendor agreements, construction and engineering contracts, municipal agreements, right-of-way agreements, and professional services contracts. This role works cross-functionally with Legal, Finance, Operations, Engineering, and External Affairs to ensure contracts are accurate, compliant, and executed efficiently to support rapid network deployment. This is a full-time on-site role in Bergen County, NJ. Key Responsibilities • Draft, review, track, and administer a high volume of contracts, amendments, and related documents, • Manage contract lifecycle from initiation through execution, compliance, and close-out, • Coordinate with internal stakeholders to ensure contract terms align with business, operational, and financial objectives, • Support contracts related to fiber construction, engineering services, permitting, pole attachments, ROW access, material distribution, vendors, and consultants, • Maintain contract repository and ensure accurate documentation, version control, and audit readiness, • Track key contractual obligations, deliverables, renewal dates, and expirations, • Assist with compliance requirements, including regulatory, insurance, and vendor onboarding documentation, • Support negotiation preparation by identifying risks, inconsistencies, and non-standard terms, • Interface with outside counsel and vendors as needed, • Continuously improve contract processes, templates, and workflows to support company growth Qualifications • Bachelor’s degree required; degree in Business, Supply Chain, Legal Studies, Finance, or a related field preferred., • 3–5 years of experience in contract administration, contract management, or legal operations, • Experience in telecom/fiber required, • Strong understanding of contract terms, risk mitigation, and compliance concepts, • Exceptional attention to detail and organizational skills, • Ability to manage multiple priorities in a fast-paced, deadline-driven environment, • Experience supporting municipal, right-of-way, or public-private partnership agreements preferred, • Familiarity with fiber deployment, construction contracts, or telecom regulatory environments, • Strong aptitude to learn and effectively use enterprise IT systems and business platforms

Experienced Clinical Research Associate - Full-Service Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes., • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues., • Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements., • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned., • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations., • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution., • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets., • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements, • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements., • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills and be able to embrace new technologies, • Excellent communication, presentation and interpersonal skills, • Ability to manage required travel of up to 75% on a regular basis, • US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Supports the Commercial & Private Bank Business Risk & Controls Officer – Compliance Risk Officer in the interaction with the following Business Unit partners: Bank Examiners, External Bank Auditors, Enterprise Compliance & Risk Management, Internal Audit, Regulatory Affairs, Business Process Owne

Venable LLP's Patent Prosecution and Counseling group seeks a patent agent with an aerospace engineering background and experience with engine technology to join the group working exclusively on technology prosecution matters in the Washington, DC or New York office. The qualified candidate is a registered patent agent with examining experience at the USPTO or patent drafting experience in a law firm setting. The ideal candidate is seeking an opportunity to use their deep technical knowledge to work exclusively on patent prosecution and holds undergraduate and/or graduate degrees in aerospace engineering or mechanical engineering. Industry experience is a plus. Candidates must have excellent academic credentials, strong writing skills, and sharp analytical ability. All submissions must include a brief cover letter indicating office of interest, and undergraduate, and graduate school transcripts as applicable. With a deep bench of former patent examiners and attorneys with industry experience and advanced technical degrees, Venable is one of the nation's leading patent law firms. Our patent prosecution work is reinforced by a strong corps of patent strategists and patent litigators skilled at advising clients on maximizing the value of their intellectual property portfolios. Venable LLP is an American Lawyer Global 100 law firm headquartered in Washington, D.C., with offices in California, Colorado, Delaware, Florida, Illinois, Maryland, New York, and Virginia. Our lawyers and legislative advisors serve domestic and international clients in all areas of corporate and business law, complex litigation, intellectual property, regulatory matters, and government affairs. Additional information can be found at ___. The salary range for this position is $160,000 to $180,000 per year, depending upon patent agent qualifications. Venable LLP does not discriminate on the basis of race, gender, ethnicity, religion, national origin, age, disability, veteran status, or on any other basis prohibited by law. To view our inclusion and opportunity policy, please click ___. Contact: Victoria Sievers Senior Manager of Associate Recruiting

