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Title: Validation SME Duration: 5+ months contract (candidates who are willing to be converted to FTE/Perm upon completion of contract will be moved to stop of the list) Location: Hybrid onsite 3 days in Long Island City, NY (11101) Must Have: • Extensive experience within medical, pharmaceutical, or regulatory compliance environments, • Strong Computer Software Assurance (CSA) expertise; able to serve as the subject matter expert, • Excellent communication, leadership, and collaboration skills; positive and approachable demeanor, • Agile methodology knowledge/experience strongly preferred Responsibilities: • Provide subject matter expertise on validation project risk and complexity, • Ensure adherence to validation best practices and compliance standards, • Gather project information and requirements from system stakeholders, • Collaborate frequently with Business Analysts and cross-functional teams, • Maintain compliance with Good Documentation Practices (GDP), • Support authoring and reviewing of validation reports and documentation, • Collect and integrate feedback from system stakeholders on deliverables, • Draft and execute GxP Assessments, Risk Assessments, Validation Plans, Test Plans, and Validation Summary Reports as needed, • Review, draft, and execute additional validation documentation when required Qualifications: • Bachelor’s degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or a related field, • 7–10+ years of progressive experience in Computer System Validation (CSV) and Computer Software Assurance (CSA), • Solid knowledge of GAMP 5 and 21 CFR Part 11 standards, • Prior experience in GxP or life sciences industries required, • Strong understanding of FDA regulations and compliance requirements, • Proven experience creating, reviewing, and resolving CAPAs, • Ability to work independently while meeting project deadlines, • Practical knowledge of Data Integrity and ALCOA+ principles is a plus Competencies: • Technical Competency: Able to translate business requirements into CSV documentation and supporting materials, • Time Management: Manages strict deadlines and competing priorities effectively, • Analytical Skills: Applies logical reasoning to identify, research, and communicate critical information, • Agility: Adapts to shifting priorities and timelines while maintaining high-quality deliverables, • Commitment to Quality: Demonstrates strong understanding of CSA, prioritizing customer safety, data integrity, and product quality Note: This opportunity is not open to C2C arrangements.

Job Description Faro Health aims to improve lives by helping life sciences companies answer complex clinical questions, simply, efficiently and effectively. Our software platform is used to orchestrate complex clinical development with a single source of truth. It brings words, data and teams together, empowering researchers to design more intelligent trials, master complexity and reach milestones faster. The Clinical Strategy and Solutions Specialist will support all aspects of study modeling within the Faro Study Designer to ensure quality of studies modeled supporting the success of our users and supports the enhancement of data-driven features on the Faro Health Platform. In this role, you will utilize your expertise in Clinical Operations to understand and reflect clinical protocols in the Faro Health Platform across a variety of Therapeutic Areas and Study Designs. This role will also support the development of training materials and other tasks that may require clinical expertise. This position is 100% remote and only open to candidates who currently reside in one of the following states: California, Wisconsin, North Carolina, Massachusetts or New York only. Requirements Duties and Responsibilities • Conduct modeling of publicly available studies in the Faro Study Designer for customers, sales demos and continuous buildout of the public study library, • Conduct clinical QC of public study library modeled studies, • Conduct QC of Clinical Data Management gap assessments of public studies for customer, sales demo, and public study library modeled studies, • Work with the Product Experience (PX) team to support the development of training materials that may require clinical expertise, • Support other tasks as needed, • Ability to work 30-40 hours per week, • Ability to work during the hours of 9am to 3pm Pacific Time Qualifications • Bachelor’s degree required, preferably in physical or life science or statistics discipline, • 5+ years of Clinical Operations work experience in pharmaceutical clinical trials, • Experience as a Clinical Research Associate, • Oncology experience or complex clinical trial experience, • Experience with Phase I and Phase II studies, • Strong knowledge of clinical trials and drug development processes, • Ability to read and comprehend complex clinical trial protocols and designs, • Familiarity with and experience using clinical trial technologies (e.g., EDC, IRT, CTMS, ePRO, eCOA, eConsent, TMF), • Knowledge of regulatory requirements and information governance frameworks (e.g. ICH, GCP, HIPAA, GDPR), • Excellent team player with demonstrated track record of success in a cross-functional team environment; consistent commitment to delivering on team goals with a sense of shared urgency Skills and Competencies • Strong organizational, motivational, and leadership skills, promoting a team-based approach, • Strong attention to detail skills and ability to triage and aid in resolution of escalations, • Ability to work independently or in a group setting; ability to adjust to changing priorities, • Strong emotional intelligence, interpersonal and communication skills, both verbal and written, • Strong organizational and leadership skills, • Strong problem solving skills, • Goal-oriented, • Ability to project and maintain a professional and positive attitude Salary • This is a 5 month contract with possibility for extension, • Hourly range for this position is $50 to $60 per hour. Individual hourly pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training., • Open to candidates who currently reside in California, Wisconsin, North Carolina, Massachusetts or New York only.

