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Design Space InPharmatics, a leading international pharmaceutical consulting organization, is seeking an experienced Regulatory Medical Writer to support NDA submission programs for our growing portfolio of drug development clients. We are looking for a consultant with demonstrated expertise authoring and compiling FDA New Drug Application (NDA) submissions, specifically NDA Module 2 and Module 5 content in CTD/eCTD format. The ideal candidate will bring strong experience in clinical regulatory writing, integrated summaries, clinical study report development, and NDA submission strategy across small molecule and/or biologic drug products. This is a high-impact consulting engagement offering flexibility, and meaningful work at the forefront of regulatory drug development. Role and Responsibilities In this high-impact consulting role, the Regulatory Medical Writer will provide expert-level authoring and regulatory documentation support across a range of FDA NDA submission programs. Working remotely within a collaborative consulting team, the successful candidate will: • Author, edit, and compile NDA Module 2 clinical summaries and overviews, including Clinical Overview (Section 2.5), Clinical Summary (Section 2.7), Benefit-risk assessments and Integrated summaries of safety and efficacy., • Prepare and/or manage NDA Module 5 clinical documentation, including Clinical study reports (CSRs), Protocols and protocol amendments, Statistical analysis plans (SAPs), Case report tabulations, and listings coordination., • Ensure all documents comply with FDA guidance requirements, ICH CTD/eCTD standards, Good Clinical Practice (GCP), and internal quality and style standards., • Participate in submission planning, document gap assessments, and submission readiness reviews., • Support the preparation of responses to FDA information requests and review comments., • Coordinate timelines and deliverables to support NDA submission milestones., • Collaborate cross-functionally with clinical development teams, biostatistics, data management, pharmacovigilance, regulatory affairs, and medical affairs., • Function as a trusted regulatory writing subject matter expert within client project teams and CMO relationships., • Proactively flag gaps or risks relative to FDA expectations or industry best practices. Qualifications and Education Requirements • Advanced degree preferred (PharmD, PhD, MD, MS, or equivalent scientific discipline), Minimum 8–10 years of pharmaceutical or biotechnology regulatory writing experience., • Direct, hands-on experience authoring FDA NDA Module 2 and Module 5 content., • Strong knowledge of FDA NDA submission requirements, ICH E3 and CTD/eCTD structure, clinical trial documentation standards, and drug development processes. Preferred Skills • Experience with small molecule drug development programs., • Demonstrated expertise preparing integrated summaries of safety (ISS) and integrated summaries of efficacy (ISE)., • Familiarity with publishing systems and eCTD submission platforms., • Prior interaction with FDA review teams or support during regulatory agency meetings., • Consulting experience supporting multiple sponsors or parallel drug development programs., • Excellent scientific writing, editing, and data interpretation skills., • Ability to work independently and manage multiple deliverables in a fast-paced consulting environment. Additional Notes • Candidates who bring experience across both small molecule and biologic programs, or who have supported multiple NDA submissions across different therapeutic areas, will be especially well regarded. The responsibilities outlined in this position represent a general summary of the consulting role and are not intended to be all-inclusive. DSI reserves the right to amend this description as client program needs to evolve., • This is an excellent opportunity for a seasoned regulatory writing professional seeking to apply their expertise within a dynamic, market-leading consulting organization at the forefront of pharmaceutical regulatory strategy and drug development services., • This is a fully remote, independent consultant role. Consultants are engaged on a project basis and may be assigned to one or multiple concurrent engagements. Hours are not fixed and will fluctuate based on project requirements, milestones, and client needs., • All applications are reviewed by our human hiring team. No automated screening or AI-based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration.

