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Position Summary: As the Associate Director, US Brand Marketing, you will serve as a strategic leader and brand ambassador for one of our key vaccines within our influenza vaccines portfolio. Reporting to the Director, US Brand Marketing, you will be responsible for developing and executing brand strategies that differentiate our offerings in a highly competitive and rapidly evolving market. You will collaborate cross-functionally to drive brand growth, enhance market positioning, and ensure alignment with commercial objectives across the U.S. market. Key Responsibilities: Brand Strategy & Execution • Lead the development and execution of the annual brand plan, including strategic imperatives, key initiatives, and tactical execution for the brand with oversight from the Director of Brand Marketing., • Develop compelling brand messaging and promotional campaigns that resonate with key stakeholders in the vaccine decision-making process and align with specific market/customer needs., • Support the holistic commercial offer by integrating clinical, operational, and financial value propositions into brand promotional messaging/tactics., • Oversee agency management, MLR review, and budget management for the brand's promotional activities., • Identify and monitor metrics to assess performance and execution of promotional activities. Cross-Functional Leadership • Collaborate with Sales, CE, Market Access, Customer Ops, Medical Affairs, Regulatory, Legal, Policy, and Communications to ensure cohesive execution of brand strategies., • Serve as the brand champion across internal and external stakeholders, including advocacy groups and professional societies. Market Insights & Competitive Intelligence • Conduct and synthesize primary and secondary market research to inform brand decisions., • Monitor competitor activities and market dynamics to proactively adjust strategies. Sales Enablement & Training • Partner with Sales and Training teams to develop tools and resources that support field execution., • Support workshops and assessments to ensure message mastery and alignment with commercial goals. Minimum Requirements: • Bachelors' degree required, preferably in Life Sciences or Business/Marketing. MBA is preferred., • Minimum 8+ years' healthcare experience with 5+ years' commercial marketing experience in pharmaceutical/ biotech or relevant industry;, • Vaccines or buy and bill product experience preferred, • Experience in a range of sales, marketing, sales training and commercial roles in the life sciences businesses, • Pharmaceutical/biotech/medical device sales experience is advantageous, • Some domestic travel required (e.g. sales meetings, field rides, conventions) The expected base salary range for this position at hiring is $180,000 - $205,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity. #LI-Hybrid CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals. Please take the time to review our ___ to see what’s available to you as a CSL Seqirus employee. ___ is part of ___. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more ___. Watch our ‘On the Front Line’ video to learn more about CSL Seqirus

Job Description Job Summary: The EVP, Scientific Affairs oversees the operations of the Quality Assurance and Quality Control Departments for all divisions across multiple locations and has overall responsibility for the technical operations and the strategic planning of adequate resources needed to ensure the required quality of laboratory operations meet business requirements and customer deliverables. They will develop, implement, and periodically evaluate the QC/QA Department activities to ensure the organization’s production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization to meet the requirements of customers, consumers, and regulatory and accrediting agencies. The role is also responsible for ensuring cGMP compliance across all business divisions within the Company. The EVP, Scientific Affairs will be accountable for the timely release of products at all steps of the Manufacturing process, based on justifiable rationale, valid scientific data, process control items, etc. Principle Responsibilities: • Directs all Scientific Affairs and assumes responsibility for all Quality related matters; sets priorities and oversees the daily efforts of the QC/QA Team., • Provides guidance and works with various Departments in maintaining cGMP compliance within all business divisions of the Company., • Initiates Quality processes that drive continual improvement within the organization., • Conducts internal quality control audits and random inspections of each site’s Quality Management System as required and periodically reports on status of quality control and operations to executive leadership and, when required, regulatory agencies., • Provides support for third party cGMP certification audits and ensures appropriate corrective actions are conducted., • Directly involved with on-site regulatory (FDA, NJ-DHHS, etc.) inspections as well as internal and third-party audits and writing and overseeing responses to audits to comply with cGMP and GLP. Serves as the contact person and co-hosts any regulatory agency audits and inspections and provides guidance in responding to any regulatory agency questions or observations., • Facilitates communication among production divisions and management. Provides support to Manufacturing and Product Development as required to troubleshoot production problems and collaborates with management and senior staff across production departments and roles to draft acceptable quality standards., • Evaluates internal and external laboratory capabilities. Recommends new testing procedures and equipment to support cGMP and customer specific requirements., • Develops and implement standards, methods, and procedures for inspection and testing, validation of systems and analytical processes, documentation, and change control systems that ensure the identity, purity, strength, and composition of ingredients and finished products are to specifications., • Evaluates production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements and monitor the compliance through robust internal audit program., • Ensures all laboratory controls and functions and all Quality Control functions as designated in 21 CFR GMP Part 110, 111 and 117 are in place, documented, monitored and enforced to maintain the QC Lab within a cGLP environment at all times., • Assess test results and approve recommended changes., • Review quality control documentation such as checklists, logs, and reports for effectiveness, accuracy, and relevance., • Select, upkeep, calibrate, recertify, and document all instrumentation in the QC lab., • Oversee lot release of components, raw materials, and finished products., • Develop raw material specifications and finished product specifications once material has been through the Product Development process and route for signature., • Ensure sampling and testing priorities are consistent with Manufacturing, Production, and Customer Service schedules., • Preparation of analytical documentation (OOS, deviation reports, test methods, change controls, Certificate of Analysis) for incoming raw materials and finished goods., • Review technical control documentation (SOPs, Batch Records, test methods, specifications, COAs, etc.) from a Quality and Compliance perspective; ensure continuous improvement of departmental SOPs to stay up to date with regulatory and compliance guidelines; create, revise, and gain approval to implement lab SOPs and procedures and to review qualification documents for laboratory instrument/software as is necessary., • Maintain and improve department performance to meet requirements of Regulatory Authorities as well as the policies and standard procedures of the company., • Ensure that all systems, laboratory controls, procedures and instructions are described adequately to enable assurance of quality of the test results generated in the QC laboratories., • Provide technical guidance for validation of analytical methods and develop overall strategy to manage all critical reagents, reference standard, and reference control materials used in the laboratory., • Establish proper communication channels to manage, mentor direct reports to higher levels of management capability and provide strategic leadership to further strengthen the platform with a highly functional QC team., • Plan strategically/proactively with management of other platforms to ensure that resources are allocated adequately to meet each program’s needs., • Ensure that QC decisions are aligned with governance from Company Procedures and regulatory requirements., • Coordinate management structure of the laboratory to build Analytical datasets (release, and analytical verification) for Starting materials, In Process and Finished goods., • Identify gaps and assist with annual budget at both CAPEX and Operation levels. Direct – AVP, VP or Director of QC, QC/QA Team Indirect – Production Staff Supervisory Responsibilities: • Directs and oversees the quality control and quality assurance departments and supervisory staff., • Train QC/QA Team as necessary and validate their work periodically., • Perform annual performance reviews that are timely and productive and develop training plans with direct reports., • Handle discipline and termination of employees in accordance with company policy., • Ensure staff are provided with corporate communications. To perform this job successfully, an individual must be able to perform each principal responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Education: BS degree in Chemistry, Engineering or Life Sciences required. Advanced degree preferred. Experience: 10 years in the manufacturing QC/QA field with a minimum of 5 years supervisory experience directing QC/QA and Documentation function within the Nutraceutical or Dietary Supplements industry is required. Solid overall knowledge of USP, FCC, and FDA guidelines as applied to testing of cosmetic and dietary supplement ingredients and finished goods. Experience leading FDA inspections is highly desirable. The desirable candidate will also be knowledgeable in analytical instrumentation (i.e., HPLC, GC, UV-Vis, FT-IR, Atomic Absorption, TLC and USP dissolution apparatus 1 and 2). Working knowledge of product stability studies and microbiological analysis of raw materials, in-process and finished goods required. Physical Requirements: Work requires ability to lift up to 25 pounds; sitting, standing, walking, bending and/or stooping for periods of five hours or more; moving and examining objects at high and low reach, and reading for periods of three hours or more; prolonged periods working on a computer. Position requires normal visual acuity. Additional Skills and Qualifications: Proven experience managing technical services and staff. Demonstrated knowledge of current cGMP requirements, regulations and standards to ensure the maintenance of the cGMP standard of quality. Thorough understanding of quality control standards and methodologies. Thorough understanding of manufacturing and production in the industry. Ability to read and interpret documents such as safety rules, operating and maintenance work instructions, procedure manuals and SDS sheets. Must have the ability to communicate effectively orally and in written form. Must be able to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and decimals. Must understand and use advanced statistical methods. Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Must have ability to solve complex problems involving multiple variables in standardized situations. Must have a deliberate and acute sense of documentation of all activities while in the manufacturing environment. Must be proficient with and be able to communicate via e-mail. Must be proficient with and able to use computer software including word processors & spreadsheets (Microsoft Word, Excel, Access), and ERP System. Proficient in oral and written communication skills. Must be able to communicate effectively in a cross functional team environment to complete work tasks as instructed. Must have sound judgment and decision-making skills. Excellent organizational skills and demonstrated attention to detail and thoroughness are critical. Strong analytical and problem-solving skills. Strong supervisory and leadership skills. Vital Health America is an Equal Opportunity Employer Company DescriptionVital Health America is committed to manufacturing nutraceutical products of the best quality and features by adopting innovation in design and technology with the end target in mind. We can offer our clients a wide range of standard formulas to choose from or they can design their own unique supplement line. Our scale-up and industrialization experience means that the finished product is ready for large-scale production and commercialization, saving our clients both time and money.Vital Health America is committed to manufacturing nutraceutical products of the best quality and features by adopting innovation in design and technology with the end target in mind. We can offer our clients a wide range of standard formulas to choose from or they can design their own unique supplement line. Our scale-up and industrialization experience means that the finished product is ready for large-scale production and commercialization, saving our clients both time and money.

Job Description Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world. About the Role The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-approval changes), supporting commercial product lifecycle management, and providing backup to the Director of Regulatory Affairs. The role plays an essential part in ensuring timely, compliant regulatory filings and strategic input for product development, with particular focus on complex generics and combination products. This role also includes supporting GDUFA III-related meeting package preparation. Responsibilities • Compile and submit ANDAs, supplements (CBE/PAS), annual reports, and labeling supplements in compliance with FDA requirements., • Author relevant eCTD sections using company templates and ensure files are properly formatted with bookmarks, hyperlinks, and metadata., • Evaluate proposed product and process changes against current FDA guidance and industry standards. Recommend appropriate filing strategies, timelines, and risk-based approaches for submission planning and execution., • Support regulatory strategy and submissions for complex generics and combination products (e.g., transdermal systems, injectables, drug-device combinations)., • Create and maintain internal templates, trackers, and tools to manage regulatory planning and combination product submissions., • Provide regulatory support for Design History Files (DHFs), ensuring consistency and alignment with FDA expectations for device related documentation., • Prepare formal meeting packages and briefing documents under GDUFA III, including pre-submission and mid-cycle meetings., • Coordinate with internal departments and external partners for documentation collection, timeline management, and regulatory compliance., • Represent Regulatory Affairs in internal cross-functional meetings and external partner calls, as needed., • Lead regulatory activities for post-approval changes including site transfers, analytical method updates, container/closure system changes, and alternative sourcing of materials., • Participate in product development from early-stage formulation to final submission, incorporating FDA feedback and seeking regulatory guidance when appropriate., • Draft, review, and maintain product labeling and promotional labeling, ensuring alignment with current regulations and internal policies., • Review technical documentation and provide regulatory guidance to internal and external stakeholders. Ensure all submissions meet FDA standards, cGMP requirements, and Quality-by-Design (QbD) principles., • Ensure submission documentation is accurate, complete, and in compliance with applicable FDA regulations and company quality standards. Qualifications • Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field required., • Advanced degree preferred. Required Skills • 5+ years’ experience in pharmaceutical regulatory affairs., • Experience with complex and combination products and knowledge of FDA expectations., • Experience with eCTD software, MSWord, Excel, Adobe Acrobat and other document processing software., • Independently compiled and filed ANDAs, • Familiar with cGMP requirements., • Sterile products experience Compensation & Benefits At Breckenridge Pharmaceutical, Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location: • Flexible approach to how we work, • Health benefits and time-off programs, • Competitive compensation packages, • The anticipated annual salary for this role is $88,000-125,000 Equal Opportunity Statement Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job Description ABOUT ORGANOX: OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally. Position Summary The position of Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g. INDs, IDEs and PMAs) for North America as well as assisting in the implementation of the company’s quality goals and objectives. Other responsibilities include assisting with compliance activities related to ISO, GMP and applicable medical device standards. This role will report directly to the Director of Regulatory Affairs and collaborate with other team members within the regulatory department as needed. Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the person will be expected to complete tasks reasonably requested by the Director of Regulatory Affairs. This is a flexible on-site position in Madison, NJ and may require up to 5% travel domestically or internationally. Major Responsibilities Under direction from the Director of Regulatory Affairs, the Senior Regulatory Affairs Specialist will be responsible for: · Providing regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Combination products and other new venture initiatives. · Supporting pre-market and post-market regulatory activities for assigned projects. · Collaborating with cross-functional teams to provide regulatory support. · Preparing regulatory submissions (IDE; IDE Supplements; PMA; PMA Supplements, etc.) for submission to the FDA and Health Canada. · Interfacing with the FDA and Health Canada on assigned projects. · Responding to FDA and Health Canada requests for additional information. · Keeping abreast of changes to US and Canada regulatory requirements and International Standards related to OrganOx products and processes. · Formally communicating regulatory initiatives or changes in the applicable medical device law with company personnel, customers, subcontractors, regulatory agency representatives, and third-party organizations. · Perform regulatory change assessments as required. · Reviewing applicable regulatory guidance and standards for assigned projects to ensure compliance with regulations and determining regulatory impact. · Prepare visualizations and conclusions for presentation to upper management. · Working with key stakeholders in relation to Regulatory topics. · Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies. Requirements · Skills and Experience · Working knowledge of FDA processes for medical device compliance. · Experience with Software as a Medical Device (SaMD), Cybersecurity and Combination products is preferred. · Experience with Class II and Class III devices. · The ability to write clear regulatory strategies and submissions. · A good understanding of GMP compliance requirements in Quality Control. · Experience in cross-functional collaboration with Manufacturing, Quality, R&D, Clinical and Marketing departments. · Computer proficiency in MS Office (i.e., Word, Excel, PowerPoint) · Excellent verbal and technical writing skills. · Ability to work independently. Qualifications The Senior Regulatory Affairs Specialist will have: · A minimum of a Bachelor’s degree in engineering, life sciences, or other related area · A minimum of 3-8 years of related regulatory experience (depending on education level) with Class II/III medical devices · Regulatory Affairs Certification (RAC) (Optional) · Ability to travel 5% of the time domestically or internationally. Applicants must be authorized to work in the U.S. without sponsorship. OrganOx is not offering relocation assistance for this role. #LI-Onsite A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate. Benefits The Pay Range for this position is $115,000 - $140,000 annually, with a 10% target annual bonus and benefits. At OrganOx, we offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Job Description Position Summary: Oncology Avyxa Pharma, a leading manufacturer of 505(b)(2) oncology products, is seeking an experienced and driven Director of Sales to lead our sales efforts in the eastern and western United States. These individuals will be responsible for managing a team of sales professionals, driving business growth, and developing strategic relationships with key stakeholders in the oncology space while maintaining a competitive and positive work culture. The ideal candidate will have pharmaceutical sales experience, with a strong background in oncology and 505(b)(2) drug commercialization. This role requires up to 70% travel and reports to the Vice President of Sales & Corporate Accounts. Key Responsibilities: · Following company strategic goals and philosophy, the Director of Sales will provide sales leadership and guide strategic direction for direct reports in assigned territory. · Lead and mentor a team of sales professionals, setting performance objectives and ensuring successful execution as evidenced by quarterly goal attainment for all qualified Avyxa products. · Will work independently and with direct reports to identify and develop new business opportunities to drive market penetration and revenue growth endeavoring to maintain strong customer relationships over an extended period. • Team Management & Development:, • Recruit, train, and develop a high-performing sales team that will have responsibility for selling Avyxa’s products including but not limited to Docivyx®, Frindovyx™, Posfrea™ and Axtle™., • Conduct regular performance reviews, provide coaching, and support career development., • Foster a collaborative, results-driven culture within the sales organization., • Customer Engagement & Relationship Management:, • Build and maintain strong relationships with customers, including but not limited to oncologists, pharmacists, nurses, key business personnel, aggregator and group purchasing organizations (GPOs) sales representatives., • Work closely with direct reports to ensure customer needs are met and growth opportunities are maximized by maintaining close relationships with customers, providing Avyxa product contract updates, Avyxa support materials, and ensuring productive collaboration between customers and other internal Avyxa resources (market access, field reimbursement, payer team, operations) • Represent Avyxa Pharma at industry conferences, advisory boards, and networking events. Data-Driven Decision Making: • Utilize Tableau, Excel, and other analytics tools to track sales performance and market trends., • Prepare and present sales reports, forecasts, and business reviews for senior leadership., • Communicate and leverage market intelligence to adjust strategies and optimize sales efforts., • Cross-Functional Collaboration:, • Partner with Avyxa Strategic Account Directors, Data and Analytics, Field Reimbursement Team, Operations Team, and Medical Affairs to ensure effective product positioning and messaging., • Provide customer insights to support product development and commercialization efforts., • Ensure compliance with pharmaceutical regulations and corporate policies. Qualifications & Experience: • 8+years of pharmaceutical sales experience, with at least 3 years in oncology. Managerial experience preferred. Candidates with similar experience and exceptional track record of success will be considered., • Strong understanding of the 505(b)(2) regulatory pathway and drug commercialization in community oncology and hospital/IDN setting preferred., • Proven leadership experience with a track record of managing and developing sales teams., • Excellent verbal and written communication skills., • High proficiency in PowerPoint, Excel, Tableau, and other sales analytics tools., • Ability to travel up to 70% across the designated region. Preferred Qualifications: • Experience working with community oncology practices, hospitals, and integrated delivery networks (IDNs)., • Sales management · Understanding of the buy-and-bill oncology reimbursement methodology, GPO and aggregator relationships. • Prior experience launching 505(b)(2) oncology drugs. Location: Remote (Must reside within the designated region) Compensation & Benefits: Competitive salary, performance-based bonus, comprehensive benefits package, and travel reimbursement. Company DescriptionAvyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system. Our core values are grounded in providing access to meaningful products that improve patient care.Avyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system.\r\n\r\nOur core values are grounded in providing access to meaningful products that improve patient care.