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, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: Compass is seeking a highly motivated and experienced Director, Regulatory Project Management to lead the end-to-end project management of a New Drug Application (NDA) submission. This individual will ensure that all activities are strategically planned, efficiently executed, and delivered on time, within scope, and to the highest quality standards. Location: Hybrid in our New York City office or remote on the East Coast, USA. Reports to: Senior Vice President, Regulatory Affairs. Duration: 12 months contract. Roles and responsibilities (Include but are not limited to): Submission Leadership • Develop, implement, and maintain a comprehensive NDA submission project plan, including detailed timelines, workstreams, milestones, and dependencies, • Drive the overall project plan for NDA preparation and submission, ensuring all components are planned, tracked, and delivered on schedule, • Define the critical path activities and proactively adjust plans in response to evolving requirements or risks, • Align submission activities with overall development program strategy and corporate objectives, • Partner with Regulatory Strategy and Operations leads to translate high-level regulatory strategy into detailed, executable submission plans Governance & Oversight • Establish appropriate submission governance forums (e.g., core team, functional sub-teams, steering committee, etc.), • Define decision-making process and escalation pathways to ensure effective risk and issue management, • Facilitate effective cross-functional working sessions to maintain alignment and momentum, • Provide regular status updates, metrics, and dashboards to cross-functional teams, management and executive leadership Execution & Deliverable Management • Drive collaboration across Clinical, CMC, Nonclinical, Clinical Pharmacology, Safety, Statistics, and Medical Writing, to ensure alignment of deliverables, • Track document authoring, review, and finalization cycles, providing clear visibility of status across teams, to ensure CTD content is delivered on schedule, • Partner with regulatory operations to oversee dossier compilation, QC, and submission readiness, • Serve as the central point of contact for submission progress and status inquiries Risk, Issue & Change Management • Proactively identify risks to submission timelines and establish mitigation and contingency plans, • Maintain a risk register and ensure issues are tracked, escalated, and resolved in a timely manner, • Manage changes in priorities or scope while preserving overall submission objectives Operational Excellence • Develop and maintain detailed timelines, trackers, and dashboards to drive execution against critical path activities, • Support Regulatory Operations efforts in publishing, document management, and inspection readiness with internal teams and external vendors, • Ensure adherence to SOPs while introducing pragmatic process improvements where gaps exist, • Develop, maintain, and monitor detailed submission project plans, including critical path analyses and contingency planning, • Ensure adherence to company standard operating procedures (SOPs), templates, and regulatory publishing requirements, • Support inspection readiness and documentation of submission-related activities Health Authority Engagement • Develop and oversee project plans and timelines for FDA interactions related to the NDA submission, including briefing packages, meeting logistics, and response management, • Ensure all submission components meet regulatory agency requirements and withstand internal/external audit scrutiny Post-Submission Transition • Establish mechanisms to track submission-related milestones, commitments, and queries from FDA (e.g., Labeling, REMS, IRs, etc.), • Develop and oversee response authoring timelines for FDA submission-related queries, • Transition governance from submission execution to lifecycle management and post-approval commitments Candidate profile: • Bachelor's degree in life sciences, pharmacy, or related discipline required; advanced degree (MS, PharmD, PhD, or MBA) preferred, • 10+ years of experience in the pharmaceutical/biotech industry, with significant experience in regulatory project management, • Demonstrated leadership in managing at least one NDA or BLA submission from initiation through completion; experience managing rolling and/or expedited reviews is a plus, • Deep knowledge of FDA regulations, ICH guidelines, and CTD/eCTD structure, • Proven ability to manage complex, multi-disciplinary projects under tight timelines, • Proficiency with project management methodologies and tools (e.g., MS Project, Smartsheet, Veeva Vault RIM, or equivalent), • Strong organizational, analytical, and facilitation skills, with an ability to influence across functions and levels 【For NYC】Compensation Description (annually): 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】:$225,000—$275,000 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 DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Eurofins Transplant Genomics Inc. (“ETG”) is a molecular diagnostics company committed to improving organ transplant outcomes with non-invasive serial monitoring guided by biomarkers. ETG’s product portfolio of both individual and combined whole blood gene expression and donor derived cell-free DNA testing is capable of reliably ruling out subclinical kidney rejection and acute rejection in kidney transplant patients. In addition to kidney transplantation testing, our newest product for liver transplant patients is a blood-based biomarker assay designed to rule out rejection as immunosuppression therapy is optimized. Basic Function and Scope of Responsibility: The Territory Manager – (TM) is the account “lead” and is primarily responsible for; 1) generating account demand for ETG product offerings with new customers, 2) coordinating and facilitating product adoption and growth, 3) onboarding and educating on ordering process