The Corporate Counsel is responsible for managing various legal matters pertaining to Terumo Americas Holding, Inc. and certain of its subsidiaries and affiliates (collectively “TAH”), including clinical and medical affairs, commercial operations, contracting, healthcare compliance, employment law, corporate governance and intellectual property matters. Additionally, the Corporate Counsel will work with VP & Deputy General Counsel – Legal to develop long and short-term plans pertaining to legal matters to best manage TAH’s legal activities and minimize the risk to the business. Provide legal support and advice to TAH management and various internal business functions. Provides business with effective advice on company strategies and their implementation while ensuring adherence to state, federal, and international laws and regulations. Oversees reviewing, drafting, and negotiation of various commercial agreements. Will be responsible for protecting TAH against legal and compliance risks. Job Details: • Prepares, drafts, reviews, negotiates and modifies a wide variety of commercial contracts and other documents with legal significance, including but not limited to clinical trial agreements, sales agreements, GPOs, procurement agreements, consulting agreements, business development agreements, clinical affairs agreements, and confidentiality agreements., • Identifies, researches and provides advice on complex legal and commercial compliance issues and develops resolutions to those issues., • Exercises considerable judgment in identification of risks and proposals of alternative solutions to mitigate risks involved in potential transactions., • Assist in the identification, delivery of advice on and resolution of highly complex legal and commercial compliance issues., • Assists on strategic transactions and other mission critical initiatives., • Identifies the need for, initiates and develops language for the implementation of legal or commercial compliance policies., • Assists in the preparation and maintenance of corporate records for various TAH entities worldwide., • Stays current on developments in applicable laws, regulations and industry codes of ethics and practices., • Oversee the selection, management and evaluation of all outside counsel., • Interprets laws, rulings and regulations for the company and recommends appropriate changes or actions., • Maintain compliance with all Quality System requirements by maintaining a strong working knowledge of assigned training requirements. Fully adhere to all applicable government regulations, international guidelines and Terumo’s policies at all times. Establish and promote a work environment amongst co-workers that supports compliance with the Quality System and Terumo’s policies., • Perform other job-related duties as assigned. Position Requirements: • Knowledge, Skills and Abilities (KSAs), • Demonstrate understanding of market challenges, organizational scale requirements, and the legal processes needed to support a rapidly growing company., • Strong communication skills, including written communications, presentations, rapport building, negotiating and influencing skills., • Excellent team leadership and collaboration skills with internal clients, external collaborators or partners, and other stakeholders., • Adept at the leadership and management of change with the ability to diagnose and solve problems, articulate a plan, and implement solutions., • Basic understanding of FDA Regulations, the Sarbanes-Oxley Act, and knowledge of U.S. health care compliance and global anti-corruption and anti-bribery laws and regulations (e.g., FCPA, Stark and Anti-Kickback)., • Extensive knowledge and experience in clinical and medical affairs, contract law, health care law, intellectual property law including patent law and licensing, and employment law., • Broad knowledge of relevant laws and regulations, analytical ability, business savvy, and a balance of legal, compliance and operational experience. This team player must relate well to all levels of employees and external stakeholders., • Knowledge of Word Processing, Spreadsheet, Database, and Internet software., • Background Experiences, • Requires Juris Doctor from an accredited law school. Member of the bar in good standing; admission to New Jersey state bar preferred., • Minimum 6 years’ of legal experience in a relevant law firm or corporate setting., • Medical device, pharmaceutical, life science, or other healthcare related experience preferred., • Experience managing and dealing effectively with a broad range of legal matters across the spectrum of clinical and medical affairs, commercial contracting, employment law, compliance programs, intellectual property, mergers and acquisitions, product liability and any and all laws and statutes related to the healthcare industry., • Experience dealing with international organizations and the broad issues encountered while dealing with differences of opinion and approach to international business issues.