• Job Type: Officer of Administration, • Bargaining Unit:, • Regular/Temporary: Regular, • End Date if Temporary:, • Hours Per Week: 35, • Standard Work Schedule:, • Building: The Department of Psychiatry at the Vagelos College of Physicians & Surgeons of Columbia University is a global leader in psychiatric care and operates across multiple affiliated organizations, including Columbia University, New York-Presbyterian Hospital, the New York State Office of Mental Health, and the Research Foundation for Mental Hygiene. Our mission encompasses clinical care, education, and research. The Department is deeply committed to innovation and excellence in clinical medicine, education, research, community and global health, as well as the professional development of our faculty and staff. This position will be a highly visible position, both internal and external to the Department and should prioritize the ethos, mission and goals of the Department of Psychiatry. This position will be on-site and in-person and will not be suitable for those seeking a hybrid or remote employment opportunity. This individual reports directly to the Department Administrator/COO for the Department of Psychiatry and will work closely with other Director level colleagues across the Department, while overseeing practice manager staff across multiple locations in Manhattan and Westchester. The ideal candidate will prioritize a team-based approach and should foster a dynamic and high functioning operations team in a complex and high paced environment. At CUIMC, we are leaders in teaching, research, and patient care and are proud of the service and support we provide to our community. Columbia University offers a range of benefits to help you, and your dependents stay healthy, build long-term financial security, meet educational and professional goals, and more. This position requires a fully onsite presence in our clinical practices. This position will require some travel to both Westchester and Manhattan based clinics and individuals will be expected to cover the cost of transportation to/from these sites. Responsibilities • Works in conjunction with Department Leadership and Chief Operating Officer to maintain healthy, efficient practices here at the Columbia University Medical Center campus, as well as offsite at locations throughout Manhattan and Westchester., • Responsible for standardizing protocols and workflow processes across all sites to ensure physician and patient satisfaction and high quality of healthcare service delivery across all clinical locations., • Serves as point of contact for daily operations issues at all sites across Department of Psychiatry, escalates issues as necessary to appropriate leadership., • Must be able to travel between sites across the Westchester/Manhattan area (as well as any future sites). Conducts site visits periodically to ensure that each site is acting in accordance with the Department and institution regulations and guidelines. Visits to ensure that all sites feel connected to the main campus., • Works with site and practice managers to address staffing needs, and to anticipate future growth opportunities., • Works with site and practice managers to understand workflow challenges and proactively provides solutions., • Financial oversight for offsite clinical locations: Responsible for reconciling and managing discretionary budgets related to operational and administrative expenditures across all site locations. Works with finance team and clinical leaders at each site to prepare and submit site specific budgets on a fiscal year basis while ensuring appropriate compliance and adherence to department and institutional policy., • Multi-site management and workforce leadership: Oversees Practice Managers to ensure patient workflow pathways are appropriately documented for each location and clinical program., • Organizational and workflow design and efficiency: Coordinates with senior clinical leadership and Patient Intake team and Call Center to ensure that patients are appropriately triaged and have access to the Columbia Doctors Psychiatry clinical services., • Healthcare Operations Leadership, • Ability to lead and sustain high-performing outpatient clinical operations across multiple sites., • Experience operating within complex academic medical center and multi-affiliate environments (University, hospital, state, foundation)., • Capacity to align operational execution with departmental mission, ethos, and strategic goals., • People Management & Team Development, • Proven ability to supervise and develop managers (e.g., Practice Managers) across geographically dispersed locations., • Skill in fostering a team-based, collaborative culture in a high-paced environment., • Experience addressing staffing needs, succession planning, and workforce growth proactively., • Decision-Making & Judgment, • Sound judgment in escalating operational issues appropriately., • Ability to balance standardization with site-specific operational needs., • Multi-Site Practice Operations Management, • Expertise in managing daily operations across multiple outpatient clinical locations., • Ability to standardize workflows, protocols, and patient pathways across sites., • Experience conducting site visits, compliance checks, and operational audits., • Process Improvement & Workflow Optimization, • Ability to identify workflow inefficiencies and design scalable solutions., • Experience documenting and maintaining standardized patient flow pathways., • Knowledge of operational best practices to enhance patient and provider satisfaction., • Financial & Budget Management, • Experience managing discretionary operational budgets., • Ability to prepare, reconcile, and monitor site-specific budgets in collaboration with finance and clinical leadership., • Understanding of fiscal compliance within institutional and departmental policy frameworks., • Health Information Systems & Data Literacy, • Working knowledge of EPIC and its role in clinical operations, access, and workflow management., • Cross-Functional Collaboration, • Ability to liaise effectively with clinical leadership, finance, HR, patient intake, call centers, and central administration., • Skill in coordinating across departments and affiliates to ensure alignment and streamlined processes., • Communication & Influence, • Clear, professional communication with internal and external stakeholders., • Ability to translate operational issues into actionable recommendations for senior leadership., • Strong interpersonal skills to build trust across clinical and administrative teams., • Compliance & Regulatory Awareness * Understanding of HIPAA, Joint Commission requirements, and institutional compliance expectations., • Ability to ensure site-level adherence to regulatory, privacy, and security standards., • Adaptability & Resilience, • Ability to manage competing priorities across multiple sites., • Comfort with frequent travel and on-site presence requirements., • Flexibility in responding to evolving operational and organizational needs., • Accountability & Service Orientation, • Strong sense of ownership for operational outcomes., • Commitment to patient access, quality, and service excellence., • Reliability as an essential, on-site leader in clinical operation., • Master's degree preferred., • EPIC Familiarity., • Must successfully complete online systems training requirements., • Strong organizational skills, ability to set priorities and manage multiple competing priorities concurrently., • High degree of attention to detail., • Foster credibility and establish collaborative working relationships with customers, management peers, and staff., • Clear and concise written and verbal communication., • Demonstrated working expertise with Microsoft Office products, especially proficiency with Excel., • Prior experience with complex budgeting, fiscal monitors and controls., • Proven ability to work on highly complex, time sensitive projects with limited direction, meeting critical deadlines., • Demonstrated acute attention to detail, critical thinking and judgement, as evidenced by minimal errors in complex reports., • Well-developed critical thinking skills., • Well-developed ability to exercise discretion., • Approaches situations with self-confidence., • Adaptable to diverse personalities and situations., • Can tolerate ambiguity., • Ability to have difficult conversations with grace and poise., • Good judgement: ability to think through a situation and plan a credible course of action. Columbia University is committed to the hiring of qualified local residents.