Job Description THE COMPANY The Low Income Investment Fund is a non-profit Community Development Financial Institution (CDFI) that mobilizes capital and partners to achieve opportunity, equity and wellbeing for people and communities. LIIF innovates financial solutions to create more equitable outcomes for all by building and preserving affordable homes, quality educational opportunities from early childhood through higher education, health clinics, healthy food retail and community facilities. In this way, LIIF provides a bridge between private capital markets and communities. LIIF’s headquarters is in San Francisco and has offices in Los Angeles, New York, Atlanta, and Washington D.C. REPORTING RELATIONSHIPS: This position reports to the Director, National Community Facilities Lending. JOB SUMMARY: The Deputy Director serves as a senior member of the National Community Facilities Lending team, supporting the Director in achieving lending targets, managing te*/am performance, and ensuring strategic alignment across lending programs. This role combines leadership in loan production with oversight of special initiatives, portfolio quality, policy integration, and product innovation. The Deputy Director works collaboratively across departments to deliver high-impact lending solutions for under-resourced communities and serves as a public-facing representative of LIIF’s thought leadership in the sector. KEY RESPONSIBILITIES: Strategic Lending Oversight – 30% • Lead oversight of the full loan lifecycle for community facility transactions, ensuring quality, timeliness, and alignment with LIIF’s lending strategy., • Set performance expectations and monitor progress toward lending targets across the national community facilities portfolio., • Troubleshoot complex or stalled transactions and advise Loan Officers on deal structuring, regulatory issues, or partnership alignment., • Ensure adherence to credit policies, impact guidelines, and risk thresholds by reviewing loan memos, financial models, and credit packages., • Serve as a direct supervisor to Senior Loan Officers and other team members, providing coaching, regular performance feedback, and career development planning., • Design and deliver onboarding and continuing education opportunities for lending staff, including credit analysis, market intelligence, and federal program training., • Foster a high-performing team culture that values accountability, collaboration, learning, and racial equity., • Manage relationships with major borrowers, anchor institutions, foundations, and public sector agencies., • Represent LIIF in high-stakes negotiations, coalition efforts, and capital roundtables to secure pipeline opportunities., • Ensure strong coordination between Lending and the Communications, Development, and Policy teams on fundraising or co-marketing efforts., • Oversee implementation of federal, state, and philanthropic capital programs, including ensuring compliance with eligibility and reporting requirements., • Work in partnership with the Director of Federal Policy and Government Affairs to align lending programs with emerging policy opportunities., • Lead product development efforts in response to new capital tools, unmet market needs, or borrower demand (e.g., for predevelopment or working capital loans)., • Collaborate with the Director, Credit Officers, and Asset Management to maintain portfolio health, address early warning signs, and manage distressed assets., • Provide input into loan pricing, underwriting standards, and risk rating criteria based on real-time market data., • Represent LIIF as a senior thought leader in the community development finance sector., • Represent LIIF at national conferences and industry forums through participation in panels, publication of articles or case studies, and by fostering relationships with peer CDFIs, funders, and investors to elevate the organization’s visibility and thought leadership., • Maintain strategic relationships with external collaborators in real estate, education, health, and financial services., • Participate in strategic planning efforts and annual budget forecasting., • Support cross-functional projects, DEI initiatives, or impact reporting development., • Provide input to executive leadership on organizational priorities, emerging challenges, or special initiatives. QUALIFICATIONS: • Bachelor’s degree in Finance, Business, Public Administration, Real Estate, or a related field. Advanced degree preferred., • 8–10 years of progressively responsible experience in community development lending, with a focus on real estate-based transactions., • Proven expertise in loan origination, underwriting, deal structuring, and risk mitigation., • Strong experience with charter school, early learning, health facility, or community facility financing., • Demonstrated success managing lending teams and mentoring junior staff., • Advanced financial analysis skills, particularly in nonprofit and real estate financials., • Deep knowledge of CDFI industry standards, NMTCs, and public subsidy layering., • Familiarity with federal, state, and local funding sources for housing and community development., • Strong strategic planning, time-management, and organizational skills., • Excellent interpersonal, oral, and written communication skills., • Track record of building and maintaining relationships with borrowers, partners, and public agencies., • Proficiency with Microsoft Office Suite and financial or CRM database systems., • Self-motivated, mission-aligned, and committed to equity in underserved communities. ADDITIONAL INFORMATION: LIIF offers a hybrid work environment with flexibility to balance in-office and remote work. However, all employees are expected to work on-site at least two (2) days per week. The successful candidate may be expected to travel occasionally for meetings, trainings, conferences, or other Company sponsored events. All Low Income Investment Fund (LIIF) employees must be fully vaccinated against COVID-19. In accordance with LIIF's policies, we provide reasonable accommodations, absent undue hardship, to qualified individuals who cannot get vaccinated against COVID-19 because of sincerely held religious or medical reasons. If you believe you need an accommodation from the vaccination mandate required by this policy, please notify our Human Resources Department. HOW TO APPLY: Please apply with Resume and Cover Letter via our recruitment portal: Recruitment (adp.com) Notice to Third Party Recruitment Agencies: Please note that Low Income Investment Fund does not accept unsolicited resumes from recruiters or employment agencies. In the absence of an executed Recruitment Services Agreement, there will be no obligation to any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without an agreement Low Income Investment Fund shall explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, shall be deemed the property of Low Income Investment Fund. We do not accept unsolicited phone calls. Only candidates being considered for a position will be contacted. LIIF, an EOE (Equal Opportunity Employer), believes that diversity ensures excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender, or national origin. Candidates of diverse backgrounds and with diverse experience are strongly encouraged to apply for this position.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways. Job Overview: The Senior Manager, Regulatory Affairs will be a strategic thinker, responsible for researching and assessing regulatory precedence and contributing to regulatory strategies for development of Compass Pathways investigational drug programs. As assigned, this individual will be responsible for application maintenance activities, amendments, supplements, regulatory intelligence activities, and other policies and procedures. This position assists in maintaining organization's Regulatory Affairs operational functions and direct lines of communication for, interactions with, and access to Regulatory Authorities/Agencies in the US and abroad, in compliance with regulatory guidance, regulation and laws. This position is a generalist role and will be part of a regulatory team. The individual will have collaborative and leadership skills to allow for successful cross functional interactions with the organization. Location: Remote on the East Coast in the United States or hybrid in our New York City office. Reports to: Senior Director, Regulatory Affairs Roles and Responsibilities: (includes but are not limited to) • Supports the execution of regulatory strategies and implementation plans for the preparation and submission of investigational and new drug applications, amendments, investigator filings, annual reports, and associated labelling, • Manages assigned regulatory communications and assists with preparation activities for Agency meetings, responses to Agency requests, and pre-meeting packages to ensure the organization complies with applicable regulation and guidance, • Manages regulatory intelligence process – monitors for new or changing regulations and coordinates internal stakeholders to ensure development of strategies to address applicable changes, • Supports management of regulatory applications to ensure compliance with regulations, including tracking of submission timelines, coordination of authoring and review of submission deliverables, and proactive identification and communication of delays and risks, • Acts as a regulatory representative on assigned project teams, providing regulatory guidance and recommendations in line with company goals, applicable laws and regulations, and the overall regulatory strategy, • Liaises with the Regulatory Operations team to coordinate publishing activities and timelines for assigned submissions, • Conducts regulatory research in relation to assigned programs and disseminates relevant information to management and cross-functional teams, • Considerable regulatory experience in a CRO/biotech/pharmaceutical company, • BSc degree in relevant/related discipline/industry required, advanced degree a plus, • Experience in CNS/psychiatric therapeutic area a plus, • Extensive experience with Microsoft Word and PowerPoint, Adobe Acrobat; familiarity with SharePoint, ISI Writer and/or similar common pharma/biotech industry applicable platforms; Microsoft Project experience a plus, • Experience in interpretation of regulations, guidelines, policy statements, etc, • Experience and knowledge in the preparation of regulatory submissions, including amendments or supplements, • Strong attention to detail and the ability to manage multiple tasks, • Collaborative attitude and willingness to work in a cross-cultural environment, • Ability to work in a fast pace and dynamic atmosphere, • Adaptive thinking and "can-do" spirit, • Strong team player and communicator - proactive planner and solutions oriented, • Ability to work both independently with minimal supervision and within a matrix management structure Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$166,000—$215,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Position Overview As Director of Federal & Integrated Regulatory Guidance, you will manage a team of regulatory professionals who analyze new regulatory requirements, work closely with the business to understand the impact and obligations of those requirements, and support the business in understanding the evolving regulatory landscape. With wide latitude for individual initiative and decision making, the position is responsible for providing leadership and oversight relating to all Federal & Integrated products offered by client. This role primarily operates remotely with in-office presence only as needed for key meetings, collaboration, or business needs. Job Description • Provide leadership and expertise in analysis and interpretation of complex and voluminous enacted state laws across the client portfolio of Federal and Integrated products. These consist of Managed Long-Term Care (MLTC), Medicaid Advantage Plus (MAP), Medicare Advantage, and Medicare D-SNP., • Direct and supervise the Regulatory guidance team to ensure that all new regulations and product contract updates, and final rules are disseminated throughout the organization., • Provide regulatory support to the organization, including providing regulatory interpretation and gaining clarification from regulatory bodies., • Proactively communicate with internal divisions to become and remain educated about key regulatory issues affecting these areas., • Support continuous improvement of communication processes to better inform the enterprise of new legislation and regulatory agency directives., • Develop and maintain relationships with regulatory agencies and stay up-to-date on any changes or updates to regulations., • Participate in stakeholder calls and create summaries of calls for dissemination to senior staff., • Work with the Regulatory Operations team to support the preparation and submission of regulatory filings, reports, and documentation., • Identify and assess potential regulatory risks and develop strategies to mitigate those risks., • Collaborate with cross-functional teams to ensure compliance across all areas of the organization., • Participate in high-level implementations of carve-in/carve-out services; program services such as changing vendors or adding new vendors., • Assist the Compliance teams with understanding of Federal, State and Local regulations and product contract requirements., • Partner with Compliance team on management of and response to external audits and surveys, including CMS Program Audits., • Participate in engagement with Local and State agencies and Trade Associations., • Demonstrate strategic mindset to deliver value to business teams., • Support and coordinate with business leaders on regulatory changes to drive achievement of business goals and clarity of regulator expectations., • Anticipate policy and emerging regulatory trends and coordinate advocacy strategies with government relations team., • Cultivate and maintain solid collaborative relationships with business clients, regulators and client business partners., • Supervise a team of Regulatory Analyst staff assigning tasks and projects and conducting performance evaluations., • Ensure that the team is adequately trained and equipped to perform their duties, including identifying and addressing knowledge and skill gaps and that staff are up to date with work assignments and provide guidance as needed., • Provide feedback to staff to help improve their productivity, efficiencies and growth. Minimum Qualifications • Bachelor's degree, • Minimum seven (7) years of experience working with Medicare and Medicaid laws/regulations, including having held a senior position, in a managed care compliance or regulatory department and must possess detailed knowledge of the rules governing managed care health plans., • Thorough knowledge in the application of health law and policy, managed regulation and compliance programs and/or the fundamentals of healthcare organization, administration and standards, regulations and law applicable to health plan operations., • Knowledge of business and human resources administration principles, management functions, management processes and functions of health plan departments., • Ability to direct and supervise personnel., • Collaboration and Demonstrable strategic thinking ability, • Management of multiple projects simultaneously to own workload, • Excellent oral, written, and presentation skills, as well as conceptual and analytic skills are necessary in order to review and articulate corporate objectives and Federal regulations across all relevant audiences., • Integrity and Confidentiality, • Experience with legal research applications (such as Lexis)., • Ability to effectively understand and communicate detailed and complex information verbally and written with others. Solid verbal and written communication skills.