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: _ The Senior Manager, Clinical Operations is responsible for the operational planning, execution, and oversight of clinical trials supporting the company's clinical development programs. This role may serve as the Lead Clinical Trial Manager or function as a key operational contributor within a larger program team. The position ensures clinical trials are conducted in compliance with applicable regulatory requirements, ICH-GCP guidelines, company Standard Operating Procedures (SOPs), and study protocol. The Senior Manager collaborates cross-functionally with internal and external stakeholders and external service providers to ensure the successful delivery of clinical trials with respect to quality, timelines, and budget. The Senior Manager may have direct reports, and will provide leadership, mentorship, and operational guidance to junior team members. The Senior Manager, Clinical Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. . ESSENTIAL FUNCTIONS Primary duties/responsibilities: Clinical Trial Management Lead or support the operational execution of Phase I-IV clinical trials, depending on study complexity and program needs. Serve as Lead Clinical Trial Manager for assigned studies, with responsibility for study timelines, operational strategy, and study deliverables. Contribute to the development planning and operational feasibility assessments. Develop and manage key study documents including: Clinical Trial Management Plans Study timelines and milestone tracking Vendor scopes of work and operational budgets Oversee study start-up, conduct, and close-out activities. Clinical CRO and Service Provider Oversight Provide operational oversight of Clinical CROs and other operational service providers to ensure delivery of services consistent with contracted agreements and study requirements. Participate in service provider selection, RFP development, and contract review. Monitor service provider performance, study metrics, and key performance indicators to ensure study quality, and timelines are maintained. Cross-Functional Collaboration Partners with internal functions including Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Writing, Project Management, Clinical Supply, and Quality Assurance. Ensure alignment of operational study and overall program strategy and development timelines. Study Oversight and Compliance Ensure clinical trials are conducted in accordance with: ICH-GCP guidelines Applicable global regulatory requirements Company policies and standard operating procedures Support inspection readiness and contribute to audit preparations and follow-up activities. Identify operational risks and develop mitigation and contingency strategies. Site and Study Support Provide oversight of site identification, feasibility, selection, and activation activities. Review monitoring reports and key study metrics to ensure appropriate study oversight. Support resolution of site issues, enrollment challenges, and protocol implementation questions. Budget and Timeline Management Contribute to study budget development and ongoing financial oversight. Monitor study progress against timelines, key milestones, and performance metrics. Identify potential risks to study execution and implement corrective actions as needed. Team Leadership and People Management May manage and develop direct reports. Provide mentorship, guidance, and oversight of junior Clinical Operations staff. Support performance management, professional development, and training of team members. Foster a collaborative and high-performing clinical operations team environment. Documentation and Reporting Contributes to preparation of study management plans, service provider oversight documentation, and operational reports. Provides regular updates on study status, risks, and mitigation strategies to Clinical Operations Leadership. Ensure study documentation is maintained in accordance with company requirements and is inspection ready. Performs other tasks and assignments as needed and specified by management. KNOWLEDGE/SKILLS/ABILITIES REQUIRED • Minimum level of education and years of relevant work experience. Bachelor's degree in a scientific discipline and a minimum of 7 years of progressively responsible US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO or related environment OR equivalent education and/or experience. • Special knowledge or skills needed and/or licenses or certificates required. Strong knowledge of ICH-GCP guidelines and global clinical trial regulations. Demonstrated ability to lead clinical trial operations and cross-functional teams. Demonstrated leadership ability and experience managing, coaching and mentoring direct reports (if managing people). Strong project management and organizational skills. Experience with risk-based quality management and vendor oversight models. Analytical thinker with excellent communication, collaboration, and problem-solving abilities. Ability to balance strategic oversight with operational execution. Passion in advancing therapies for patients with unmet medical need. Experience with Microsoft Office Suite. *Special knowledge or skills and/or licenses or certificates preferred. Experience executing clinical trials in rare disease populations Experience working with global centers of excellence and highly specialized investigative sites. Experience with strategic CRO partnership models and formal service provider oversight documentation Working knowledge of risk-based quality management frameworks Familiarity with inspection readiness frameworks, trial master file quality expectations, and audit responses. • Travel requirements Approximately 20% Expected Base Salary Range: $136,600 - $171,900. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans. EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. _