• Job Type: Officer of Administration, • Bargaining Unit:, • Regular/Temporary: Regular, • End Date if Temporary:, • Hours Per Week: 35, • Standard Work Schedule:, • Building: Reporting to the Program Director and with a dotted-line to the Associate Dean of Graduate Programs, the Deputy Program Director (Deputy) serves as an academic and operational leader within the School of Professional Studies. The incumbent assists in the management of program and curricular development efforts for the Degree Program. In the absence of the Program Director, the Deputy will serve as Columbia University's liaison to the academic, professional, and industry communities. The Deputy will support efforts to provide professional development opportunities for students enrolled in the Program and take an active leadership role in creating the strategic plan for key Program components such as Marketing, Admissions, Student Life, and Alumni Affairs. While initially assigned to support the M.S. in Project Management program, this role is structured to provide scalable academic leadership and may support additional academic programs or strategic initiatives as the School's needs evolve. Responsibilities • Works closely with Academic Affairs to build a culture of continuous assessment, using data to inform program review and strategic planning., • Responsible for faculty member's adherence to all academic policies put forth by the School and University., • Works closely with the Program Director and Admissions to review student applications and select the highest quality students for the program., • Works with the Program Director to provide oversight for the academic quality and administration of the Program., • Responsible for overall Program compliance to all regulatory, SPS, and University standards., • Provides oversight of quality and accuracy for yearly curricular planning submission as well as identifying areas for programmatic and curricular improvement; develops and implements an improvement/growth plan, working in conjunction with SPS's curricular design team to create and deliver courses in a variety of online and hybrid modalities., • Assists with the recruitment, appointment, teaching, and evaluation of faculty and students for the Program; responsible for working with full-time and part-time faculty to produce promotion and review dossiers., • Assists the Program Director to recruit, develop, manage, and retain industry relationships in support of the Program and students., • Works closely with the marketing team to create and execute strategic enrollment plans for the Program, actively participating in events to meet Program enrollment goals., • Works with the Program Director to represent Columbia University and the School in industry and professional communities., • Works with the Program Director and faculty to build program and practitioner eminence through publication (research, white papers), innovative industry development, new opportunities for professionals, network development, program growth, and/or recognition or accreditation., • Serves as liaison to the Career Design Lab and other School partners., • Contributes to strategic planning across Marketing, Admissions, Student Affairs, Alumni Affairs, and employer engagement., • May provide leadership or operational support to additional programs or School-wide initiatives as needed. Minimum Qualifications • Bachelor's degree required; advanced degree desirable, • 5 years of related experience, • Prior experience managing an academic program, • Project management skills, • Master's Degree or PhD, • Project Management Professional (PMP) certification or equivalent advanced credential, • Active engagement with PMI or comparable professional associations, • Demonstrated professional experience in the project management field, • Strong attention to detail and organizational skills required, • Strong customer service mentality, • Ability to be flexible in a changing environment, • Strong communication skills; ability to interface at all levels in the organization Columbia University is committed to the hiring of qualified local residents.