and sample collection, and 4) ultimately assuring a positive customer experience by demonstrating and delivering the Value Proposition(s) of the ETG product portfolio through our clinical, provider, patient, and practice management support systems and resources. The Territory Manager will support the financial objectives of the assigned territory by effectively implementing Transplant Genomics’ sales and marketing strategies to grow product portfolio volume and revenue. The Territory Manager is expected to be in-field client facing personnel supporting all commercial company endeavors. Qualifications • Bachelor’s degree required, preferably in a science or business-related field of study., • At least 5 years of successful direct sales and business development experience in the academic hospital setting responsible for all aspects of the sales process, with a strong preference for previous solid organ transplant, hepatology, dialysis, or laboratory experience required, • Ability to travel up to 50%, • Customer service focused and professional attitude, • Self-starter who takes control of all account sales processes and solves problems, prioritizes tasks, and mobilizes resources to achieve sales objectives, • Goal oriented with excellent time management, prioritization, and organizational skills and disciplines., • Excellent interpersonal skills with ability to interact effectively and work efficiently with people at all levels in an organization, • Excellent verbal & written communication skills, • Keenly attentive to detail, • Ability to keep sensitive information confidential Additional Information Schedule: • Excellent full time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job Description Welcome! Ovid Therapeutics is a biopharmaceutical company developing medicines designed to conquer seizures with courageous science. We exist to serve and meaningfully improve the lives of people affected by epilepsies and brain disorders with seizure symptoms. It is with curiosity, courage, and tenacity that, together, we work for meaningful change in the lives of patients and their families. With this sense of purpose and urgency we challenge the conventional and embrace the wisdom and thought that comes from diverse backgrounds and perspectives. Importantly, we understand the commitment we make to our patients, our broad community and to each other is based on the humanity that we share. The Role On Our Team We are seeking an experienced formulation development and process development scientist in the New York City, Philadelphia, or Boston area for a new and uniquely broad role spanning from formulation discovery to pharmaceutical development, to deliver multiple drug product options for CMC manufacture. Working across functional groups, the Director will be responsible for providing leadership and decisions on small molecule drug products from drug discovery to clinical studies. As the lab functions are completely outsourced, strong communication and interpersonal skills are needed to direct work done in CROs and CDMOs in remote locations often in different time zones. Broad technical expertise and leadership in formulations, process development, and CMC will be critical to the success of the role. Reporting to the CSO, this is a highly visible and team-facing role. The role is a hybrid of office visits in NYC a few times a month, working from home, and meeting with other colleagues in local workshare locations. Job Responsibilities: • Serve as a senior member of the R&D Team responsible for developing and establishing small molecule strategies, • Provide leadership and direction for the area of formulations, process development, and clinical CMC for small molecule formulations including oral solid dosage forms and sterile injectables, • Provide leadership and hands-on technical, operational, and strategic guidance on a wide range of activities across all development stages from lead optimization of pre-clinical drug candidates, pre-formulation, formulation development, process scale-up, technology transfer, and process validation of clinical drug candidates, • Demonstrate a thorough understanding of the cGMP environment (internal and external cGMP manufacturing operations) and compliance requirements and provide technical support to internal and external cGMP manufacturing operations, • Ensure successful transfer of new products and technology to internal and external clinical and commercial manufacturing sites, including generation of knowledge and understanding to support product robustness targets, • Liaison with internal and external stakeholders to ensure there is accurate levels of finished goods material availability per demand management requirements to reduce obsolescence, minimize expired items and maximize inventory turns, • Provide guidance and strategic directions through interactions with each project team. Work across functional groups in Research, Regulatory and external partners identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise, • Minimum of BS in a related field with 10+ years of relevant process development, formulations, and CMC of pharmaceutical products and supporting CMC clinical programs, • Small molecule experience in drug discovery teams, • Demonstrated experience for leading early-stage pharmaceutical development functions Your Background and Experience - preferred qualifications • MS with 8+ years or PhD with 6+ years of relevant experience. Advanced degree in chemical engineering or chemistry or pharmaceutical development, • Experiences designing and optimizing drug formulations, conducting stability studies, analyzing data, preparing technical reports for regulatory submissions, and collaborating with cross-functional teams, • Have experience in the production of small molecules (API and drug product) from planning through procurement; technical transfers, qualification, validation, trouble shooting, NDA’s, FDA inspections, process scale-up, and commercial operations support, • Experience with managing contract manufacturing organizations