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: _ The Senior Manager, Clinical Pharmacology conducts pharmacokinetic/toxicokinetic studies to support preclinical and clinical development of novel therapies and life cycle management. The incumbent collaborates with discovery and development teams, as well as colleagues in clinical pharmacology and DMPK team to implement clinical pharmacology strategies for drug development. This role involves hands-on executing non-compartmental analysis (NCA); managing and maintaining related software and data archiving packages; reviewing, maintaining, and generating related standard operation procedures (SOPs) and working instructions; strong cross-functional collaboration with internal and external partners, including Discovery Research, Clinical Development and Clinical Operations, Medical Writing, and Regulatory Affairs to advance therapeutic candidate in an efficient manner. This individual may also be responsible for operational and project leadership activities as assigned by the manager. The Senior Manager, Clinical Pharmacology supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. ESSENTIAL FUNCTIONS Primary duties/responsibilities: • Conducts pharmacokinetics and toxicokinetics analysis to support preclinical and clinical drug discovery and development., • Prepares study protocols, scientific reports, and presentations related to preclinical and clinical studies., • Assists in developing clinical study and regulatory documents, e.g. protocols, analysis plans, INDs and NDAs., • Generates standard operating procedures (SOP) and work instructions, • Complies with SOPs and all relevant regulatory guideline., • Manages PK (and PD) analysis software packages (e.g. Phoenix WonNonlin, PK Submit, and relevant packages) and data archiving system (e.g. DS integral)., • May provide direct support for the operational and project leadership activities as assigned by the manager., • Evaluates and selects Contract Research Organizations (CROs) and actively oversees outsourced PK, PK/PD, and exposure-response analyses. KNOWLEDGE/SKILLS/ABILITIES REQUIRED • Minimum level of education and years of relevant work experience., • PhD/PharmD in a relevant scientific discipline with a minimum of 5 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education. • Special knowledge or skills needed and/or licenses or certificates required., • Hands-on experience with non-compartmental (NCA) PK analysis to support preclinical and clinical pharmacokinetic/toxicokinetic studies., • Proficiency with PK analysis software packages (such as Phoenix WinNonlin)., • Demonstrated experience in writing study reports and regulatory documents., • Excellent planning, organization and time management skills, including the ability to support and prioritize multiple projects., • Excellent verbal and written communication and skills with the ability to influence without direct authority., • Ability to work independently and collaboratively as required, in a fast-paced, matrixed team environment consisting of internal and external team members., • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines., • Excellent management and interpersonal skills. *Special knowledge or skills and/or licenses or certificates preferred. • Drug metabolism and bioanalysis experience preferred., • Experiences in R, DS Integral, and NONMEM are highly preferred., • Data-handling skills and solid understanding of clinical database structures, such as SDTM and ADaM • Travel requirements, • 0-10% Expected Base Salary Range: $127,600 - $160,600. The base salary offered will be contingent on assessment of the candidate's education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans. #LI-NM1 EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. _

Job Description Job Description Date 2026 Location 1200 Airport Road, North Brunswick NJ Title Senior Manager, R&D Department Research & Development Reports to VP, Research & Development FLSA (Exempt or Non-Exempt Exempt Role Overview The Senior Manager, R&D will lead multiple product development programs through the research, scale-up, and commercialization process while ensuring adherence to cGMPs, SOPs, FDA requirements, and customer expectations. This individual will provide technical and managerial leadership to the R&D team, oversee development priorities, manage complex projects, and partner closely with Production, Quality, Regulatory, Procurement, and Commercial teams. The Senior Manager, R&D will play a critical role in building and executing integrated development plans, improving department capabilities, mentoring team members, and supporting the company’s strategic growth and innovation initiatives. The duties and responsibilities described are not limited to those outlined and are not intended to be a comprehensive list of all activities, functions, or responsibilities required of the position. Additional duties and responsibilities may be assigned as required. This position requires travel for customer visits and trade shows, both within the United States and internationally, as needed to support business objectives. Areas of Responsibility Leadership & Strategy • Lead and manage the R&D function for new product development, reformulations, and line extensions., • Supervise, coach, and develop a team of formulation scientists, chemists, and R&D associates., • Establish department priorities, allocate resources, and ensure project timelines are achieved., • Collaborate with senior leadership to define product strategy, innovation pipeline, and technical direction., • Drive continuous improvement initiatives related to product development, manufacturing