Job Description About Westman Atelier A new standard of clean luxury. Founded by world-renowned editorial makeup artist Gucci Westman, Westman Atelier is a curated edit of skin-loving, performance-first makeup that is always effortless, never overdone. A mother, makeup artist, and champion of holistic living, Gucci believes passionately that ‘luxury’, ‘efficacy’ and ‘clean’ can be synonymous with exceptional makeup. • A skincare approach to high performance make-up formulated with clean ingredients and no-compromise integrity Gucci Westman has more than 20 years of professional experience as a major editorial makeup artist, contributing to publications like Vogue and Harper’s Bazaar. Gucci is known for creating dewy, supernaturally glowy looks and her highly coveted “second-skin approach” to makeup, resulting in naturally beautiful, radiantly amplified skin. Position Summary The Director, Product Development will play a pivotal role in driving innovation and ensuring the successful development of high-quality, sustainable, and ethically sourced products aligned with our brand and founder ethos. Reporting to the VP, Product Development & R&D, you will lead a team of talented professionals and collaborate closely with immediate and cross-functional teams to bring new products to market, consistently upholding our brand's commitment to clean beauty standards. Responsibilities: • Develop and execute a strategic product development roadmap that aligns with the brand's clean beauty ethos, market trends, and identifies opportunities for innovation and expansion within the clean beauty space., • Manage the entire product development lifecycle from concept through launch, including defining timelines, setting milestones, and allocating budget to ensure on-time delivery of new product launches., • Bring deep expertise in building and expanding shade ranges across all product categories, ensuring they are diverse, relevant, market-competitive, and aligned with Gucci’s creative vision and brand values., • Collaborate closely with the VP of PD + R&D and Regulatory Affairs Manager to oversee the formulation process from initial concept briefing to final launch, ensuring all products meet stringent clean beauty standards, regulatory requirements, and performance expectations., • Brief labs on new projects across all makeup and skincare categories, lead weekly lab calls, and ensure continuous follow-through on product lifecycle with external partners and internal teams., • Oversee and support the approval and meticulous tracking of pre-production samples for all open product orders, ensuring consistency and quality., • Rigorously manage timelines for formula development, shade matching, and all required testing phases in collaboration with the team., • Collaborate with the team to proactively identify, troubleshoot, and resolve any challenges that arise throughout the product development cycle., • Assist directly in all innovation initiatives alongside the founder., • Bachelor's or Master's degree in Product Development, Cosmetics Science, or a related field., • Proven experience (8-10 years) in product development within the beauty or cosmetics industry, with a strong, demonstrated focus on clean beauty products., • Deep understanding of clean beauty principles, ingredient sourcing, formulation techniques, and global regulatory requirements., • Impeccable attention to detail and a commitment to product excellence., • Strong leadership and team management skills, with a track record of building, mentoring, and developing high-performing teams., • Excellent project management abilities, including the capacity to prioritize tasks, meet aggressive deadlines, and manage multiple complex projects simultaneously., • Exceptional communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams, external partners, and senior leadership., • A genuine passion for sustainability, ethical sourcing, and advancing the principles of clean beauty.Westman Atelier offers a holistic total compensation package designed to support employees in all aspects of life, including a robust suite of health benefits, wellness perks, 401k, and paid parental leave. The base salary for this position will range from $140,000-180,000. Exact compensation may vary based on job related skills, experience, and location. Powered by JazzHR aTf3E42jby

Job Description As a Senior Director of Regulatory Affairs, you will manage a team of regulatory professionals who analyze new regulatory requirements, work closely with the business to understand the impact and obligations of those requirements, and support the business in understanding the evolving regulatory landscape. With wide latitude for individual initiative and decision making, the Senior Director of Regulatory Affairs is responsible for providing leadership and oversight of the Regulatory Affairs unit relating to all products offered by Health, as well as leading other projects assigned by Executive Leadership. • Provide leadership and expertise in analysis and interpretation of complex and voluminous enacted laws (state and federal) across the portfolio of businesses., • Direct and supervise the Regulatory Affairs unit to ensure that all new regulations and product contract updates are disseminated throughout the organization., • Provide regulatory support to the organization, including providing regulatory interpretation and gaining clarification from regulatory bodies. Proactively communicate with internal divisions to become and remain educated about key regulatory issues affecting these areas., • Lead continuous improvement of communication processes to better inform the enterprise of new legislation and regulatory agency directives., • Assist the Compliance teams with understanding of Federal, State and Local regulations and product contract requirements., • Establish protocols and guidelines for oversight of implementations of new rules/requirements, including carve-ins of services and populations to various insurance products., • Develop and advise on comprehensive and actionable communications and content informing of regulatory analysis, changes, and impact, to facilitate stronger front-end compliance consistent with regulations., • Partner with Compliance team on management of and response to external audits and surveys relating to NY State product offerings, including NYS Department of Health Article 44 program audits., • Participate in engagement with Local, State, and Federal agencies, and Trade Associations., • Oversee and manage workflows to ensure timely and appropriate resolution of Regulatory Complaints and Fair Hearings., • Serve as leadership interface with internal departments (including sales, operations, product, pharmacy, communications, government affairs, legal) and external clients relating to regulatory matters., • Demonstrate strategic mindset to deliver value to business teams., • Support and coordinate with business leaders on regulatory changes to drive achievement of business goals and clarity of regulator expectations., • Anticipate policy and emerging regulatory trends and coordinate advocacy strategies with government relations team., • Cultivate and maintain solid collaborative relationships with business clients, regulators and business partners., • Bachelor's degree required, • Minimum ten years of experience working with Medicare and Medicaid laws/regulations, including having held a senior position, in a managed care compliance or regulatory department and must possess detailed knowledge of the rules governing managed care health plans., • Thorough knowledge in the application of health law and policy, managed regulation and compliance programs and/or the fundamentals of healthcare organization, administration and standards, regulations and law applicable to health plan operations., • Knowledge of business and human resources administration principles, management functions, management processes and functions of health plan departments., • Ability to direct and supervise personnel., • Experience building relationships across business groups internally and outside the organization

Job Description About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. Position Overview The Vice President (VP), Clinical Development is a leadership role responsible for guiding Tonix Pharmaceuticals' clinical development programs. Reporting directly into the Chief Medical Officer (CMO), this position will provide strategic oversight to ensure excellence in clinical research, regulatory interactions, and product approvals within Tonix's core therapeutic areas including central nervous system (CNS) disorders, Transplant, Immunology and Oncology. Essential Duties • Define and lead the company’s clinical development strategy, ensuring alignment with corporate vision and regulatory expectations with Tonix’s pipeline and therapeutic focus., • Oversee the planning, design, execution, and completion of clinical trials (Phases I-IV), ensuring efficiency, scientific rigor, and compliance with regulatory standards, timelines, and budgets. Oversee the development of clinical protocols, investigator brochures, statistical analysis plans, and other critical regulatory documents. Collaborate with clinical operations to ensure the quality and integrity of clinical data; and support scientific communications and publications regarding pipeline programs. Maintain a strong focus on innovation in clinical trial design, patient-centric approaches, and biomarker-driven strategies., • Oversee the selection and management of CROs, academic partnerships, and external collaborations to optimize clinical trial execution., • Drive a culture of operational excellence, regulatory compliance, quality assurance, adherence to GCP guidelines, ethical considerations, and scientific integrity across Clinical Development., • Represent the company at key scientific conferences, industry consortia, and investor presentations to enhance corporate reputation., • Provide leadership to the Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams., • Provide medical and scientific leadership to cross-functional teams, integrating insights from medical affairs, regulatory affairs, and commercial teams to drive program success., • Partner with R&D, Medical Affairs, Commercial, and Business Development teams to align clinical development with broader corporate objectives., • Serve as the clinical development leader for assigned pipeline programs in interactions with global regulatory agencies (FDA, EMA, etc.), ensuring effective engagement, submission strategies, and post-approval commitments; lead the preparation and review of regulatory submissions, including INDs, NDAs, BLAs, and CTAs., • Cultivate and maintain strong relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations specific to the products and indications for the programs led., • Build, mentor, and lead high-performing teams, fostering a culture of excellence, innovation, and accountability., • Strong ability to build and sustain meaningful relationships with KOLs, regulatory bodies, and external strategic partners., • Exceptional leadership, mentorship, strategic planning, and operational management skills., • MD or DO, expertise and experience in rheumatology or immuno-oncology strongly preferred., • Experience: 10-15 years of relevant experience, demonstrating progressive leadership in clinical development within pharmaceutical or biotechnology companies, including prior experience serving at the Senior Director level or above in Clinical Development organizations., • Demonstrated success in leading clinical development programs., • Regulatory Compliance: Extensive experience with regulatory interactions, submissions, and product approvals. Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $250,000 to $350,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

Job Description About the Job The primary function of this position is to oversee a full portfolio of approved and unapproved ANDA products. The incumbent might also be designated as U.S. Agent (back-up) for the U.S. Office for both ANDAs (GPI USA) and API (GLS India). The position includes a number of responsibilities that will require excellent communication to support both internal and external customers (globally) including the U.S. FDA. Job Responsibilities Note: These statements are not intended to be an exhaustive list of all responsibilities and duties. • Manage at least one (1) and possibly up to (2) direct reports to ensure their assigned responsibilities are completed accurately and on a timely basis to support the needs of the business for internal/external customers., • Support the U.S. Office for more than 170 approved ANDAs and all unapproved (under review ANDAs) as U.S. Agent back-up for all Glenmark subsidiaries including GPL, GSSA, GPI and GLS. The successful candidate will need to be able to review and sign various submissions to FDA. It will include ANDA cover letter, Form 356H for Original ANDAs, Amendments to ANDAs and/or Supplements to post-approval work. Form 2252 for Annual Reports., • Provide support/RA strategy needed to achieve timely approvals with the Agency., • Update the internal tracker that records all incoming and outgoing regulatory activities/communications for ANDAs/OTCs which may include submissions to FDA and Corresponding Acknowledgements, ANDA Amendments and Responses to CRL (minor/major), DRLs and IRs. The US Office is responsible to communicate these updates to the identified Sr. Management on a timely basis including R&D for unapproved products, RA India including post-approval team for post-approval activities. The email list is provided for such communications which includes Commercial Division Heads, R&D, QA, Legal, Business Development, Project Management, Demand Planning, Marketing and others identified on the list. It’s very important that these communications be shared with the FDA on a timely basis (typically the same day received from the FDA). Separate communications received from the FDA to support GLS will be sent to the GLS leadership team as identified., • Support OTC submissions, as needed, for ANDA conversion to OTC or OTC Monograph direct including any labeling reviews and updates., • Ensure all manufacturing, packaging, labeling, testing and BA/BE sites are registered with FDA in the CDER Portal, as applicable, • Ensure the payments are made on the scheduled due date to support all manufacturing sites., • Submit all Recalls and FARS to FDA for ANDAs and OTCs, as needed to support commercial. Submit subsequent updates to Recalls / FARS to FDA on a timely basis to meet the required deadline., • Submit controlled correspondences for R&D through CDER NextGen Portal., • Submission of PLAIRS accurately and timely as provided to the US Office., • Shipping samples to the FDA for CDRH evaluation of devices., • Submit pre-ANDA Meeting Packages to FDA, as needed, • Submit Responses to FDA Observations to support manufacturing sites, as needed Qualifications Education • Extensive experience in the pharmaceutical industry with at least 10+ years’ experience in a regulatory affairs., • Primary experience must be managing a significant number of generic drug products (ANDAs & OTCs)., • Capable and has the desire to manage at direct reports, as assigned., • Excellent communication skills including: verbal, reading and writing., • Use various labeling software tools such as TVT and/or Global Vision. Can be trained and have direct reports trained according to support labeling., • Proficient using MS word, MS excel, reviewing Drugs@FDA databases, USP database, FDA Orange Book, DP Specifie Bioequivalence Guideline and Dailymed Labeling, • The successful candidate must be proactive in reading and understanding assigned materials including FDA guidance, 21 CFR, USP general chapters, USP specific monographs, and internal SOPs as assigned., • The candidate must be a highly motivated, willing to be trained and be a self-learner in order to execute assigned tasks with attention to the details., • This will require direct prior experience doing the described activities., • It will in some instances require training, reading internal Standard Operating Procedures (SOPs), in-person training, and training by viewing FDA SBIA learning on-line video seminars or reading FDA guidance., • Read and understand current FDA guidance(s) and trends, USP general/specific DS/DP monographs, and be familiar with ICH guidelines and post-approval change guidance(s) accordingly., • Communicate with Supervisor and other Sr. Management on a timely basis when potential issues/concerns arise., • Use critical thinking skills and attention to detail is essential., • Ask questions and/or advice when in doubt., • The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties., • The noise level in the work environment is typical of that of an office, • Incumbent may encounter frequent interruptions throughout the workday. Salary Range - $160,000 – 185,000 The compensation range provided reflects the expected base compensation only and does not include potential bonuses, incentive plans, or benefits. An individual’s final compensation offer will be based on a variety of factors, including but not limited to education level, relevant experience, training, and geographic location. Benefits include: • Paid time off, • 401k plus company match, • Company paid health benefits, • Dental, • Vision, • Onsite access to company gym, • Paid Employee Referral Program, • EAP – Employee Assistance Program, • Accident Insurance, • Critical Illness Insurance, • Short-Term Disability, • Life and AD & D Insurance, • Whole Life Insurance, • Pet Insurance and so much more! About the Company Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve people’s lives every day by helping to reduce their healthcare costs while delivering high-quality medicines. Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States. Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live. This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice. Glenmark Pharmaceuticals is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job DescriptionWho we are… Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer. What you’ll be doing The Director, Publications & Medical Strategy is an integral member of the Medical Affairs Team. This individual, in conjunction with the Medical Strategy Lead, will be responsible for developing and executing the publication plans, as well as supporting evidence generation plans for taletrectinib and NSCLC. He/she/they must work collaboratively with cross-functional counterparts in Development, Research and Commercial as well as other partners in the organization to drive execution of the Publication and Evidence Generation plans. This individual will develop deliverables including integrated evidence generation plans for taletrectinib, scientific publications, and scientific communication platforms. Key aspects of the role include the development and execution of a forward-thinking evidence generation strategy for taletrectinib, including execution of the publication and medical communications strategy, data gap analysis, and integrated evidence planning. You will be responsible for… • Collaborate directly with executive leadership, Clinical, Medical Affairs, Biostatistics colleagues and external authors to shape and execute the medical communication strategy and evidence generation plans, • Lead the development and execution of comprehensive strategic publications for the company portfolio assets, in alignment with corporate and medical objectives, • Guide the creation and refinement of scientific communications materials such as QA, slide decks, and scientific platforms based on publications; ensure consistency and strategic messaging across publications and communication channels, for the lead assets in NSCLC and glioma., • Drive prioritization and decision-making for key publications; anticipate and resolve challenges related to data dissemination and stakeholder alignment., • Ensure all publications adhere to ICMJE, GPP, and internal compliance standards., • With Medical Strategy Lead, support the development and execution of an Evidence Generation Plan for taletrectinib, including the Publication Plan and ISR strategy., • With Medical Strategy Lead, develop and execute external research and collaborations (ISR) strategy that is aligned to company goals and prioritized data gaps., • Evaluate ISR concepts & protocols to ensure scientific rigor and alignment with Medical Affairs strategy., • Additional responsibilities as assigned in Medical Strategy.What Knowledge & Experience you'll bring to us..., • Advanced degree in life sciences (PharmD, PhD, Doctor of Nursing Practice, or MD), • 5+ years minimum experience in biotech and/or pharmaceutical industry, • An equivalent combination of education and experience may be considered, • Experience writing, developing peer-reviewed scientific publications required; CMPP preferred, • Understanding of publication best practices, GPP/ICMJE guidelines, and regulatory-compliant scientific communication., • Oncology experience required; NSCLC experience preferred., • Experience conducting gap assessments and executing evidence generation plans including the developing and running of medical affairs company sponsored studies, such as EAP and ISRs, • Experience managing agencies and/or vendors., • Excellent verbal, written, and presentation skills with the ability to effectively communicate complex scientific data to diverse audiences, • Works independently. Thrives in a fast-paced, dynamic environment and can manage multiple priorities at one time with little direction, • Ability to travel to Nuvation Bio Headquarters and professional congresses as appropriate (~25%)Behavioral skills to be successful..., • Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges., • Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives., • Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource., • Emotional intelligence, curiosity, and a knack to figure out a way to build something better, • Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders., • Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity., • Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.What we have for you!, • Competitive Base Salary, Bonus, and Equity Plans, • Unlimited Vacation and 10 Sick Days Annually, • Excellent Medical, Dental, and Vision Coverage, • 401K with Company Matching Disclaimer Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law. This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.