and be familiar with supply chain architectures including vendor selection, qualification, and contracting, • Have outstanding written and verbal communication, including listening, presentation, and conveying technical information for a broad audience., • Bring a history of great collaboration and teamwork with the ability to motivate and influence others; have a reputation for successful partnering with internal and external stakeholders, • Have the ability and the drive to succeed in a small biotech organization. Interest to grow in the function to advance new technologies in new therapies. Must be self-motivated, proactive, work well under pressure and deadlines, and thrive in a small “all hands-on deck” environment, • Solution-oriented thinker who possesses a “can do” attitude with a strong sense of urgency, • Have strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best path forward in the face of competing points of view, • Create a balance of analytical and methodical problem solving with creative and flexible solutions We operates in a hybrid-work model. Candidates applying must be willing and able to be in the NYC office in coordination with their manager's expectations, as well as department and business needs. The base salary range for this position is $220,000 - $270,000. The actual salary offered within the range is dependent on a variety of factors including, but not limited to , relevant experience, qualifications, skills, level offered, and performance expectations. Powered by JazzHR hrLf0XvG9T

Job Description Director/Sr. Director of Drug Product CMC Location: New York City, NY Company Overview: We are partnered with a dynamic clinical-stage biotechnology company focused on developing innovative therapies to address unmet medical needs. They are dedicated to advancing science and improving patient outcomes across several treatments and therapies. Their portfolio consists of assets across early and late stage development. Job Summary: The Director/Sr. Director of Drug Product CMC will lead and oversees drug product development, manufacturing, and regulatory activities to ensure high-quality products are delivered from early development through commercialization. This role involves cross-functional collaboration to support product lifecycle management, process optimization, and regulatory compliance for drug products, ensuring all CMC strategies align with company goals and regulatory standards. The Director/Sr. Director will provide technical and strategic leadership, working closely with internal teams and external partners to meet critical project milestones. Key Responsibilities: • Lead the development and implementation of CMC strategies for drug product development and manufacturing., • Oversee technology transfer to and from contract manufacturing organizations (CMOs) and provide technical oversight of drug product manufacturing., • Ensure compliance with cGMP regulations and manage quality assurance activities, including deviation management, batch record reviews, and lot disposition., • Develop and manage risk-based strategies for CMO oversight, considering product lifecycle, technical complexity, and CMO capabilities., • Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, Clinical Development, and Supply Chain, to ensure timely delivery of drug products., • Support regulatory submissions by providing CMC-related documentation and expertise., • Lead process optimization, validation, and continuous improvement initiatives., • Manage the drug product manufacturing budget and long-range planning., • Serve as a subject matter expert during regulatory inspections and audits. Qualifications: • Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field, with 10+ years of experience in CMC and drug product development (or equivalent industry experience for those with a Ph.D.)., • Strong knowledge of cGMP regulations, ICH guidelines, and CMC content of regulatory submissions., • Proven track record in CMC regulatory submissions (IND, IMPD, NDA), • Experience managing CMOs and overseeing technology transfer processes., • Excellent problem-solving, project management, and communication skills., • Ability to work collaboratively in a fast-paced, dynamic environment., • Familiarity with quality-by-design (QbD) principles, statistical analysis, and DOE., • Willingness to travel as needed (up to 10%). What We Offer: • Opportunity to lead in a dynamic, fast-growing company with a strong pipeline of innovative therapies., • Collaborative work environment with professional development and career growth opportunities.

Job DescriptionCompany Description • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices., • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Responsibilities: • Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s)., • Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets., • Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements., • Provides input in the design and development of case report forms and clinical databases., • Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs., • Programs for quality checks for clinical study raw data and report the findings to Data Management., • Provides input in the design and development of case report forms and clinical study databases., • MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years., • Experience in providing statistical programming support to early and late phase clinical trials., • Excellent skills in SAS programming and statistical reporting., • Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements., • Familiarity with FDA and ICH regulations and guidelines., • Excellent problem-solving skills., • Good written and verbal communication skills and organizational and documentation skills., • Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc., • Ability to prioritize and multi-task effectively., • Demonstrated positive attitude and the ability to work well with others.Additional Information All your information will be kept confidential according to EEO guidelines.