processes, and departmental efficiency., • Serve as the technical lead and subject matter expert for formulation and process development activities. Product Development & Commercialization • Oversee development and commercialization of nutraceutical products including capsules, tablets (monolayer, bilayer, trilayer), beadlets, powders, stick packs, and other specialty dosage forms., • Develop robust formulations and scalable manufacturing processes for dietary supplements and nutraceutical products., • Research and evaluate new ingredients, technologies, excipients, delivery systems, and product claims., • Lead feasibility assessments, prototype development, and technical evaluations for new business opportunities., • Design and direct laboratory experiments, pilot studies, and process optimization activities., • Recommend alternative ingredients and/or process improvements to enhance product quality, manufacturability, cost, and efficiency., • Scale up pre-exhibit and exhibit batches to commercial manufacturing and lead technology transfer from R&D to Production., • Coordinate manufacturing start-up activities and provide floor support during scale-up and initial production runs. Regulatory, Compliance & Documentation • Ensure all product development activities comply with applicable SOPs, FDA regulations, dietary supplement regulations, and Current Good Manufacturing Practices (cGMPs)., • Create, review, and approve SOPs, technical documents, formulas, specifications, validation protocols, and product development reports., • Review batch records, process characterization studies, validation reports, deviations, CAPAs, and investigation reports., • Prepare and review technical briefs, ingredient specifications, risk assessments, and customer-facing development summaries., • Support internal and external audits, customer visits, and regulatory inspections., • Maintain accurate and complete project documentation in accordance with company standards. Cross-Functional Collaboration • Partner closely with Production, Quality Assurance, Quality Control, Regulatory Affairs, Procurement, Supply Chain, Sales, and Marketing teams., • Present technical findings, risks, recommendations, and project status updates to cross-functional teams and leadership., • Identify and proactively communicate development risks, technical issues, and timeline impacts., • Work with vendors and suppliers to identify and qualify new raw materials and technologies., • Support business development and customer meetings by providing technical expertise and formulation recommendations. Additional Responsibilities • Monitor industry trends, emerging ingredients, formulation technologies, and competitive products., • Develop and manage project timelines, budgets, and department metrics., • Assist with annual planning, capital requests, and staffing needs for the R&D department., • Perform other duties and special projects as assigned. Other Responsibilities Including Safety: • Comply with all job-related safety and other training requirements. Requirements Education & Qualification: • Master’s degree in Pharmaceutical Sciences, Chemistry, Food Science, Chemical Engineering, or a related scientific discipline required., • OR a combination of education and experience equivalent to the above requirements., • 8–12+ years of progressive experience in product development, formulation, and commercialization within the nutraceutical, dietary supplement, pharmaceutical, or CDMO industry., • Minimum 3–5 years of leadership or people management experience., • Strong experience with tablets, capsules, powders, beadlets, and related dosage forms., • Proven experience in scaling products from laboratory through commercial manufacturing., • Experience working in a fast-paced contract manufacturing or CDMO environment strongly preferred. Certifications, Licenses, Credentials: • N/A Skills & Ability • Thorough understanding of cGMPs, FDA regulations, dietary supplement regulations, and product development processes., • Strong technical knowledge of formulation science, process development, scale-up, and manufacturing., • Excellent leadership, coaching, and project management skills., • Strong analytical and problem-solving abilities with the ability to interpret complex technical data., • Excellent written and verbal communication skills., • Ability to manage multiple projects simultaneously and meet aggressive timelines., • Strong organizational and cross-functional collaboration skills., • High level of ethics, integrity, professionalism, and confidentiality., • Proficient in Microsoft Office and ERP/document management systems.Able to maintain a professional and positive attitude., • Able to maintain confidentiality and possess a high level of ethics and integrity. Physical Requirements (lifting, etc.): • The employee is frequently required to sit (50%), stand, and walk (50%). Uses hands to finger, handle or feel writing tools and computer keyboard. May reach with hands and arms and infrequently may lift up to 30lbs. Use desk telephone/cell phone to talk and hear or converse with other employees. Work Environment (Office, Warehouse, temperature extremes, etc.): • Primarily located in an office environment where temperatures are controlled for heat and air conditioning. Occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area including safety shoes, hair net, safety glasses, face mask, gloves, or disposable jumpsuit. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including medical, dental, vision, short- and long-term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation in the first year, which grows to 12 days starting the second year of employment. Job Description Acknowledgement I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation.