Job DescriptionINTERNATIONAL FEDERATION OF ACCOUNTANTS (IFAC) During 2024, IFAC shifted its strategic focus to maximizing member value and experience. The Member Value Proposition (MVP) was created and is currently being embedded into all of IFAC’s activities: • IFAC, by connecting and uniting its members, makes the accountancy profession truly global., • IFAC member organizations are champions of integrity and professional quality and proudly carry their membership as a badge of international recognition., • IFAC and its members work together to shape the future of the profession through learning, innovation, a collective voice, and commitment to the public interest.IFAC has traditionally delivered member services from a centralized operating model based in New York. As part of the transformation to a new target operating model, IFAC will move to a global multi-location model, which will greatly enhance our ability to deliver value to member organizations around the world. As part of this shift, we welcome applicants from around the globe to apply and contribute to our mission. POSITION SUMMARY The Head of Global Advocacy and Market Insights drives IFAC’s strategic advocacy agenda by shaping the organization’s thinking and providing the market intelligence that underpins its priorities. This role focuses on generating insights, frameworks, and analyses that inform IFAC’s positioning and strengthen its influence with key stakeholders, including regulators, policymakers, standard setters, business leaders, investor communities, and global institutions. In addition, the role oversees research into global trends, regulatory developments, and market dynamics affecting the accountancy profession. These insights serve as the foundation for IFAC’s advocacy strategy, organizational decision-making, and member engagement worldwide. The Director works closely with the senior leadership and regional teams to ensure IFAC’s voice is effectively represented on global platforms and that the organization remains proactive and responsive to emerging issues shaping the profession’s future. ESSENTIAL DUTIES & RESPONSIBILITIES Essential duties and responsibilities include those that are set out below. Other duties may be assigned to meet business needs. Global Advocacy • Develop and lead IFAC’s global advocacy strategy, aligning external engagements with organizational goals and the MVP., • Represent IFAC in global forums, conferences, roundtables, and high-level meetings with regulators, policymakers, and key stakeholders., • Leverage a well-established network of relationships with senior executives and CEOs from international financial institutions, multilaterals (e.g., OECD, IMF), regulatory bodies, standard setters, and professional networks, actively engaging with these stakeholders to advance IFAC’s strategic priorities and global influence., • Collaborate with communications teams to craft compelling advocacy messaging and thought leadership pieces that promote IFAC’s positions on critical issues., • Act as a spokesperson for IFAC, deliver presentations, and contribute to publications.Market & Regulatory Insights, • Lead the monitoring and analysis of global market trends, regulatory developments, geopolitical risks, and technological shifts impacting the accountancy profession and broader business environment., • Overseeing the production of market intelligence reports, briefings, and insights for senior leadership, governance bodies, and member organizations., • Support and prepare other departments, particularly the Member Experience and Engagement (MEE) Leads, by providing analysis and briefing materials on advocacy and regulatory matters, enabling them to deliver effective external presentations and stakeholder briefings., • At the discretion of the CEO, potentially serve as a spokesperson for IFAC by delivering presentations, representing the organization in select external forums, and contributing to thought leadership presentations., • Collaborate with other departments to integrate insights into organizational strategy, policy positions, and member engagement., • Identify emerging opportunities and risks that may influence the profession’s role or regulatory landscape., • Oversee external research partnerships and relationships with think tanks, academic institutions, and research organizations., • Manage, lead, mentor, and develop a high-performing team focused on the MVP, advocacy and market insights., • Manage departmental budgets and expenses.Content Management, • Manage and oversee the execution of IFAC’s offerings and experience strategy., • Bachelor’s degree, or an equivalent required; advanced degree in Business, Economics, International Relations, Public Policy, or a related field preferred; Professional accountancy qualification (e.g., CPA, CA) strongly preferred., • 15+ years of progressive experience in administration, public policy, regulatory affairs, advocacy, or professional services leadership, preferred., • Proven ability to lead high-performing teams across cultures and geographies., • Deep understanding of global trends and regulatory environments impacting the accountancy profession., • Exceptional interpersonal skills, with the ability to work effectively with senior executives, boards, committees, and diverse cultural groups., • Excellent negotiation, diplomacy, and issue-resolution skills, with the ability to achieve consensus among varied viewpoints., • Strong organizational skills and ability to manage multiple priorities and deadlines, including those imposed externally., • Commitment to quality processes and high-quality deliverables., • Flexibility and adaptability in a dynamic environment IFAC welcomes applicants from all geographical locations, and this role can be remote if outside of the NY-Metropolitan area. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At IFAC, compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for candidates in the NY-Metropolitan region is $200,000 to $250,000. IFAC is an equal employment employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status, or any other legally protected basis, in accordance with applicable law. Powered by JazzHR V6LpE53WaN

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways. Job overview: Step into a pivotal role as our CMC Regulatory Manager, where you will support the development and execution of the CMC regulatory strategy, authoring and reviewing the critical submissions that will shape the pathway for our first-in-class investigational product. Location: Hybrid in our New York City office or remote on the East Coast, USA. Reports to: Associate Director, Regulatory Affairs CMC. Roles and responsibilities (Include but are not limited to): • This role is pivotal in liaising with cross-functional teams to prepare and maintain CMC sections of submissions, as well as responding to Health Authority queries throughout the product lifecycle, • Participate in the development of the CMC regulatory strategy, • Author and review CMC regulatory submission documents including: IND updates, NDA filings, and responses to health authorities through collaborations with relevant line functions, • Review technical documentation, as necessary, • Develop CMC strategies, assess risks, and develop contingency plans, • Develop and maintain knowledge of regulatory environment, regulations, and procedures, • Prepare and review CMC regulatory documentation and identify any potential risks including content, quality, or timeline issues as early as possible, • Bachelor's Degree in life sciences or engineering, or other technical discipline, • Considerable industry experience, with 3+ years in CMC regulatory specifically, • Experience with CMC regulatory documents (IND/CTAs, NDAs, MAAs, responses, etc), • Knowledge and understanding of FDA, EMA and/or ICH guidelines and CMC regulations, • Experience in drug development processes and post-approval requirements, • Experience in developing CMC regulatory strategy Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$120,000—$170,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description About Child Mind Institute We're dedicated to transforming the lives of children and families struggling with mental health and learning disorders by giving them the help they need. We've become the leading independent nonprofit in children's mental health by providing gold-standard evidence-based care, delivering educational resources to millions of families each year, training educators in underserved communities, and developing tomorrow's breakthrough treatments. Position Details: The Director of Government Relations will lead our efforts to engage and influence policymakers at the city, state, and federal levels and grow public revenue to support our mission. You will blend advocacy, fundraising, and relationship management – building deep partnerships with government agencies, elected officials, and public funders at the city, state, and federal levels. You are a government affairs professional with experience securing public funding, influencing policy, and opening doors in key jurisdictions. You will be a strategic thinker, persuasive communicator, and passionate champion for children's mental health and learning equity. Reporting to the Senior Vice President, National Programs, this is a full-time, exempt, hybrid (in office a minimum of 4 days per week) position. You Will: • Government Relations & Advocacy, • Lead our government relations efforts across city, state, and federal levels., • Build and maintain trusted relationships with elected officials, agency leaders, legislative staff, and coalition partners., • Monitor policy, regulatory, and budget decisions relevant to children's mental health, education, and family well-being., • Draft policy briefs, testimony, position statements, and talking points for internal and external audiences., • Facilitate high-level engagements between organizational leaders and key stakeholders., • Public Sector Fundraising, • Proactively identify and pursue opportunities for government funding, contracts, and grants to support programs and strategic initiatives., • Lead or support proposal development in partnership with program, finance, and development teams., • Cultivate relationships with public funders and decision-makers to position us as a trusted provider and expert., • Track funding pipelines, timelines, and requirements in priority states and cities., • Leadership & Collaboration, • Be a senior external representative of the organization, including participation in policy coalitions, advisory groups, and public events., • Collaborate with the Chief Development Officer and Chief Marketing Officer to ensure alignment and integration of organizational growth and brand and fundraising strategies., • Manage and/or coordinate with contract lobbyists, policy consultants, and state-level leads., • Minimum of 10 years of experience in government relations, public affairs, or public sector fundraising, with a demonstrated ability to secure public funding and influence policy outcomes., • Bachelor's degree, • Extensive network of relationships with government officials and public agencies at city, state, and/or federal levels., • Experience with legislative, regulatory, and budget processes, especially those related to health, education, and human services., • Experience generating revenue through public funding sources such as government contracts, grants, appropriations, and reimbursement mechanisms., • Willingness to travel (up to 30%). #LI-hybrid Our Benefits Our great compensation package and benefits include medical insurance, 401(k), paid parental leave, dependent care, flexible work schedules, discounted tickets and entertainment perks programs. For more information about our benefits, please visit our employee benefits website. Pay Range The salary range for the position is posted. Factors such as candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations affect the salary offered within this range. In addition, this salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting. EEO Disclaimer Child Mind Institute is committed to fostering an inclusive and equitable workplace where all individuals are treated with respect and dignity. We are proud to be an equal opportunity employer and prohibit discrimination and harassment of any kind. We provide equal employment opportunities to all employees and applicants for employment, regardless of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity, gender expression, age, national origin, ancestry, citizenship status, marital status, military or veteran status, physical or mental disability, genetic information, medical condition, or any other characteristic protected by applicable federal, state, or local laws. In compliance with California law, we also prohibit discrimination based on reproductive health decision-making, status as a victim of domestic violence, sexual assault, or stalking, or any other category protected by the California Fair Employment and Housing Act (FEHA). In New York, we extend this prohibition to include status as a victim of domestic violence, familial status, or any other characteristic protected by the New York State Human Rights Law (NYSHRL). Child Mind Institute is dedicated to ensuring accessibility and reasonable accommodations for individuals with disabilities or medical conditions. If you require an accommodation to participate in the application process or perform your job, please contact our HR Department at This policy applies to all aspects of employment, including recruitment, hiring, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, benefits, and training.

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Candidates must be local and work hybrid out of: Lake County, IL; San Francisco, CA; Irvine, CA; Florham Park, NJ The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients. Responsibilities: • Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for evidence generation)., • Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects., • Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately., • Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff., • Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures., • Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics department., • (Clinical Statistics) Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements. Qualifications • MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field., • High degree of technical competence and excellent communication skills, both oral and written, • Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others, • Able to manage project timeline and quality of deliverables, • Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo, • Have strong leadership skills and experience in working/managing cross-cultural or oversea teams, • Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Description A rapidly growing biotech is seeking a Director Regulatory CMC to serve as an RA CMC expert and strategic leader to bring a hands-on approach to a mission-driven organization. This team is composed of world-class scientists and innovators who are leading the charge on integrating advanced imaging and AI technologies to revolutionize drug discovery The Director, Regulatory CMC will be responsible for leading the development and execution of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical products. The ideal candidate will have a strong understanding of global regulatory requirements and guidelines related to CMC, along with experience managing regulatory affairs activities within the biotech or pharmaceutical industry. Key Responsibilities: • Develop and execute regulatory strategies for CMC components of pharmaceutical development programs., • Prepare and submit high-quality regulatory documentation to global health authorities., • Serve as the primary CMC regulatory contact with regulatory agencies., • Lead and mentor a team of regulatory professionals., • Collaborate cross-functionally to ensure alignment with regulatory expectations and timelines., • Stay current with evolving regulatory requirements and industry best practices., • Provide strategic input on CMC development plans to ensure regulatory compliance., • Support regulatory inspections and audits related to CMC activities., • Contribute to the development of internal regulatory policies and procedures. Qualifications • Advanced degree (PhD, PharmD, MS) with 10+ years of relevant experience, or a Bachelor's degree with 12+ years of experience in regulatory affairs focused on CMC., • Recent experience in small molecule drug development is required., • Demonstrated experience authoring and compiling regulatory dossiers., • In-depth knowledge of global CMC regulatory guidelines and submission processes., • Proven leadership experience managing regulatory teams., • Strong interpersonal and communication skills, with the ability to work effectively across disciplines., • Ability to manage multiple priorities in a dynamic environment.