Job Description Reporting directly to the CEO, the Marketing Manager is responsible for all marketing and partnership development activities to support the strategic direction of Manhattan Restorative Health Sciences (MRHS). They will be responsible for supporting a patient-centric work environment, in alignment with MRHS’ core values: Inspiration, Purpose, Professionalism, Collaboration, and Innovation. Responsibilities: Marketing: • Develop an annual marketing plan for MRHS with clearly defined goals and a plan for execution, • Collaborate with leadership to identify and execute strategic initiatives utilizing the standard business cases and project charters, • Oversee the overall branding and public relations function for MRHS, • Maintain a Brand Center for MRHS and audit collateral to ensure compliance for branding and messaging (print and electronic media), • Maintain editorial calendars, • Lead patient experience initiatives and report to the CEO and or other stakeholders as required, • Support a culture of service excellence by triaging high priority patient concerns while investigating the causes and providing an immediate solution(s), • With input from the leadership team, develop a quarterly business development plan, • Identify and prospect potential business development/partnerships opportunities, • Evaluate business deals to include projected value, prepare presentations and briefing books, • Collaborate with key stakeholders to structure the negotiations and contracts, • Maintain and monitor the business development pipeline, • Collaborate with other department leads to implement and track “new patients referral seen”, • Represent MRHS at events to explore new business development e.g., Trade Shows, Conferences, Corporate Events, Membership Associations, etc., • Maintain relationships with key vendors and pharmaceutical representatives, • Administrative oversight for the Marketing function and all its direct reports, • Participate in the hiring and onboarding of staff as needed across the organization, • Conduct training and performance appraisals for direct reports, • 4 - 8 years of experience in the marketing field, including leading the execution of an end to end marketing program, • Undergraduate degree in a related field, • Graduate degree preferred; but not required All qualified applicants will receive consideration for employment without regard to age, sex, sexual orientation, gender identity, national origin, race, color, religion, disability, or protected veteran status, or any other legally protected basis, following applicable laws. For more information, visit MRHSclinics.com Company DescriptionOur team of world class, award-winning physicians and specialists are driven to develop innovative 'body and mind' treatment plans for our patients, and to advance impactful medical research for all.Our team of world class, award-winning physicians and specialists are driven to develop innovative 'body and mind' treatment plans for our patients, and to advance impactful medical research for all.

Job DescriptionWe are looking for a skilled Procurement Specialist to join our team in New York, New York, on a long-term contract basis. This role is ideal for professionals with a passion for managing procurement operations and building strong vendor relationships. You will play a key part in ensuring timely and compliant purchasing processes while contributing to continuous improvement initiatives. Responsibilities: • Manage the full lifecycle of procurement activities, from sourcing to delivery., • Create, execute, and monitor purchase orders and change orders, ensuring proper documentation and adherence to deadlines., • Collaborate closely with internal teams, such as R& D and Finance, to align procurement strategies with project goals and budgets., • Maintain and oversee vendor records and procurement documentation within systems like NetSuite and Zip., • Ensure strict compliance with internal policies, procedures, and regulatory standards., • Identify opportunities to improve procurement workflows and implement process enhancements., • Conduct supplier evaluations and maintain qualification documentation as needed., • Support contract negotiations to secure favorable terms and conditions., • Provide timely reports and analysis on procurement activities to stakeholders.• 2–4 years of experience in procurement or purchasing, ideally within the biotech, pharmaceutical, or life sciences industries., • Solid understanding of procurement workflows and systems such as NetSuite, Oracle, or similar platforms., • Strong communication skills with the ability to foster productive vendor and stakeholder relationships., • Exceptional attention to detail and proficiency in organizational and analytical tasks., • Familiarity with supplier qualification procedures and documentation standards., • Certification in procurement or supply chain management is a plus., • Experience working with early-stage or growth-stage biotech companies is preferred.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert (SME) and Project Manager in the execution of Cresilon’s Preclinical Research Operations, including but not limited to in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy. This will include the development and execution of strategies for preclinical evidence necessary to competitively position a project’s product for domestic and international regulatory and clinical acceptance. This position as a hybrid role, with work off-site at CRO in NY/NJ area, work from home and on-site at Brooklyn NY. Job Responsibilities: The Preclinical Research Scientist will: • Lead, staff, and manage Cresilon’s Preclinical Research activities., • Provide preclinical scientific input and leadership on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life cycle., • Plan, direct, coordinate and execute activities related to the design, initiation and follow-up of studies to support approval of Class I-III medical devices., • Develop, write, and/or review study protocols and reports. Act as technical mentor for the development of study experimental designs, protocols, and reports