Job Description Position: Physician Assistant Reports to: Medical Director Position Overview: Physician Assistant plays a vital role in tackling obesity challenges and ensuring the highest standards of patient care. Reporting to the Medical Director, this position emphasizes evidence-based medical care, preventive medicine, and compassionate, patient-centered services. Essential Job Functions: • Obtain and review patient medical and psychosocial histories relevant to patient care., • Conduct physical examinations in line with company guidelines., • Order and review laboratory results, diagnostic procedures, and ECGs as required for optimal patient care., • Provide preventive medicine counseling, program guidance, and education on products and supplements to maximize the safety and efficacy of our program., • Adhere to prescription guidelines as per the collaborative agreement with the supervising physician., • Review patient progress and manage patient care accordingly., • Maintain all required documentation for patient care and medication management in the EMR, according to company standards., • Facilitate referrals to other healthcare professionals and medical facilities, consulting as needed to ensure continuity of care., • Conduct follow-up calls to patients to discuss progress and address concerns., • Demonstrate personal learning and resourcefulness, seeking opportunities to enhance clinical knowledge and stay current on new healthcare industry developments. Non-Essential Job Functions: • Review Weight Tracker Report, Slipping Patients’ Report, assigned Key Performance Indicators (KPI), and other relevant clinical reports weekly to provide oversight and guidance to clinical staff., • Serve as the company liaison for medical and clinical affairs at the location(s)., • Participate in ongoing training initiatives and act as the in-house trainer for medical staff., • Seek opportunities to improve franchise clinical operations' efficiency, effectiveness, and capacity., • Develop strategic recommendations to support patient experience improvement initiatives., • Participate in the launch of new programs, services, and products, leading change effectively among clinic staff., • Demonstrate strong project management skills and effectively develop and monitor project work plans., • Maintain a positive attitude and demonstrate the ability to work as part of a team., • Model company values of collaboration, trust, innovation, and patient care. Requirement: • Physician Assistant License (Required), • DEA Certification (Preferred), • Formal IV Training (Preferred), • Previous credentialing with major insurance carriers (Preferred), • Bilingual in Spanish (Preferred), • Knowledge of Exercise Physiology (Preferred), • Sales and marketing experience (Preferred), • Management and leadership experience (Preferred), • Experience with Hormone Replacement Therapy (Preferred) Other Skills/Abilities: • Strong motivational counseling and advising skills, • Excellent interpersonal and human relations skills, • Ability to multi-task, apply critical thinking, and deliver top-tier customer service at all levels of operation, • Exceptional oral and written communication skills, • Ability to maintain confidentiality

Job Description About Spectrum Vascular Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset. Role Description: The Director, Regulatory Affairs is responsible for leading and executing regulatory activities to support global product registrations and lifecycle compliance for the company's medical device portfolio. This role combines strategic oversight with hands-on regulatory execution, including direct authorship of complex submissions (e.g., 510(k)s), regulatory assessments, and agency interactions. This individual serves as a key regulatory lead within cross-functional teams and is accountable for ensuring that regulatory requirements are effectively translated into actionable plans and deliverables across the product lifecycle. Key Responsibilities • Serve as the regulatory lead for product development and lifecycle management, providing both strategic direction and hands-on execution of regulatory deliverables., • Author, review, and finalize regulatory submissions (e.g., 510(k), PMA, international dossiers), ensuring high-quality, technically sound, and compliant submissions., • Lead preparation and management of U.S. FDA and global regulatory submissions, including direct interaction with regulatory authorities and notified