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Associate Director, Statistics - Immunology provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients. This role will work a hybrid work schedule from one of the AbbVie locations: • Lake County, IL, • Provide statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission., • Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans., • Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, and GMA, etc.) to create development strategies for assigned projects., • Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately., • Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff., • Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures., • Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics Department., • MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field., • High degree of technical competence and excellent communication skills, both oral and written, • Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others, • Able to manage project timeline and quality of deliverables, • Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo, • Have strong leadership skills and experience in working/managing cross-cultural or oversea teams, • Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment., • (SSG) Experience leading safety-related projects (eg, ISS, benefit-risk assessment, signal detection), • (GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionThe New York Climate Exchange (The Exchange) is a not-for-profit climate solutions center designed to advance progress on pressing climate challenges and opportunities, through an interdisciplinary coalition approach, impactful programming, and cutting-edge facilities. While The Exchange will have a physical presence on Governors Island, its spirit and influence will extend beyond the Island into New York City, across the country, and the world. Our diverse consortium—committed and prepared to collectively disrupt the status quo—incorporates local and global perspectives on climate change from academia, the private sector, and community-level organizations. As the first of its kind, The Exchange will unlock integrated and scalable approaches to climate action, ultimately serving as a global model for sustainable positive change. The New York Climate Exchange (“The Exchange”) is seeking a seasoned and strategic Director of Finance & Administration to lead the organization’s core financial and administrative functions. This senior-level role will be responsible for driving excellence across finance, human resources, IT, procurement, compliance, and facilities management, ensuring that The Exchange’s infrastructure supports its ambitious mission. The ideal candidate will bring a proven track record of leadership in complex, fast-paced environments, with a strong orientation toward building systems, leading high-performing teams, and aligning operations with strategic goals. This is a full-time, in-person role based in New York City, with flexibility for periodic remote work. This position reports directly to the Chief Executive Officer and serves as a key member of the senior leadership team. Salary and Benefits Salary for the Director of Finance & Administration is between $200,000 – $250,000 per year. The position includes eligibility for generous health and retirement benefits, and paid time off/sick leave. Salary will be set based on a variety of factors, including but not limited to qualifications, experience, education, licenses, and specialized training. The above hiring range represents The Exchange’s good faith and reasonable estimate of the range of possible compensation at the time of posting. Responsibilities Working closely with the leadership team of The Exchange and its Board of Directors, significant responsibilities include: Strategic Financial Leadership • Serve as the organization’s senior financial officer, overseeing all aspects of financial strategy, planning, budgeting, and reporting., • Lead long-term financial forecasting and scenario planning to support strategic decision-making., • Ensure robust financial controls, compliance with GAAP, and timely, accurate financial reporting to the CEO and Board., • Oversee relationships with external auditors, financial institutions, and key vendors., • Drive financial innovation and operational efficiency through systems improvements and data-driven insights.HR, Operations, & Infrastructure, • Oversee core HR functions including payroll, policy development, recruitment, onboarding, benefits, performance management, and offboarding., • Manage relationships with HR service providers to ensure effective and aligned service delivery., • Provide oversight of all administrative functions, including IT, procurement, and space management., • Expand and evolve the implementation of scalable systems, policies, and procedures to support organizational growth., • Partner with external service providers to ensure high-quality, cost-effective delivery of services., • Enhance and maintain enterprise-wide compliance structures aligned with legal, regulatory, and ethical standards., • Lead risk management efforts, including internal audits, data privacy, and business continuity planning., • Build and lead a high-performing administrative and financial management team, fostering a culture of accountability, collaboration, and continuous improvement., • Mentor and develop staff, creating clear pathways for growth and leadership within the organization., • Implement strategic learning and development initiatives to enhance employee skills, drive engagement, and support organizational growth., • Partner with programmatic and external affairs teams to align operational capacity with mission delivery., • Lead cross-functional initiatives that enhance organizational effectiveness and impact., • Minimum of 10 years of progressive leadership experience in finance, operations, or administration, preferably within mission-driven, complex, or start-up environments., • Bachelor’s degree required in business administration, finance, public administration, or a related field; MBA or equivalent advanced degree preferred., • Demonstrated expertise in financial strategy, budgeting, compliance, and operational oversight at the senior level., • Proven ability to build and lead high-performing teams, manage cross-functional initiatives, and drive organizational change., • Strong understanding of HR, IT, procurement, and space planning, with experience overseeing external service providers and internal teams., • Exceptional strategic thinking, problem-solving, and decision-making skills, with a track record of aligning operations with organizational goals., • Develops and implements solutions that show understanding of how partners and/or own work achieves results that are financially, environmentally, and socially sustainable., • Shares new insights based on in-depth understanding of clients/partners and recommends solutions for current and future needs of clients/partners., • Initiates collaboration across boundaries and broadly across The Exchange, partner organizations, and other relevant institutions., • Makes choices and sets priorities with The New York Climate Exchange corporate perspective in mind., • Helps others to understand problems, partner and client needs, and the underlying context., • Recognizes the value of diverse perspectives and lived experiences and applies a critical lens to systemic sources of bias and discrimination., • Applies critical thinking and seeks input and experience from others to recommend a course of action consistent with The Exchange’s strategy., • Evaluates risk and anticipates the short- and long-term implications of decisions. The New York Climate Exchange provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, height, weight, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Research indicates that men tend to apply for jobs when they meet just 60% of the criteria, while women and people from other marginalized groups only apply if they are a 100% match. If you are passionate about our mission and think you have what it takes to be successful in this role even if you don’t check all the boxes, please apply. We’d appreciate the opportunity to consider your application. You must be able to work in the United States as The Exchange does not yet have visa-sponsoring capabilities. Powered by JazzHR 9ChoYMUhWh

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description AbbVie’s Business Evolution Strategic Development (BESD) Team is responsible for developing and executing forward-looking strategies that will ensure AbbVie’s readiness for, and ability to successfully navigate, potential changes in the healthcare environment. We are looking for a highly strategic and collaborative Senior Director, BESD to support critical enterprise efforts to tackle emerging disruptors. This role reports to the Vice President, BESD. This role may sit at one of these US based Corporate Regional Office: North Chicago, New Jersey, Boston, D.C. Qualifications Responsibilities: • Lead the assessment and strategy development to navigate pharmaceutical price reform in the US today and in the future, and constantly consider new ideas and strategies that could support AbbVie’s objectives and goals., • Shepherd the development and execution of bold, integrated, environment shaping strategies as well as business readiness strategies through collaboration with dedicated cross-functional and external experts., • Foster a highly collaborative and positive working environment to power the execution of high impact, actionable strategies to advance the goals of the business., • Collaborate and serve as a strategic partner to critical cross-functional stakeholders, including Government Affairs, Market Access, Legal, Finance and Corporate Affairs; ensure alignment and drive key strategies and recommendations forward toward identified objectives and milestones., • Coordinate analysis, discussion and co-creation of ideas and solutions among cross-functional working groups., • In partnership with key functions and vendors, constantly monitor and analyze the external environment to understand evolving political, regulatory, legislative, and market dynamics. regarding price reform, and understand varying actions and behaviors of external stakeholders., • Evaluate opportunities that may unlock business value to support meaningful recommendations and business case that accelerate innovative solutions, competitiveness, and business impact., • Vision and Strategy: Leverage breadth of policy and business experience to provide overarching leadership and direction for price reform vision, strategies, plans and resource investment for AbbVie stakeholders. Align and lead the charge. Encompass an enterprise mindset and perspective in all strategies., • Action and Accountability: Own responsibility for strategies within relevant workstreams, and engage and inspire cross functional stakeholders to advance towards clear objectives and strategies; make quick, but informed decisions, as appropriate, to ensure best paths forward in the midst of change market and policy dynamics. Constantly engage, guide, and support cross-functional team to address roadblocks, challenges, resourcing constraints and other dynamics., • Leadership and Influence: Influence and persuade across multiple external and internal stakeholders. Lead and guide direct, indirect and cross-functional teams., • Minimum of 10 years of progressively responsible experience in business consulting, government affairs, public policy, advocacy, or market access with a pharma company, trade association, government agency, think tank, or management consulting firm., • Strong business acumen with demonstrated experience in strategically and creatively shaping policy and business outcomes, with a keen understanding of what it takes to do so effectively., • Exceptional communications and executive presence, critical thinking and interpersonal skills, strong ability to influence without authority, the ability to speak and write persuasively and with clarity, strong organizational skills, flexibility, and adaptability to changing requirements, resourcefulness and creativity, strong attention to detail, a proven track record of being able to work drive towards deadlines and an ability to work collaboratively in a fluid organizational and external environment., • Well-honed political sensitivities and the utmost integrity while having the executive presence and acumen necessary to deal effectively with and anticipate the needs of stakeholders such as senior leaders, third parties, policymakers and others., • Must be an individual who works well in a team environment and enjoys working in a collegial, collaborative and fun, yet highly demanding culture., • Bachelor’s degree required; MBA or other advanced degree in relevant field preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Scientific Director, Medical Affairs provides medical and scientific strategic and operational input into core hematology medical affairs activities such as: health-care professional and provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines, and value proposition); safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical and marketing activities (promotional material generation and product launches) and market access. Collaborates with Clinical Development on Medical Affairs support of priority trials. This position is ideally based at our headquarters just outside of Chicago, IL, but can also be based from our San Francisco, CA or Florham Park, NJ sites. Position will follow a hybrid schedule of 3 days/week onsite. Responsibilities • Responsible for the development of brand strategies and medical functional planning., • Leads and supports Medical Affairs initiatives for the target indication., • Develops and executes Medical Affairs support of priority clinical development trials., • Contributes to the development of and leads the execution of the Medical Education / Advisory Board & EE Engagement Plan generation in line with TA plan. Lead the individual (Global) Conference planning and execution., • Generates clinical and scientific data per evidence gap assessment., • Responsible for managing budget for assigned projects., • Aligns Medical education and scientific initiatives with Sci Comm Platform. Informs Investigator Initiated Study (IIS) strategy and may act as Docent for IISs., • Contributes to the generation of MI communication content and supports training on Medical Information (MI) materials., • Participates in design and execution of clinical trial safety, product safety and risk management plans., • Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.Qualifications, • Advanced Degree PhD, PharmD, PA, NP or MD. Residency or additional post doctorate experience preferred., • Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required., • 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred., • Prior oncology experience required with hematology experience preferred., • Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is preferred., • Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols. May have performed protocol design in the academic environment and/or acted as an assistant PI., • Ability to run a clinical study independently with little supervision., • Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc., • Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written communication skills., • May coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects., • May assist as consultant and liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities., • Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc., • Exercises judgment within well-defined practices and policies. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionSummary The Compliance Director will be responsible for compliance oversight across APG, developing compliance strategies, conducting risk assessments and compliance audits, managing risk, and ensuring that all pharmacy operations align with industry standards and best practices. This role will play an active and integral part in ensuring adherence to federal, state, and local regulations as well as internal APG policies. The Compliance Director collaborates with leadership, the legal team and regulatory agencies to maintain the highest level of compliance and patient safety. Duties and Responsibilities They include the following and other responsibilities may be assigned as needed: Regulatory Compliance & Oversight: • Ensure operations comply with federal, state and local regulations, including but not limited to FDA, DEA, CMS, HIPAA and state pharmacy boards., • Monitor changes in laws and regulations, updating policies and procedures accordingly., • Develop, implement, and maintain pharmacy compliance policies, standard operating procedures (SOPs), and Code of Conduct & Ethics., • Educate staff on regulatory requirements, ethical standards, and internal policies to ensure proper adherence., • Conduct regular risk assessments and implement mitigation strategies., • Lead internal audits to assess compliance and identify areas for improvement., • Investigate compliance violations, document findings, and implement corrective action plans., • Develop and conduct compliance training programs for pharmacy staff, ensuring awareness of laws,regulations, and company policies., • Work closely with pharmacy leadership, legal counsel, and quality assurance teams to develop and maintain compliance frameworks., • Act as a compliance advisor to pharmacy operations, providing guidance on risk mitigation and best practices., • Oversee compliance with DEA regulations, including controlled substance handling, storage, and record-keeping., • Bachelor’s degree in pharmacy, Regulatory Affairs, Accounting, or a related field (PharmD preferred).5+ years of experience in pharmacy compliance, regulatory affairs, or a related field., • In-depth knowledge of federal and state pharmacy regulations, including DEA, FDA, CMS, and state pharmacy boards., • Experience conducting audits, risk assessments, and investigations., • Juris Doctor is a plus. Knowledge, Skills and Other Abilities, • Strong leadership, analytical, and problem-solving skills., • Excellent communication and ability to work cross-functionally with various departments., • Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required., • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required., • Ability to write reports, business correspondences, complete applications, and procedures required., • Ability to effectively present information, deliver training, and respond to questions from groups of colleagues, managers, partners, and customers required., • Ability to demonstrate critical thinking is required., • Ability to manage multiple projects and deadlines., • Ability to work independently on tasks., • Proficiency in MS Office applications required. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to walk; sit and use hands. The employee is occasionally required to stand.