of junior associates., • Administrate and manage Cresilon preclinical regulatory strategy and communication., • Work with Contract Research Organizations (CROs) to execute both Biocompatibility / Safety and Efficacy/Functionality research, including negotiating, drafting, and managing research contracts and agreements with pre-clinical trial sites., • Ensure that company operates within the scope of regulatory compliance including Quality System Regulations (ISO 13485), health and safety, environmental protection regulations, and the core values of Cresilon., • Be a Subject Matter Expert (SME) for preclinical research department growth strategy. Actively interact with the internal and external scientific community to maintain state of the art knowledge., • Oversee the development of and modifications to preclinical models to address project needs., • Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines., • Surveys the literature to identify and compare competitive product performance and safety risks., • Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP's, company policies, etc), • Work cross functionally with Regulatory and Quality to assess project risks, product safety and efficacy on NPD projects, including ensuring external facilities meet Cresilon standards for animal use and generating contracts and CRO audits, if necessary., • Manage budgetary requirements for all research projects to support efficacy and safety programs., • Lead the effort to publish surgical research in peer-reviewed journals., • Regularly interface with management to ensure research operations reflect overall corporate vision/strategy., • DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field is required., • Minimum 6+ years’ experience in preclinical medical device research is required, preference given to veterinary surgical or human surgical experience., • 4+ years of people management experience preferred., • Extensive knowledge of surgery, anatomy, toxicology, and pathology is required., • Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred., • Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred., • Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations., • Experience with surgical publication submission strategy is strongly preferred., • Strong communication skills (both written and verbal) is required with the ability to extract key facts from complex information and present concise summaries to management., • Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required., • Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred., • Excellent problem solving, conflict resolution, and analytical skills is required., • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment is required., • Prior experience and ability to work well with external CROs and collaborators with professionalism and discretion is required., • Requires strong leadership and organizational skills including attention to detail and multi-tasking skills., • Able to understand and execute to project details but keep overall “big picture” view of projects, priorities, and strategies is required., • Medical Device product development experience, including knowledge of medical device regulations, regulatory/notified body requirements is preferred., • Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP), • Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is preferred., • Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred., • Legal authorization to work in the United States., • This position is located in Brooklyn, NY and may require up to 30% travel (to monitor and execute out-sourced studies) Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $130,000 - $210,000, depending upon job level and qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Electrical Factory Inspector (Remote/Travel) responsibilities include, but are not limited to, the following: • Support department objectives and company goals, • Be a team player, • Sustain a positive, enthusiastic and professional attitude at all times, • Accommodate requests with a smile and “let me see what I can do” attitude, • Adhere to manager directives, • Maintain a professional appearance and demeanor, • Arrive on time, properly dressed and prepared to work, • Perform all duties in a timely, accurate, honest and professional manner, • Communicate with customers professionally and in accordance with customer service standards, • Surveillance inspections of factories to assure products remain in compliance with conditions of granted certification., • Other duties assigned by management.Qualifications Basic Minimum Education Qualifications: • Knowledge of electronics, • Certification in Electronics, • Willing to travel - This position requires 90% - 100% travel, • Add requirement to be able to rent a car (Minimum age of 25), • Willing to work overtime and remote, • Cannot be on any no fly list, • Clean driver record, • Ability to maintain confidentially, • Needs to be receptive to and accepting guidance from others, • Ability to deal with difficult people and problems, • Able to work well in a team environment, • Able to work in a diverse group of people, • Attention to detail, • Ability to multi-task and prioritize assignments, • Able to sit or stand for long periods of time, • Able to lift up to 30 pounds Additional Information Position is full-time travel & hybrid, working Monday - Friday 8:00 am to 5:00 pm, with overtime as needed. • Compensation: $50,000 - $70,000, • Excellent full time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job DescriptionSalary: Founded in 1919, Holt Construction is celebrating over 100 years in business with our 3rd generation of Holt family leadership. Holt thrives on its reputation as a quality construction company that maintains its core values and family atmosphere while providing the best services to our clients. Our teams experience, training and backgrounds have allowed us to work within the most sensitive markets, including data centers, Class A secure buildings, airports as well as the healthcare and pharmaceutical industries for over 80 years. Many of Holts employees have been with