bodies., • Drive regulatory strategy development for new products, product changes, and global market expansion, while ensuring alignment with business objectives., • Act as the primary regulatory representative on cross-functional teams, influencing decisions related to product design, claims, testing, and labeling., • Evaluate and interpret regulatory requirements, guidance documents, and regulatory intelligence, translating them into actionable plans., • Provide expert regulatory input into design control, risk management (ISO 14971), clinical, and preclinical activities to support submissions and compliance., • Assess the regulatory impact of product and process changes, and define appropriate submission strategies or justification for non-submission., • Lead and support regulatory agency interactions, including pre-submissions, deficiency responses, and meeting preparation., • Ensure timely responses to regulatory inquiries and manage commitments to regulatory bodies., • Oversee and contribute to labeling and promotional material review to ensure compliance with applicable regulations and approved claims., • Provide regulatory leadership in quality system activities, including CAPAs, nonconformances, field actions, and change control., • Support and participate in audits and inspections (FDA, Notified Bodies), including preparation and response activities., • Mentor and provide guidance to junior regulatory staff, while remaining actively engaged in execution., • Contribute to the development and continuous improvement of regulatory processes, SOPs, and internal best practices. Competencies • Demonstrated ability to operate at both strategic and tactical levels, with strong execution focus, • Deep technical expertise with the ability to independently author complex regulatory submissions, • Strong analytical and problem-solving skills, with the ability to navigate ambiguous regulatory pathways, • Effective communicator with the ability to influence cross-functional stakeholders and senior leadership, • High attention to detail with a consistent focus on quality and compliance, • Ability to manage multiple priorities and adapt in a fast-paced, evolving regulatory environment, • Proven leadership capability, including mentoring and guiding team members Qualifications • Bachelor's degree (B.S. or B.A.) in Engineering, Life Sciences, or related field required, • 8–10+ years of regulatory affairs experience in an FDA-regulated industry (medical device preferred), • Demonstrated hands-on experience authoring and leading 510(k) submissions, • Strong knowledge of FDA regulations, global regulatory frameworks, and medical device requirements, • Experience interacting directly with FDA and Notified Bodies, • Solid understanding of design controls, product development, and lifecycle management, • Advanced degree preferred Work Environment: · Dynamic, interactive, fast-paced, and entrepreneurial environment · Travel – up to 25%??, additional may be required during execution of validation activities Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. Job Title: Construction Project Manager Location: Piscataway, NJ (Fully onsite) Reports to: Director of US Site Operations Compensation: The estimated salary range is $120,000 - $150,000, based on experience. Overview: GenScript is seeking a talented, detail oriented and self-driven individual to join the Operations Department, contributing to the planning, design, construction, commissioning, validation, and engineering process systems development for our facilities in Piscataway, NJ. This position is valid for at least 1-2 years with the opportunity to transition to facility manager after the construction projects are done. Job Responsibilities: Project Planning and Execution: • Develop comprehensive project plans ensuring projects proceed according to set objectives, including requirement gathering, feasibility analysis, risk assessment, and solution formulation., • Manage cost estimation for all project phases and create cost control plans., • Procurement and Contract Management., • Oversee bidding and procurement for project design, construction, and long-lead equipment., • Manage contract signing and execution with suppliers and contractors, ensuring compliance with terms, quality, and deadlines. Compliance and Regulatory Affairs: • Plan and execute government and third-party procedures to ensure project compliance with US regulations., • Plan and manage government permits