Job Description Position: Middle School Principal Location: Bronx, NY Compensation: $150,000 base (commensurate with experience) Who We Are Public Prep Academies are single-gender K-8 schools and co-ed PreK dedicated to academic excellence and whole-child development. We combine rigorous academics with social-emotional learning, fostering strong partnerships between families and staff to create a supportive, community-focused environment.Our commitment extends to investing in our educators, offering tailored professional development, coaching, and feedback cycles to promote growth, collaboration, and data-driven decision-making. At Public Prep, we cultivate a joyful, inclusive, and high-achieving culture for both scholars and staff. Why Join Public Prep? • Growth Opportunities: Individualized professional development, coaching, and collaboration., • Mission-Driven Culture: Create engaging lessons, foster strong relationships, and make a lasting impact on scholars and families. Who You Are Our ideal candidate for a Principal has an unwavering belief that our scholars can achieve at an exceptionally high level. Beyond that, they are: • Deeply committed to serving our kids. You have elected to work with historically underserved scholars, and do this work because you believe that all scholars, regardless of background, are capable of excellence - and that it’s on us as adults to get our kids there. You can speak knowledgeably about our mission, and demonstrate a commitment to our educational model. You understand that the challenges faced by scholars in New York City are unique and specific, and you’re excited to work within the communities we serve., • A proven school leader, and a driver of results. You've demonstrated the ability to drive results in the pursuit of an ambitious vision and strategy, and you combine your exceptional strategic, analytical, and critical-thinking skills with your use of data to drive decision-making to achieve ambitious outcomes. You’ve got a background in instructional excellence, and leadership, and have both achieved your own impressive results in the classroom and have moved other teachers and leaders to do the same., • A people developer. You’ve led, directly managed, and coached teams and individuals to achieve strong results for scholars. You love and actively seek opportunities to develop others through ongoing coaching, clear expectations and accountability, strong inspirational and motivational skills, high leverage feedback, and targeted professional development., • ...and a people leader. Let’s be real - managing people is hard. You’ve coached, directly managed, and demonstrably moved the effectiveness of other adults before taking this job. You build relationships across lines of difference, authentically inspire and motivate others to buy into your vision, navigate challenging conversations with finesse, make tough calls, communicate effectively in all formats, give and receive feedback fluidly, and model/hold a high bar for adult excellence and exuberance., • A masterful executor. You appreciate the big picture, but you know it's all in the details. Your organizational systems ensure you get things done. You prioritize your time and fervently plan to maximize the time each day you spend moving adult practice. You do the things you say you’ll do, and you communicate when you won’t. You delegate when needed, set deadlines, and hold others accountable to get across important finish lines., • An A+ Communicator. You’ve got a knack for speaking and writing clearly, succinctly and persuasively. You think about time, place, and format to share a message that will resonate to accomplish your goals., • A gritty problem-solver. You keep it cool when facing challenges, approach problems with viable solutions, and know when you need to roll up your sleeves to support your team.The Principal will drive rigorous instruction and create a culture of academic ownership by:, • Ensuring that scholar achievement results for all demographics (GenEd, SpEd, ELL, etc.) meet or exceed school-level targets across academic assessment tools;, • Engaging in clearly defined processes and structures for planning, executing, assessing, and reflecting on the implementation of coherent instructional programs and pedagogical approaches within classrooms, grade levels, and departments throughout the school grounded in the expectations for Common Core-aligned instruction;., • Working alongside the school leadership and home office teams to drive teacher improvement by creating and implementing systems, structures, and opportunities that support and develop teachers to implement rigorous, College and Career-Ready standards and lead to high scholar achievement and growth;, • Leading the school in maintaining a rigorous instructional core by ensuring that College and Career-Ready standards-aligned instructional materials and curricular resources are supported and implemented across all classrooms; and, • Building strong relationships with families, scholars, and staff to ensure collective investment in network instructional priorities, initiatives, and expectations.The Principal will empower and develop teachers and leaders by:, • Training and coaching mid-level leaders to effectively move individual teacher instructional practice and, subsequently, scholars’ academic achievement, through high-leverage active coaching and consistent observation and feedback cycles;, • Planning and executing strategies of supportive supervision that is differentiated and proactive (including, but not limited to, classroom observations, intellectual preparation meetings with grade/department teams, providing support in unit unpacking, modeling scholar data debriefs, etc.);, • Owning all aspects of leading, inspiring, managing, and developing a staff of dynamic, driven, and diverse individuals;, • Leading, facilitating, and developing mid-level leaders to facilitate robust school-based professional development that sets staff up to master the fundamentals of classroom management, backward-design planning and intellectual preparation, relationship-building, and communication with scholars and families, data-driven action planning, and implementation of schoolwide cultural, academic, operational, and extracurricular systems and initiatives;, • Directly coaching and managing school-based Academic Directors and Directors of Scholar & Family Affairs and providing dotted line management support to the school-based Director of Operations and Assistant Director of Scholar Support and ensure alignment across the School Leadership Team (SLT) work scopes to reach the network and school-level goals; and, • Creating a culture where all staff give and receive feedback fluidly – both positive and constructive – as part of daily practice to move the entire school forward.The Principal will lead the school’s continued excellence by:, • Overseeing the recruitment, cultivation, and coaching of all staff as well as supporting a broader strategic talent management structure that addresses all stakeholders and roles;, • Nurturing a warm, safe, and rigorous learning environment characterized by experimentation, collaboration, investment and cultivation of all individuals in their roles;, • Recruiting, selecting, and hiring top talent from across the nation to teach, lead, and support the mission and vision of the network;, • Managing the leadership team to develop culture and operational systems and outcomes that create a school environment where scholars feel safe, able to take social and academic risks, and excited to come to school each day;, • Leading the school team to build deep relationships with families and scholars such that key stakeholders are inspired to remain with the school, and are committed to persisting through challenges to produce scholars that are bound for success in college and in life;, • Effectively managing resources by creating, maintaining, and supporting systems that align to the network vision and priorities and ensure a strong learning-focused environment;, • Ensuring evidence-based decision making guides all meetings for scholars who are identified for services and ensure appropriate follow through with necessary stakeholders takes place;, • Making administrative decisions in accordance with applicable laws, regulations, and network policies and procedures (i.e., NYSED, NYCDOE, EEOC, DOL, SUNY, etc.) in decision making and reporting;, • Serving as a liaison to the broader local (and national) educational community to champion the work Public Prep is doing and build a network of supporters committed to seeing our scholars succeed; and, • At least three (3) years demonstrated success improving scholar outcomes in a leadership capacity at an elementary or secondary public or charter school., • An M.A., Ed.M or Master’s degree in Educational Leadership and/or Educational Administration, preferred., • New York State Certification as a School Administrator, preferred., • Salary is commensurate with experience and qualifications., • Health, dental, vision, & 403b Retirement Plan benefits available. 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Job Description About Tonix* Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. About the Role: The Director of Clinical Development will play a pivotal role in shaping the strategic direction of our clinical programs, ensuring that they align with the overall goals of the organization. This position is responsible for overseeing the design, implementation, oversight, and management of clinical trials, including regulatory interactions, with a focus on delivering high-quality data that supports regulatory submissions and product development. The Director will collaborate closely with cross-functional teams, including regulatory affairs, biostatistics, and medical affairs, to ensure that clinical development plans are executed efficiently and effectively. Additionally, this role will involve mentoring and leading a team of clinical professionals, fostering a culture of innovation and excellence. Ultimately, the Director of Clinical Development will contribute to advancing our pipeline and bringing new therapies to market that improve patient outcomes. Minimum Qualifications: • MD or DO degree., • A minimum of 10 years of experience in clinical development within the pharmaceutical or biotechnology industry., • Experience with regulatory submissions to agencies such as the FDA or EMA., • Familiarity with therapeutic areas relevant to our pipeline, such as rheumatology and oncology, and/or development of biologics., • Serve as medical lead on strategic planning and execution of clinical development programs from Phase I through Phase III., • Oversee the design and implementation of clinical trial protocols, ensuring compliance with regulatory requirements, GCP, and industry standards., • Provide medical monitoring support, including reviewing safety data, overseeing eligibility reviews, and ensuring appropriate AE/SAE reporting., • Collaborate with cross-functional teams including nonclinical, CMC, biostatistics, regulatory, safety/pharmacovigilance, and commercial., • Analyze clinical data and prepare reports for regulatory submissions, ensuring accuracy and clarity in communication., • Author and/or provide strategic input on clinical documents including protocols, investigator brochures, INDs, CTAs, and regulatory briefing documents., • Participate in regulatory interactions (FDA, EMA, etc.), including preparation and presentation of clinical data and strategic input into regulatory submissions., • Collaborate with internal and external stakeholders to align clinical development strategies with business objectives., • Manage and mentor a team of clinical research professionals, providing guidance and support in their professional development. The required skills for this role include strong leadership and project management abilities, which are essential for guiding clinical teams and ensuring that projects stay on track. Excellent communication skills are necessary for effectively collaborating with various stakeholders and presenting complex data in an understandable manner. Analytical skills are crucial for interpreting clinical data and making informed decisions that impact the development process. Preferred skills, such as regulatory knowledge, enhance the ability to navigate the complexities of clinical trials and submissions. Overall, a combination of these skills will enable the Director to drive successful clinical development initiatives and contribute to the advancement of innovative therapies. Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $150,000 to $240,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

Job Description Position: Elementary School Principal Location: Bronx, NY Compensation: $150,000 (commensurate with experience) Who We Are Public Prep Academies are single-gender K-8 schools and co-ed PreK dedicated to academic excellence and whole-child development. We combine rigorous academics with social-emotional learning, fostering strong partnerships between families and staff to create a supportive, community-focused environment.Our commitment extends to investing in our educators, offering tailored professional development, coaching, and feedback cycles to promote growth, collaboration, and data-driven decision-making. At Public Prep, we cultivate a joyful, inclusive, and high-achieving culture for both scholars and staff. Why Join Public Prep? • Growth Opportunities: Individualized professional development, coaching, and collaboration., • Mission-Driven Culture: Create engaging lessons, foster strong relationships, and make a lasting impact on scholars and families. Who You Are Our ideal candidate for a Principal has an unwavering belief that our scholars can achieve at an exceptionally high level. Beyond that, they are: • Deeply committed to serving our kids. You have elected to work with historically underserved scholars, and do this work because you believe that all scholars, regardless of background, are capable of excellence - and that it’s on us as adults to get our kids there. You can speak knowledgeably about our mission, and demonstrate a commitment to our educational model. You understand that the challenges faced by scholars in New York City are unique and specific, and you’re excited to work within the communities we serve., • A proven school leader, and a driver of results. You've demonstrated the ability to drive results in the pursuit of an ambitious vision and strategy, and you combine your exceptional strategic, analytical, and critical-thinking skills with your use of data to drive decision-making to achieve ambitious outcomes. You’ve got a background in instructional excellence, and leadership, and have both achieved your own impressive results in the classroom and have moved other teachers and leaders to do the same., • A people developer. You’ve led, directly managed, and coached teams and individuals to achieve strong results for scholars. You love and actively seek opportunities to develop others through ongoing coaching, clear expectations and accountability, strong inspirational and motivational skills, high leverage feedback, and targeted professional development., • ...and a people leader. Let’s be real - managing people is hard. You’ve coached, directly managed, and demonstrably moved the effectiveness of other adults before taking this job. You build relationships across lines of difference, authentically inspire and motivate others to buy into your vision, navigate challenging conversations with finesse, make tough calls, communicate effectively in all formats, give and receive feedback fluidly, and model/hold a high bar for adult excellence and exuberance., • A masterful executor. You appreciate the big picture, but you know it's all in the details. Your organizational systems ensure you get things done. You prioritize your time and fervently plan to maximize the time each day you spend moving adult practice. You do the things you say you’ll do, and you communicate when you won’t. You delegate when needed, set deadlines, and hold others accountable to get across important finish lines., • An A+ Communicator. You’ve got a knack for speaking and writing clearly, succinctly and persuasively. You think about time, place, and format to share a message that will resonate to accomplish your goals., • A gritty problem-solver. You keep it cool when facing challenges, approach problems with viable solutions, and know when you need to roll up your sleeves to support your team.The Principal will drive rigorous instruction and create a culture of academic ownership by:, • Ensuring that scholar achievement results for all demographics (GenEd, SpEd, ELL, etc.) meet or exceed school-level targets across academic assessment tools;, • Engaging in clearly defined processes and structures for planning, executing, assessing, and reflecting on the implementation of coherent instructional programs and pedagogical approaches within classrooms, grade levels, and departments throughout the school grounded in the expectations for Common Core-aligned instruction;., • Working alongside the school leadership and home office teams to drive teacher improvement by creating and implementing systems, structures, and opportunities that support and develop teachers to implement rigorous, College and Career-Ready standards and lead to high scholar achievement and growth;, • Leading the school in maintaining a rigorous instructional core by ensuring that College and Career-Ready standards-aligned instructional materials and curricular resources are supported and implemented across all classrooms; and, • Building strong relationships with families, scholars, and staff to ensure collective investment in network instructional priorities, initiatives, and expectations.The Principal will empower and develop teachers and leaders by:, • Training and coaching mid-level leaders to effectively move individual teacher instructional practice and, subsequently, scholars’ academic achievement, through high-leverage active coaching and consistent observation and feedback cycles;, • Planning and executing strategies of supportive supervision that is differentiated and proactive (including, but not limited to, classroom observations, intellectual preparation meetings with grade/department teams, providing support in unit unpacking, modeling scholar data debriefs, etc.);, • Owning all aspects of leading, inspiring, managing, and developing a staff of dynamic, driven, and diverse individuals;, • Leading, facilitating, and developing mid-level leaders to facilitate robust school-based professional development that sets staff up to master the fundamentals of classroom management, backward-design planning and intellectual preparation, relationship-building, and communication with scholars and families, data-driven action planning, and implementation of schoolwide cultural, academic, operational, and extracurricular systems and initiatives;, • Directly coaching and managing school-based Academic Directors and Directors of Scholar & Family Affairs and providing dotted line management support to the school-based Director of Operations and Assistant Director of Scholar Support and ensure alignment across the School Leadership Team (SLT) work scopes to reach the network and school-level goals; and, • Creating a culture where all staff give and receive feedback fluidly – both positive and constructive – as part of daily practice to move the entire school forward.The Principal will lead the school’s continued excellence by:, • Overseeing the recruitment, cultivation, and coaching of all staff as well as supporting a broader strategic talent management structure that addresses all stakeholders and roles;, • Nurturing a warm, safe, and rigorous learning environment characterized by experimentation, collaboration, investment and cultivation of all individuals in their roles;, • Recruiting, selecting, and hiring top talent from across the nation to teach, lead, and support the mission and vision of the network;, • Managing the leadership team to develop culture and operational systems and outcomes that create a school environment where scholars feel safe, able to take social and academic risks, and excited to come to school each day;, • Leading the school team to build deep relationships with families and scholars such that key stakeholders are inspired to remain with the school, and are committed to persisting through challenges to produce scholars that are bound for success in college and in life;, • Effectively managing resources by creating, maintaining, and supporting systems that align to the network vision and priorities and ensure a strong learning-focused environment;, • Ensuring evidence-based decision making guides all meetings for scholars who are identified for services and ensure appropriate follow through with necessary stakeholders takes place;, • Making administrative decisions in accordance with applicable laws, regulations, and network policies and procedures (i.e., NYSED, NYCDOE, EEOC, DOL, SUNY, etc.) in decision making and reporting;, • Serving as a liaison to the broader local (and national) educational community to champion the work Public Prep is doing and build a network of supporters committed to seeing our scholars succeed; and, • At least three (3) years demonstrated success improving scholar outcomes in a leadership capacity at an elementary or secondary public or charter school., • An M.A., Ed.M or Master’s degree in Educational Leadership and/or Educational Administration, preferred., • New York State Certification as a School Administrator., • Salary is commensurate with experience and qualifications., • Health, dental, vision, & 403b Retirement Plan benefits available. 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Job Description The Regulatory Guidance Manager is responsible for overseeing a team of analysts and ensuring regulatory compliance by disseminating guidance to affected business units. The position will develop and maintain relationships with regulatory agencies and stay up to date on any changes or updates to regulations. The position is accountable for supporting the Director of State Regulatory Guidance and will provide, as well as oversee, the provision of guidance to staff and for conducting regulatory research and analysis to identify and interpret regulatory requirements and trends. The position will be responsible for overseeing a team of analysts with expertise in different lines of business to ensure optimal performance of the department. Job Description • Oversee a team of regulatory analysts to ensure timely dissemination of accurate guidance for applicable laws and regulations related to all NYS regulated Lines of Business (LOBs) that the Plan offers., • Develop and coordinate with the Project Management Team (PMO) and the Product Team on workplans to implement new regulatory changes., • Provide guidance and conduct regulatory research and analysis to help identify and interpret requirements and trends., • Evaluate the impact of regulatory changes on the organization and advise plan leadership on necessary actions., • Develop and maintain relationships with regulatory agencies and stay up-to-date on any changes or updates to regulations., • Participate in stakeholder calls and create summaries of calls for dissemination to senior staff., • Work with the Regulatory Operations team to manage the preparation and submission of regulatory filings, reports, and documentation., • Identify and assess potential regulatory risks and develop strategies to mitigate those risks., • Collaborate with cross-functional teams to ensure compliance across all areas of the organization., • Participate in high-level implementations of carve-in/carve-out services; program services such as changing vendors or adding new vendors., • Participate in various external audits/surveys such as the Article-44 Operational Survey to ensure compliance with state regulations. Upload all requested information into the Health Commerce System (HCS), the state’s database, as necessary., • Supervise a team of Regulatory Specialists assigning tasks and projects and conducting performance evaluations. Ensure that the team is adequately trained and equipped to perform their duties, including identifying and addressing knowledge and skill gaps and that staff are up to date with work assignments and provide guidance as needed. Provide feedback to staff to help improve their productivity, efficiencies and growth., • Bachelor's degree required; and, • 5+ years of Regulatory Affairs work experience; or, • A satisfactory equivalent combination of education, training, and experience in other Managed Care operational departments., • Experience with managing and leading teams., • Master’s degree or Juris Doctorate preferred., • Experience with NY State managed care products strongly preferred., • Strong knowledge of healthcare laws and regulations, including HIPPA, Medicare and Medicaid., • Proficient MS Word, Excel, SharePoint and PowerPoint required.