the company for over 25 years which is a true indication of our particular core values and business approach. Our extensive project portfolio and repeat clientele are testament to our quality of work and ability to develop and maintain long-term client relationships. Holts management philosophy is to be managers of the construction process, not just overseers and recorders of the process. We pride ourselves in working with owners and all team members in a collaborative process to provide cost-effective solutions to the numerous roadblocks that may be encountered during design and construction to ensure successful project execution. Job Summary The Superintendent is responsible to plan/manage/build construction projects and oversee progress from start to completion in a timely and cost-effective manner. Provide overall leadership for on-site field administration/supervision and technical management for all construction operations, including direct supervision of foreman, subcontractors, and other construction related personnel. Key responsibilities include planning, coordinating, and executing work on time, within budget, attaining or exceeding profit goals, adhering to safety standards (company and regional) and promoting and enhancing client relationships. Essential Duties and Responsibilities • Maintain a thorough understanding of contract documents, project plans and specifications to be able to plan ahead and anticipate potential problems before they arise., • Attend and participate in project meetings, including subcontractor meetings., • Plan, coordinate, and manage jobsite logistics, in coordination with Project Manager., • Coordinate project mobilization, demobilization and equipment needs with accounting., • Attend and Participate in Project Walk-throughs with Design team to address specific issues and communicate discussion/ resolution to PM for record., • Prepare and submit Superintendents Daily Reports, toolbox talks and distribute appropriately., • Manage schedules, including preparation of two-week look ahead and any other applicable schedules. Ensure all activities take place on or ahead of scheduled dates. Review weekly with PM / noting deliveries, long lead items, critical work, inspections, and any impacts affecting progress., • Oversee Holt labor and track project requirements for needed workforce, coordinating with PM for proper phase codes and available funds., • Forecast deficiencies and schedule impacts; record and address subcontractors missing milestone date deliverables and scheduled path work. Communicate schedule status, updates and changes to Project Team and Trade Contractors., • Coordinate third party site testing, and inspections with required entities to facilitate schedule progress. Maintain inspection records., • Enforce site safety plans while adhering to laws, and OSHA operating industry standards, as well as regional best practices., • Maintain a clean, safe site, with all required OSHA/ regulatory documents on hand for reference., • Conduct site safety orientation for all subcontractors and visitors., • Communicate quality standards to each subcontractor and vendor regarding contract requirements and general industry best practices., • Communicate with owners and architects/engineers in connection with field issues. Investigate and resolve issues as they arise. Escalate issues, if necessary, for prompt resolution., • Review and understand all subcontractor scopes of work and corresponding milestones for reference, coordination, and adherence. Advise PM of concerns for missing scope., • Identify Possible Changes in work requested in field and/or inconsistencies with documentation that may generate RFI and/or changes in cost of work to PM for address of RFI/ change order procedures., • Review approved submittals, RFI responses and sketches to ensure all materials and work are done in accordance with issued documents. Coordinate work / revisions with on-site trades., • Ensure all proper documentation is maintained in the project specific folders for easy reference and record keeping., • Create or ensure a photo journal is updated throughout a project. Photos must be taken starting with existing conditions for the space and all areas to be traveled or utilized during project (prior to the start of any work), as well as daily photos taken throughout the project duration., • Coordinate Close Out Documentation with PM to ensure Punchlist, Inspections/ Approvals, Trainings, Attic Stock, As-builts, etc. are addressed as designated per Contract and the Holt Closeout Checklist, • Maintain daily reports and documentation using BuildSpace and/or Procore., • Other duties as assigned. Supervisory responsibilities • Ensure all individuals on-site follow and adhere to the site safety plan., • Direct day-to-day on-site supervision of field labor force, Holt, and Subcontractor., • Communicate effectively and in a professional manner with Holt internal team, customer/project representatives, AOR/EOR or any other agency or jurisdiction to ensure the efficient operation of the assigned project., • Mentor supporting staff to assist in their progress and ability to expand their role., • Attend all corporate required trainings and classes, for new procedures or policies. Qualifications • Minimum of 5 years of field knowledge/related work experience, • Proven working experience in construction field, • Experience in Out of Ground, Site, Civil Construction, • Knowledge of building products, construction details and relevant rules, regulations, and quality standards, • Knowledge of Microsoft Office Suite (Word, Excel, and PowerPoint), • Familiarity with construction management software packages such as Microsoft Project, Primavera and/or Procore, preferred., • Ability to read and understand prints, manuals, contract requirements, and general industry best practices, • Competent in conflict and crisis management. Leadership skills, • OSHA 30 Certification, • First Aid/CPR/AED Certification, • ASHE Certification Holt Construction Corp. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status, such as race, religion, color, national origin, sex, age.