Title: Chief Compliance Officer Department: Office of Institutional Compliance Reports To: General Counsel, Senior Vice President of Legal Affairs and Secretary to the Board of Trustees Position Type: Staff Position Summary: The Chief Compliance Officer (CCO) serves as the senior executive responsible for overseeing and managing compliance with federal, state, and local laws and regulations as well as university policies and procedures. Reporting to the General Counsel, the CCO provides leadership in the development, implementation, and oversight of a comprehensive university-wide compliance program. This position ensures the university maintains a culture of compliance, ethical conduct, and risk awareness while fulfilling its academic and research mission. Essential Functions: Compliance Program Leadership: -Develop, implement, and maintain an effective, risk-based university compliance program. -Lead the coordination of compliance efforts across academic, administrative, and research units. -Monitor and report on the effectiveness of the compliance program to senior leadership and relevant university committees. Regulatory Oversight & Risk Management: -Ensure compliance with applicable laws and regulations (e.g., FERPA, Title IX, Clery Act, HIPAA, NCAA, ADA). -Partner with university stakeholders to assess and manage institutional compliance risk. -Stay abreast of regulatory changes and update compliance policies, procedures, and training accordingly. Training and Awareness: -Develop and deliver regular compliance training and education to faculty, staff, and students. -Promote a culture of ethics and compliance across the university community. Investigation and Reporting: -Oversee and coordinate internal investigations into reports of non-compliance or misconduct. -Maintain a confidential reporting system and ensure reports are addressed appropriately and promptly. -Prepare periodic compliance reports for the Board of Trustees and executive leadership. Policy Development and Review: -Lead or assist in the creation and revision of university-wide compliance-related policies and procedures. -Ensure alignment of policies with best practices and regulatory requirements. Collaboration and Leadership: -Serve as chair or member of university compliance-related committees. -Act as a liaison with external agencies on compliance matters and audits. -Provide expert guidance to university leadership on compliance risks and mitigation strategies. Other duties as assigned. Prerequisite Qualifications: -Education: Juris Doctor (JD) or advanced degree in law, compliance, public policy, higher education administration, or a related field required. -Experience: Minimum of 8-10 years of progressive experience in legal, compliance, or regulatory roles, preferably within a higher education, healthcare, or public sector setting. -At the university's discretion, the education and experience prerequisites may be exempted where the candidate can demonstrate to the satisfaction of the university, an equivalent combination of education and experience specifically preparing the candidate for success in the position. Preferred Qualifications: -Experience working in a university general counsel's office or comparable environment. Skills and Competencies: -Deep knowledge of laws and regulations affecting higher education institutions. -Proven ability to lead compliance initiatives in a complex university environment. -Exceptional communication and interpersonal skills. -Strong ethical judgment, discretion, and integrity. -Ability to work independently in a fast-paced environment. -Proficiency with compliance tracking tools and systems. Bargaining Unit: Non-Aligned Range/Band: 5 Salary Information: In compliance with the NJ Pay Transparency Law, the annual salary range for this position is $130,000-$150,000 (USD). NJIT considers factors such as (but not limited to) scope and responsibilities of the position, candidate's work experience, education/training, key skills, internal peer equity, as well as, market and organizational considerations when extending an offer. This pay range represents base pay only and excludes any additional items such as incentives, bonuses or other items. To learn more about the comprehensive benefits NJIT offers for this position, please visit our benefits page: . FLSA: Exempt Full-Time Travel: -<5% Apply NowShare Save Job