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world. About the Role The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-approval changes), supporting commercial product lifecycle management, and providing backup to the Director of Regulatory Affairs. The role plays an essential part in ensuring timely, compliant regulatory filings and strategic input for product development, with particular focus on complex generics and combination products. This role also includes supporting GDUFA III-related meeting package preparation. Responsibilities • Compile and submit ANDAs, supplements (CBE/PAS), annual reports, and labeling supplements in compliance with FDA requirements., • Author relevant eCTD sections using company templates and ensure files are properly formatted with bookmarks, hyperlinks, and metadata., • Evaluate proposed product and process changes against current FDA guidance and industry standards. Recommend appropriate filing strategies, timelines, and risk-based approaches for submission planning and execution., • Support regulatory strategy and submissions for complex generics and combination products (e.g., transdermal systems, injectables, drug-device combinations)., • Create and maintain internal templates, trackers, and tools to manage regulatory planning and combination product submissions., • Provide regulatory support for Design History Files (DHFs), ensuring consistency and alignment with FDA expectations for device related documentation., • Prepare formal meeting packages and briefing documents under GDUFA III, including pre-submission and mid-cycle meetings., • Coordinate with internal departments and external partners for documentation collection, timeline management, and regulatory compliance., • Represent Regulatory Affairs in internal cross-functional meetings and external partner calls, as needed., • Lead regulatory activities for post-approval changes including site transfers, analytical method updates, container/closure system changes, and alternative sourcing of materials., • Participate in product development from early-stage formulation to final submission, incorporating FDA feedback and seeking regulatory guidance when appropriate., • Draft, review, and maintain product labeling and promotional labeling, ensuring alignment with current regulations and internal policies., • Review technical documentation and provide regulatory guidance to internal and external stakeholders. Ensure all submissions meet FDA standards, cGMP requirements, and Quality-by-Design (QbD) principles., • Ensure submission documentation is accurate, complete, and in compliance with applicable FDA regulations and company quality standards. Qualifications • Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field required., • Advanced degree preferred. Required Skills • 5+ years’ experience in pharmaceutical regulatory affairs., • Experience with complex and combination products and knowledge of FDA expectations., • Experience with eCTD software, MSWord, Excel, Adobe Acrobat and other document processing software., • Independently compiled and filed ANDAs, • Familiar with cGMP requirements., • Sterile products experience Compensation & Benefits At Breckenridge Pharmaceutical, Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location: • Flexible approach to how we work, • Health benefits and time-off programs, • Competitive compensation packages, • The anticipated annual salary for this role is $88,000-125,000 Equal Opportunity Statement Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job DescriptionOur mission: to eliminate every barrier to mental health. At Spring Health, we're on a mission to revolutionize mental healthcare by removing every barrier that prevents people from getting the help they need, when they need it. Our clinically validated technology, Precision Mental Healthcare, empowers us to deliver the right care at the right time—whether it's therapy, coaching, medication, or beyond—tailored to each individual's needs. We proudly partner with over 450 companies, from startups to multinational Fortune 500 corporations, as a leading provider of mental health service, providing care for 10 million people. Our clients include brands you use and know like Microsoft, Target, and Delta Airlines, all of whom trust us to deliver best-in-class outcomes for their employees globally. With our innovative platform, we've been able to generate a net positive ROI for employers and we are the only company in our category to earn external validation of net savings for customers. We have raised capital from prominent investors including Generation Investment, Kinnevik, Tiger Global, Northzone, RRE Ventures, and many more. Thanks to their partnership and our latest Series E Funding, our current valuation has reached $3.3 billion. We're just getting started—join us on our journey to make mental healthcare accessible to everyone, everywhere. We are seeking a dedicated, experienced, and strategic Director, Government Affairs to join our Legal team. In this role, you will be instrumental in driving our public policy and advocacy efforts at the federal level. This role will be responsible for shaping legislative and regulatory strategies, engaging with policymakers, and ensuring that our policy priorities support the growth and impact of digital mental health. What you'll be doing: • Monitor, analyze, inform, and influence federal legislation, regulatory proposals, and policies related to digital health, behavioral health, privacy, AI, and employee benefits., • Advocate for favorable policies through direct engagement, coalition participation, and public comment sessions., • Represent the company in trade associations, industry coalitions, and advocacy groups, ensuring our policy priorities are well-positioned., • Build and maintain relationships with policymakers, regulators, and industry leaders to advance shared goals., • Translate complex policy developments into clear, actionable insights for internal teams, helping shape corporate strategy, business development, and market expansion., • Keep leadership and business stakeholders informed about emerging legislative and regulatory challenges and opportunities., • Collaborate with core teams (e.g. Legal, Product, Clinical and People) to align regulatory strategy with business objectives., • Identify opportunities to influence rulemaking and regulatory frameworks impacting our products and services., • Craft compelling policy briefs, white papers, and advocacy materials to educate policymakers, industry leaders, and internal stakeholders on key issues in digital and behavioral health., • Keep a pulse on legislative and regulatory changes, flagging emerging risks and opportunities that could impact the business., • Provide timely internal reports on rulemaking, legislative priorities, and administrative shifts., • Draft and submit public comments on proposed regulations that align with the company's strategic goals., • Actively participate in key industry groups, trade associations, and coalitions, ensuring our policy interests are well-represented., • Deliver actionable policy insights to internal stakeholders, shaping corporate strategy and decision-making., • Bachelor's Degree, • 7+ years of experience in trade associations, government relations or industry advocacy - preferably with Hill experience in a staff role., • Advanced understanding of the legislative process, regulatory decision-making, and how to navigate the complexities of government policy., • Expert in, and genuine care for, expanding access to mental health services and reshaping the future of digital health policy., • Innovative solutions, helping develop and execute strategies that advance our policy priorities., • Critical thinking, with strong analytical skills, capable of deciphering complex legislative and regulatory landscapes to provide actionable insights., • Comfort engaging with elected officials, regulators, corporate executives, and industry leaders - whether in a boardroom or on Capitol Hill., • Ability to advocate for policies in high-stakes environments while maintaining professionalism, diplomacy, and ethical business judgment., • Desire to influence, inform, and inspire, whether drafting policy briefs, advocacy materials, public comments, or speaking at events., • Exceptional written and oral skills, able to translate complex policy concepts into compelling narratives that resonate with diverse audiences., • Outstanding organizational and project management skills, capable of juggling multiple priorities with precision., • Health, Dental, Vision benefits start on your first day at Spring. You and your dependents also receive access to One Medical accounts HSA and FSA plans are also available, with Spring contributing up to $1K for HSAs, depending on your plan type., • Employer sponsored 401(k) match of up to 2% for retirement planning, • A yearly allotment of no cost visits to the Spring Health network of therapists, coaches, and medication management providers for you and your dependents., • We offer competitive paid time off policies including vacation, sick leave and company holidays., • At 6 months tenure with Spring, we offer parental leave of 18 weeks for birthing parents and 16 weeks for non-birthing parents., • Access to Noom, a weight management program—based in psychology, that's tailored to your unique needs and goals., • Access to fertility care support through Carrot, in addition to $4,000 reimbursement for related fertility expenses., • Access to Wellhub, which connects employees to the best options for fitness, mindfulness, nutrition, and sleep in one subscription, • Access to BrightHorizons, which provides sponsored child care, back-up care, and elder care, • Up to $1,000 Professional Development Reimbursement a year. Ready to do the most impactful work of your life? Learn more about our values, what it's like to work here, and how hypergrowth meets impact at Spring Health: Our Values Our privacy policy: Spring Health is proud to be an equal opportunity employer. We do not discriminate in hiring or any employment decision based on race, color, religion, national origin, age, sex, marital status, ancestry, disability, genetic information, veteran status, gender identity or expression, sexual orientation, pregnancy, or other applicable legally protected characteristic. We also consider qualified applicants regardless of criminal histories, consistent with applicable legal requirements. Spring Health is also committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans. If you have a disability or special need that requires accommodation, please let us know.

Job Description Hi, we're Oscar. We're hiring a Manager of Clinical Pharmacy Programs to join our Pharmacy team. Oscar is the first health insurance company built around a full stack technology platform and a focus on serving our members. We started Oscar in 2012 to create the kind of health insurance company we would want for ourselves—one that behaves like a doctor in the family. About the role The Manager, Pharmacy Clinical Programs oversees and manages clinical pharmacy programs driving affordability savings including core formulary management operations. This role partners across Pharmacy, Medical Economics, and the Office of Clinical Affairs to operationalize pharmacy related workflows and monitor existing savings plans for drugs on both the pharmacy and medical benefits. You will report to the Senior Director, Pharmacy Clinical Operations. Work Location: Oscar is a blended work culture where everyone, regardless of work type or location, feels connected to their teammates, our culture and our mission. This is a hybrid role in our Arizona, New York and California office. You will work part of the time in the office and part of the time remote / work-from-home. #LI-Hybrid Pay Transparency: The base pay for this role is: $144,000 - $189,000 per year. You are also eligible for employee benefits, participation in Oscar's unlimited vacation program and annual performance bonuses. Responsibilities • Provide insights and recommendations for trend management and clinical effectiveness, including serving as an important contributor in the enterprise affordability process for pharmacy, • Manage the pipeline of enterprise affordability projects across the pharmacy department (program operations and clinical) and oversee the performance of active programs, • Partner with leads across the organization to communicate, understand and identify upstream and downstream impacts to the business, • Contribute to the design and implementation of clinical programs to improve patient outcomes and reducing costs., • These programs may include medication adherence programs, chronic disease management programs, and patient education efforts, • Operationalize, develop and maintain a clinically appropriate and cost-effective formulary by operating and managing Oscar's P&T committee, which includes evaluating new developments in the drug treatment landscape and providing recommendations on how to manage new to market drugs and new drug indications., • Oversee and improve medical pharmacy preferred drug lists and strategies to supports use of lowest unit cost infusion products, • Provide written recommendations with responses and corresponding documentation for regulatory inquiries, feedback on future legislation, and other business questions that probe at formulary operations., • Accountable and responsible for maintaining mental health parity NQTL responses and working cross-functionally for future filings and responding to ongoing objections during the audit process., • Compliance with all applicable laws and regulations, • Other duties as assignedQualifications, • Doctor of Pharmacy degree (PharmD), • 4+ years working for PBM or Payer in clinical pharmacy operations, • 4+ years leading teams/projects and change managementBonus points, • Residency Training, • 3+ years supporting formulary management (P&T Committee, clinical policy development, formulary run operations) At Oscar, being an Equal Opportunity Employer means more than upholding discrimination-free hiring practices. It means that we cultivate an environment where people can be their most authentic selves and find both belonging and support. We're on a mission to change health care -- an experience made whole by our unique backgrounds and perspectives. Pay Transparency: Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience. Full-time employees are eligible for benefits including: medical, dental, and vision benefits, 11 paid holidays, paid sick time, paid parental leave, 401(k) plan participation, life and disability insurance, and paid wellness time and reimbursements. Reasonable Accommodation: Oscar applicants are considered solely based on their qualifications, without regard to applicant's disability or need for accommodation. Any Oscar applicant who requires reasonable accommodations during the application process should contact the Oscar Benefits Team () to make the need for an accommodation known. Artificial Intelligence (AI) Guidelines: Please see our AI Guidelines for the acceptable use of artificial intelligence during the interview process at Oscar. California Residents: For information about our collection, use, and disclosure of applicants' personal information as well as applicants' rights over their personal information, please see our Notice to Job Applicants.

The Executive Director will direct the development and submission of investigational drug applications, product registration dossiers, supplements, amendments, as well as providing strategic product direction to project teams on interacting and negotiating with regulatory agencies in order to expedi

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the groups own R&D facilities and through strategic partnerships with manufactures from around the world. About the Role The Regulatory Affairs Senior Associate is responsible for managing key regulatory submission activities (e.g., ANDAs and post-approval changes), supporting commercial product lifecycle management, and providing backup to the Director of Regulatory Affairs. The role plays an essential part in ensuring timely, compliant regulatory filings and strategic input for product development, with particular focus on complex generics and combination products. This role also includes supporting GDUFA III-related meeting package preparation. Responsibilities • Compile and submit ANDAs, supplements (CBE/PAS), annual reports, and labeling supplements in compliance with FDA requirements., • Author relevant eCTD sections using company templates and ensure files are properly formatted with bookmarks, hyperlinks, and metadata., • Evaluate proposed product and process changes against current FDA guidance and industry standards. Recommend appropriate filing strategies, timelines, and risk-based approaches for submission planning and execution., • Support regulatory strategy and submissions for complex generics and combination products (e.g., transdermal systems, injectables, drug-device combinations)., • Create and maintain internal templates, trackers, and tools to manage regulatory planning and combination product submissions., • Provide regulatory support for Design History Files (DHFs), ensuring consistency and alignment with FDA expectations for device related documentation., • Prepare formal meeting packages and briefing documents under GDUFA III, including pre-submission and mid-cycle meetings., • Coordinate with internal departments and external partners for documentation collection, timeline management, and regulatory compliance., • Represent Regulatory Affairs in internal cross-functional meetings and external partner calls, as needed., • Lead regulatory activities for post-approval changes including site transfers, analytical method updates, container/closure system changes, and alternative sourcing of materials., • Participate in product development from early-stage formulation to final submission, incorporating FDA feedback and seeking regulatory guidance when appropriate., • Draft, review, and maintain product labeling and promotional labeling, ensuring alignment with current regulations and internal policies., • Review technical documentation and provide regulatory guidance to internal and external stakeholders. Ensure all submissions meet FDA standards, cGMP requirements, and Quality-by-Design (QbD) principles., • Ensure submission documentation is accurate, complete, and in compliance with applicable FDA regulations and company quality standards. Qualifications • Bachelors degree in Pharmacy, Chemistry, Biology, or related field required., • Advanced degree preferred. Required Skills • 5+ years experience in pharmaceutical regulatory affairs., • Experience with complex and combination products and knowledge of FDA expectations., • Experience with eCTD software, MSWord, Excel, Adobe Acrobat and other document processing software., • Independently compiled and filed ANDAs, • Familiar with cGMP requirements., • Sterile products experience Compensation & Benefits At Breckenridge Pharmaceutical, Inc, were committed to investing in every team members total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location: • Flexible approach to how we work, • Health benefits and time-off programs, • Competitive compensation packages, • The anticipated annual salary for this role is $88,000-125,000 Equal Opportunity Statement Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Associate Director/Director, RA-GDP Contractor. Associate Director/Director, RA-GDP Contractor.