Job Description Human Resources Administrator- rx2go rx2go is seeking a dynamic Human Resources administrator to join our team and drive both administrative excellence and strategic talent acquisition. This role will be instrumental in recruiting top talent, creating seamless onboarding experiences, while maintaining strict compliance with all regulatory requirements. The ideal candidate is a detail-oriented professional with strong strategic planning capabilities and a passion for building exceptional employee experiences. Key Responsibilities Talent Acquisition & Recruitment • Lead full-cycle recruiting process, conducting interviews to assess candidates' experience, technical skills, and cultural fit, • Maintain and update job descriptions and requirements to reflect evolving business needs, • Conduct thorough reference checks and coordinate background screenings in accordance with company policies, • Design and facilitate comprehensive new employee orientation and onboarding programs, • Guide new hires through benefits enrollment, compensation structures, and company policies, • Coordinate training programs to support employee growth and development, • Ensure full compliance with all federal, state, and local HR regulations and employment laws, • Maintain accurate and confidential employee records and documentation, • Advise leadership on benefits strategy and evaluate vendor contract proposals, • Participate in or lead committees focused on wellness, training, safety, culture, and internal communications, • Support organizational planning and development initiatives, • Bachelor's degree in Human Resources, Business Administration, or related field, OR minimum 2 years of hands-on human resources experience, • Fluent Russian language skills (speaking, reading, writing) - Required, • Exceptional written and verbal communication skills with strong presentation abilities, • Proven track record in building positive interpersonal relationships and coaching employees, • Advanced proficiency with HRIS systems, Microsoft Excel, and database management, • Highly organized with strong attention to detail and ability to manage multiple priorities, • Specialized training or certification in employment law, compensation, organizational development, employee relations, safety protocols, or labor relations, • Experience in healthcare or pharmaceutical industry

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 DescriptionSalary: Founded in 1919, Holt Construction is celebrating over 100 years in business with our 3rd generation of Holt family leadership. Holt thrives on its reputation as a quality construction company that maintains its core values and family atmosphere while providing the best services to our clients. Our teams experience, training and backgrounds have allowed us to work within the most sensitive markets, including data centers, Class A secure buildings, airports as well as the healthcare and pharmaceutical industries for over 80 years. Many of Holts employees have been with the company for over 25 years which is a true indication of our particular core values and business approach. Our extensive project portfolio and repeat clientele are testament to our quality of work and ability to develop and maintain long-term client relationships. Holt s management philosophy is to be managers of the construction process, not just overseers and recorders of the process. We pride ourselves in working with owners and all team members in a collaborative process to provide cost-effective solutions to the numerous roadblocks that may be encountered during design and construction to ensure successful project execution. Job Overview The Senior Project Accountant serves a vital function in the financial reporting system of the company. Key responsibilities of this role are to assist and support the project team by reconciling and maintaining complete and accurate project accounting records. This position is highly depended upon to guide and assist junior project accountants as well as to provide timely and accurate financial information to project stakeholders including clients, subcontractors, vendors, the project team, and management. Essential Duties and Responsibilities • Attend project kick-off meeting. Review client contract for all pertinent financial information and note items, as required, • Attend monthly accounting staff meetings. Complete all duties in compliance with the month-end schedule, • Work on site with project management team (conditions permitting), • Prepare monthly requisition for Project Managers review. This includes all costs for the month, subcontractor invoices, insurance, and all applicable taxes, • Obtain the contract SOV and budget for review with Estimating and Project Management to properly assign phase codes and enter original budget into the accounting system, • Set up appropriate billing template for client billings, use the industry standard AIA format or client specific format when warranted, • Review monthly and reconcile as required:, • Owner change order requests, as prepared by project management. Update, and post as required, • Subcontracts and subcontractor change orders and submissions. Verify established billing rates for all subs, • Confirm receipt of all invoices by reviewing statements and inquire with subcontractors for any missing invoices, prior to months close, • Check invoicing forms and subcontractor progress for payment of all invoices. Follow up with client regarding project billings and payment status. Document delinquent receivable statuses weekly, • Make sure all insurance, sales and use tax rates are current and accurately reflected on all invoices for client, subcontractors, and vendors, • Compare cost and billings to date to ensure job is billed timely and properly. Identify and report any other variances to project management and accounting teams, • Work closely with Project Management to assist with the following:, • Update and balance all cost reports for financial projection and status reports monthly, • Review budget adjustments before posting, • Track budget and allowance expenditures, • Close-out procedures. Ensure that all costs have been received, processed, and included in the final billing, • Review all, • Alert Project Management and Accounting Teams as follows:, • Any instances that impede project billings, • Any unaddressed, unresolved change orders both subcontractor and client related, • Any instances that prevent close out documentation from being obtained, • Any issues that may hinder the close-out process, • Follow up with client regarding project billings and payment status. Document delinquent receivable statuses weekly, • Respond to project vendors requesting payment status, • Mentor, train and manage the day-to-day activities of Junior Project Accountants, • Interface with Owner/Owners Representative and be able to answer questions about submitted Payment Applications, • Set up the Project Specific Accounting Calendar and assist the team in maintaining deadlines, • Stay current on industry standards for project accounting, • Other duties as assigned Qualifications • Experienced with Accounting software. Viewpoint/Vista, Procore or Textura a plus, • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), • Excellent verbal and written communication skills, • Excellent organizational and time management skills, • Strong interpersonal skills to communicate with multiple participants, at all levels, involved with a construction project (i.e., clients, subcontractors, project team), • Ability to work independently and in a team environment, • Ability to supervise, direct and mentor junior employees. Supervisory experience a plus, • Ability to work on several projects simultaneously, meet critical deadlines, and prioritize assignments accordingly Holt Construction Corp. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status, such as race, religion, color, national origin, sex, age.