Prepare and maintain 510(k) submissions and other required regulatory filings, where applicable. Oversee product registrations, technical documentation, and regulatory records. Monitor evolving FDA, FTC, and other relevant regulatory requirements and provide practical guidance to internal stakeholde

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Job Description Job Title: Safety Advisor Department: Health, Safety & Environmental Affairs Reports to: Senior Manager, Production Safety or Client Representative Job Type: Temporary/Project-Based Pay Range: $2200 to $2900 per week Job Summary The Safety Advisor supports client health, safety and environmental programs for motion picture and TV productions and contributes to the safety culture and training of cast and crew. This includes compliance with regulatory requirements and advising on best practices in production safety. Key Responsibilities • Manage environmental, health & safety consulting service for client productions, • Evaluate production concepts, scripts, and pitches for safety and environmental concerns, • Collaborate with Production Executives, Producers, and Unit Production Managers to mitigate safety risks, • Support productions in planning and execution phases; assess safety needs and secure vendors, • Attend technical scouts and production meetings, • Develop and distribute the Production Injury and Illness Prevention Program (IIPP), • Mentor other safety professionals, • Evaluate sets, stages, and locations for safety issues and recommend corrective actions, • Respond to and investigate production incidents and emergencies, • Coordinate and deliver EHS training to production employees, • Promote safety culture and injury reduction initiatives, • Maintain relationships with industry safety bodies and regulatory agencies, • Resolve safety issues quickly during production, • Collaborate with risk managers and insurers on loss prevention, • Research applicable regulations based on filming locations, • Liaise with regulatory agencies and internal stakeholdersRequired Qualifications, • Must be local to the NYC area, • OSHA 30 certification, • Experience in studio or on-location production environments, • Deep understanding of TV and film production practices, equipment, and safety considerations, • Excellent organizational, verbal, and written communication skills, • Strong problem-solving skills, with the ability to work in a fast-paced environment, • Proficiency in Google Workspace, Microsoft Office, Zoom, WebEx, • Ability to work under pressure and handle confidential matters, • Ability to work at heights (catwalks, ladders, roofs, scaffolding, etc.), • Capable of handling tasks that demand physical strength and comfortable working outdoors in diverse weather conditions, • Ability to travel both domestically and internationally, • Must have or be able to obtain valid documentation for international travelRecommended Qualifications, • Bachelor’s degree in safety management, Industrial Hygiene, or related field, • BCSP (ASP, CSP, SME, etc.) or COHN, COHN-S certification, • Familiarity with applicable federal, regional, and local EHS regulations (OSHA, Cal/OSHA, EPA, etc.), • Facilities EHS and Production Safety hybrid experience, • CSATF Safety Advisor Training, • Certified Asbestos Building Inspector, • OSHA Certified Fall Protection Competent Person, • First Aid/CPRWork Environment & Physical Requirements, • Hybrid role with regular on-set presence required, • Domestic and international travel may be required, • Walk for extended periods and sit for long durations, • Work at heights (catwalks, ladders, roofs, scaffolding, etc.) Note: This job description is intended to convey essential job functions and requirements. It is not intended to be an exhaustive list of duties, responsibilities, or qualifications.

The Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional regulatory strategy, objectives, policies, and programs pertaining to developing and marketing Formation Bio’s assets. This role includes the lead regulatory responsibility for support of global r

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Collaborate with the AMER Regulatory Affairs department and Head Office partners (BPCE Group and Natixis) to plan and prioritize AMER IT Controls, Disaster Recovery Planning (DRP), and Security projects and initiatives. Strong experience in Cybersecurity and IT Controls, with significant experience

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