Director/Associate Principal – Scientific Strategy Consulting What Is Prescient? We are a specialist strategic partner to global biopharma companies. We provide expertise, derived from our extensive experience, across the drug life cycle. Science, strategy and technology underpin our business, but it’s driven by deep, collaborative relationships. As true thought partners, we are focused on helping clients unlock the full potential of their innovations and improve people’s lives. About Our Medical and Scientific Strategy Practice Our consultancy services are built on deep scientific and medical expertise. It’s a uniquely science-first mentality, in lock-step with the values of our clients. We explore the needs and motivations of the medical community and turn that information into powerful insights that inform our clients’ strategies, with the ultimate goal of shaping the future of healthcare and improving patient outcomes. Our approach integrates rigorous scientific analysis, market understanding and collaborative planning. We challenge the status quo, pushing the boundaries of what’s possible to unlock new opportunities and innovation through strategic thinking. What Will I Do? As a Director/Associate Principal, you will lead high-impact consulting engagements that shape biopharmaceutical asset strategy. You will have three primary responsibilities: Project Delivery: • Lead project teams in delivering actionable insights, • Along with the AVP or VP on the project, manage senior client relationships, ensuring ongoing contact and alignment, • Ensure that medical and scientific perspectives are integrated into broader asset strategies, • Lead complex medical and scientific strategy engagements (e.g., clinical trial strategy, medical affairs planning, early asset strategies), managing the full project lifecycle from scoping to execution, • Oversee multiple projects concurrently, ensuring high-quality execution, • Guide teams in conducting rigorous primary research with clinical experts and other key stakeholders, and secondary scientific analysis (i.e., managing analysis of clinical trial landscapes, treatment algorithms, regulatory pathways, competitive dynamics and more), • Identify and lead on opportunities for new consulting engagements within both new and existing client accounts, • Author compelling proposals and presentations to win new business, • Contribute to compelling thought leadership (e.g., white papers, conference presentations, industry publications), • Lead and mentor a team of consultants and engagement managers on projects through direct line management, • Build professional development plans and provide coaching for your direct reports, • Resolve interpersonal conflicts when they may arise, whether on project teams or in other contexts, • Contribute to internal training initiatives, helping to build capabilities across the Medical and Scientific Strategy practice, • Lead an internal initiative that contributes to the success of the team (e.g., recruitment, culture, knowledge management) What Skills and Experience Do I Need to be Successful for this Role? Required: • A broad understanding of the biopharmaceutical industry, and a commitment to remain up to date on the latest developments and trends from both a scientific and a business perspective, • A minimum of six years of consulting experience within the biopharmaceutical industry, with proven ability to lead large strategic consulting engagements with a focus on asset strategy and portfolio strategy for commercial, medical affairs or clinical development clients, • Demonstrable experience at the engagement manager level within a comparable consulting organization, • A Bachelor’s degree in a relevant life sciences area, or significant scientific-focused experience of early and late-stage drug development, • Experience of managing teams and mentoring junior consultants in a fast-paced, dynamic environment, • An advanced degree in life sciences (i.e., PhD, MD, PharmD), • A deep understanding of oncology, hematology, and/or rare diseases, • Familiarity with different ways of working across commercial, medical affairs and clinical development, • Direct experience of delivering projects with medical affairs clients, • Experience in process improvement and optimization, organizational efficiency and effectiveness, • Experience in real-world evidence (RWE), • Experience working in the pharmaceutical industry Why Choose Prescient? What Makes Us Special? Founded in 2007, Prescient is a global firm with a footprint in ten cities across three continents. Our team of nearly 400 experts partners with 27 of the top 30 biopharmaceutical companies, the fastest-growing mid-caps, and cutting-edge emerging biotechs, including some of the biggest and most innovative brands. More than 70% of our employees hold advanced life sciences degrees, and our teams deliver an impressive depth of therapeutic, clinical and commercial expertise. We foster a high performing, collaborative and entrepreneurial culture, offering structured Learning & Development, specialized training and mentorship. Prescient also offers a comprehensive benefits package, including 401K matching, comprehensive health and dental benefits, generous PTO, and flexible working arrangements. Prescient has been a portfolio company of Bridgepoint Development Capital since 2021 and Baird Capital since 2017. For more information, please visit: . We are an equal opportunity employer and fully comply with applicable legislation in all the geographies in which we operate. Applicants are considered for positions without regard to veteran status, uniformed service member status, race, color, religion, sex, national origin, age, physical or mental disability, genetic information, or any other category protected by applicable national, federal, state, or local laws.

Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals. Edit or manage the editing of scientific sections of regulatory documentation against the regulatory requirements. Supervisory responsibility for the planning, preparation and submission o

Our teams include Communications, Community Impact and Investment, Community Finance, CRA Strategy and Program Management, the Government and Political Affairs Group, Regulatory Relations, and Strategy and Engagement. As a Director, you will serve as a strategic people leader within Community Financ

Job DescriptionCompany Description EVERSANA has partnered with Mitsubishi Tanabe Pharma America, Inc. for this Direct Hire opportunity. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson’s (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology. MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare disease treatments including RADICAVA® (edaravone) injectables in 2017 and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness. Job Description Direct Hire Opportunity! The Senior Director, Trade & Distribution, will build, lead, and manage the team while focusing on developing strategies to support the launch and lifecycle management of our leading Parkinson's and ALS therapies, as well as future products in the United States. The primary responsibility of the Senior Director Trade & Distribution is to develop and implement the distribution strategies across the specialty businesses. This includes specialty pharmacies, distributors and all channels that would support any present or future MTPA products. This person will have an intimate knowledge of the distribution systems from all aspects including durable medical equipment. The ideal candidate will possess strong leadership experience in managing teams that work both directly and indirectly with specialty vendors, coupled with exceptional analytical skills to identify operational gaps and implement effective solutions. Cross-functional collaboration with supply chain, marketing, sales, and customer-facing teams will be key to success in this role. Responsibilities • Provides overall leadership and direction for Trade Market Access strategy for Mitsubishi Tanabe Pharma US’ lead Parkinson and ALS products, • Evolve and innovate distribution network by aligning it with business needs, identifying growth opportunities, and addressing operational gaps to overcome challenges and drive access. Serves as the Distribution and Trade Strategy Team Leader, representing, • trade across all teams and driving key success factors to support long-term distribution strategies. Lead the development and execution in Federal Markets, including VA and Department of Defense to drive product access, distribution, and growth. Act as subject, • matter expert from a Market Access perspective for 340B program and other government programs., • Informs senior and corporate executives informed about changes and emerging issues in the broad, trade customer environments and subsequent implications for Mitsubishi Tanabe Pharma US, • Develops awareness of market and government policy changes in collaboration with legal and compliance and implications across key stakeholders to help inform/update commercial strategies, • Assists market access marketing agency (and other vendor relationships) to develop promotional programs, tactics and materials aligned with our distribution process, • Develops/maintains thorough understanding of dynamics driving various market access segments and channels and how distribution impacts each function, • Effectively manages budgets and project timelines including contract management, • Oversight in the negotiation, execution, and adherence to the Distribution Service Agreements (DSAs), Product Purchase Agreements, and other contract offerings as appropriate, • Develop account metrics against strategic, financial, and product access KPI’s, • Develops and monitors KPIs, continually assessing impact and execution of access services & offerings including feedback from service users and internal stakeholders, • Attends professional, provider programs, and patient conferences, and keeps up to date on innovation and recommends ways to improve business., • This is a home office based position. The expectation is to be in the office 3 days a week. #LI-CG1 Qualifications • Bachelor’s Degree Required, Masters preferred, • Must have 15 plus years within the pharmaceutical industry and 10 years’ experience in Distribution, Account Management or Aligned Market Access functions., • Experience with distribution for early-stage pipeline programs, • Experience in Federal Markets including VA, Department of Defense and 340B Program preferred., • Device/Drug combination strongly preferred, • Minimum 5 years of people management experience required, • Track record of closing complex negotiations within the specialty pharmacy arena, • Preferred experience includes:, • All aspects of distribution, • Launch and life cycle management for the distribution process, • Experience in Market Access marketing, • History of successful negotiations, • Broad based knowledge of the Pharma/Biotech industry, healthcare finance, and all forms of product distribution: DME, Orals, and Solutions, • Firm grasp of legal, regulatory and compliance issues in the healthcare space, • Analytical/strategic thinker with proven ability to:, • conduct situation analysis of the external distribution environment; synthesize relevant information to develop strategic plans, • understand the best pathway for distribution based on the product and its attributes, • conduct strategic gap analysis and implement metric-based solutions, • Strong interpersonal and internal/external relationship-building skills in order to drive change and innovation and succeed in a highly specialized distribution environment, • Excellent oral/written communication skills, coupled with exceptional presentation skills, including ability to present to large audiences, • Ability to prioritize and manage complex projects, with multiple stakeholders, and drive high-quality results within allotted budget, • Highly proficient in MS Office; advanced Excel skills, • Must be able to travel domestically and internationally (approximately 40%) Additional Information Mitsubishi Tanabe Pharma America Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits. MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date. The salary range for this position is $210,000 - $280,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

Job Description Position Summary: Avyxa Pharma, a leading manufacturer of 505(b)(2) oncology products, is seeking an experienced and driven Director of Sales to lead our sales efforts in the eastern and western United States. These individuals will be responsible for managing a team of sales professionals, driving business growth, and developing strategic relationships with key stakeholders in the oncology space while maintaining a competitive and positive work culture. The ideal candidate will have pharmaceutical sales experience, with a strong background in oncology and 505(b)(2) drug commercialization. This role requires up to 70% travel and reports to the Vice President of Sales & Corporate Accounts. Key Responsibilities: · Following company strategic goals and philosophy, the Director of Sales will provide sales leadership and guide strategic direction for direct reports in assigned territory. · Lead and mentor a team of sales professionals, setting performance objectives and ensuring successful execution as evidenced by quarterly goal attainment for all qualified Avyxa products. · Will work independently and with direct reports to identify and develop new business opportunities to drive market penetration and revenue growth, endeavoring to maintain strong customer relationships over an extended period. • Team Management & Development:, • Recruit, train, and develop a high-performing sales team that will have responsibility for selling Avyxa’s products, including but not limited to Docivyx®, Frindovyx™, Posfrea™, and Axtle™., • Conduct regular performance reviews, provide coaching, and support career development., • Foster a collaborative, results-driven culture within the sales organization., • Customer Engagement & Relationship Management:, • Build and maintain strong relationships with customers including but not limited to oncologists, pharmacists, nurses, key business personnel, aggregator and group purchasing organizations (GPOs) sales representatives., • Work closely with direct reports to ensure customer needs are met and growth opportunities are maximized by maintaining close relationships with customers, providing Avyxa product contract updates, Avyxa support materials, and ensuring productive collaboration between customers and other internal Avyxa resources, (market access, field reimbursement, payer team, operations) • Represent Avyxa Pharma at industry conferences, advisory boards, and networking events. Data-Driven Decision Making: • Utilize Tableau, Excel, and other analytics tools to track sales performance and market trends., • Prepare and present sales reports, forecasts, and business reviews for senior leadership., • Communicate and leverage market intelligence to adjust strategies and optimize sales efforts., • Cross-Functional Collaboration:, • Partner with Avyxa Strategic Account Directors, Data and Analytics, Field Reimbursement Team, Operations Team and Medical Affairs to ensure effective product positioning and messaging., • Provide customer insights to support product development and commercialization efforts., • Ensure compliance with pharmaceutical regulations and corporate policies. Qualifications & Experience: • 8+years of pharmaceutical sales experience, with at least 3 years in oncology. Managerial experience preferred. Candidates with similar experience and exceptional track record of success will be considered., • Strong understanding of the 505(b)(2) regulatory pathway and drug commercialization in community oncology and hospital/IDN setting preferred., • Proven leadership experience, with a track record of managing and developing sales teams., • Excellent verbal and written communication skills., • High proficiency in PowerPoint, Excel, Tableau, and other sales analytics tools., • Ability to travel up to 70% across the designated region. Preferred Qualifications: • Experience working with community oncology practices, hospitals, and integrated delivery networks (IDNs)., • Sales management · Understanding of the buy-and-bill oncology reimbursement methodology, GPO and aggregator relationships. • Prior experience launching 505(b)(2) oncology drugs. Location: Remote (Must reside within the designated region) Compensation & Benefits: Competitive salary, performance-based bonus, comprehensive benefits package, and travel reimbursement. Company DescriptionAvyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system. Our core values are grounded in providing access to meaningful products that improve patient care.Avyxa Pharma is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system.\r\n\r\nOur core values are grounded in providing access to meaningful products that improve patient care.

The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory/business objectives. E

Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory aspects of Eisai’s products under development and post approval research, including the development of regulatory strategies to ensure effective achievement of regulatory/busines

Directs data entry related activities such as patient admission, regulatory reporting, billing, physician orders, lab results, vital signs, patient status and any other treatment related data into systems. Ensures regulatory, compliance, and audit activities are accomplished on time.

Manhatta is a restaurant from Danny Meyer’s Union Square Hospitality Group, combining sky-high views with down-to-earth hospitality.Perched sixty stories above Lower Manhattan, Manhatta offers stunning views of New York City, its bridges, and waterways.The Event Operations Manager is responsible f

Executive Director, Credit Risk-Hedge Funds & Asset Managers - New York Country: United States of America Your Journey Starts Here: Santander is a global leader and innovator in the financial services industry.

As a Director of Operations for Boka Restaurant Group, you will oversee specific restaurant locations. Director of Operation's Responsibilities:. As the Director of Operations, you will be assigned an entity and goals at that entity in any of the following circumstances (Note: additional reasons may

GMs, chefs, bar directors, and ownership.

Regional Director of Operations.

At The Knot Worldwide, we champion celebration - and that starts with celebrating our people.Our employees are passionate dreamers, thoughtful doers, and lifelong learners who power meaningful moments for millions around the world.We’re united by authentic connection, shared purpose, and a deep co

Swingers – the crazy golf club.We offer excellent benefits and compensation of.Competitive Salaries with ample room for career growth.Three different medical plans to suit you and your family’s needs, plus dental and vision options .Free Telemedicine services through Healthjoy.Voluntar