applications. Project Management: • Manage technical, quality, safety, and timeline aspects of projects, ensuring timely resolution of technical issues, compliance with quality standards, and implementation of safety measures., • Coordinate with construction firms, supervisory, and contracting units to manage internal and external project relationships., • Commissioning and Validation:, • Organize factory acceptance tests, commissioning, and validation to ensure systems meet user requirements. Project Completion: • Lead the final inspection, handover, documentation review, and project settlement activities, ensuring successful project completion and handover., • Reporting and Improvement:, • Regularly report project progress, compile project reports, analyze lessons learned, and suggest improvements. Qualifications and Requirements Education and Experience: • Bachelor's degree or higher in Mechanical/Electrical, Chemical Engineering, Biomedical Engineering, or related fields., • 10+ years of experience in biopharmaceuticals with substantial project management and facility operations experience., • Hands on experience in managing construction, experience in executing projects from business requirement collection through to design, construction, commissioning, validation, and final settlement is preferred. Skills: • Strong management and reporting capabilities, clear management vision, able to handle high-pressure work environments., • Solid technical expertise combined with engineering knowledge., • Demonstrated skills in problem solving, root cause analysis with result driven thought process. Additional Considerations: • Proficient in project management software (e.g., Procore, Microsoft Project, Primavera P6)., • Familiarity with construction estimating and scheduling tools., • Understanding of US building codes, zoning laws, safety regulations, and biopharmaceutical industry standards. #LI-EB1 #GS GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology. Job Title: General Affairs Manager Location: Piscataway, NJ (Fully Onsite) Reports To: Director of US Site Operations Compensation: The estimated salary range is $100,000 - $115,000, based on experience level. Job Scope: The General Affairs Manager is responsible for site operational coordination, stakeholder engagement, and administrative strategic vendor management. This role oversees the administrative function through an Admin Supervisor while leading cross-functional initiatives and operational excellence programs at the Piscataway sites. Key Responsibilities: 1. Stakeholder Management & Corporate Hospitality • VIP Visit Coordination: Lead the planning and execution of visits for government delegations, key account clients, and global executive tours., • Define and maintain site reception standards to ensure a professional corporate environment., • Corporate Events: Oversee high-impact site events and cultural programs that align with company values.2. Strategic Vendor & Contract Management, • Commercial Negotiations: Directly lead negotiations with key service providers (e.g., hotel groups, airlines, and catering partners) to secure preferential rates and enhanced employee benefits., • Service Excellence: Establish KPIs for all major vendors and conduct regular performance reviews to ensure service quality and cost-efficiency.3. Site Operations & Lean Promotion, • Operational Excellence: Partner with the Site Director to implement Lean, 5S, and continuous improvement (CI) initiatives within the administrative and public areas of the campus., • Cross-Functional Coordination: Act as the operational bridge between General Affairs, Facilities, EHS, and other departments for site-level projects, such as space enhancements or workflow optimizations.4. Team Leadership & Governance, • Team Direction: Direct the Sr. Admin Supervisor and team to ensure the high-quality delivery of daily administrative services (travel, catering, office supplies)., • Process Standardization: Lead the development and optimization of Standard Operating Procedures (SOPs) for all GA functions to ensure operational consistency and scalability., • Financial Management: Own the departmental budget, tracking spending and implementing cost-saving measures through data-driven analysis.Core Requirements:, • Professional Experience: 4+ years in corporate administration, operations management, or project management., • Negotiation Skills: Proven ability to manage vendor relationships and lead commercial contract negotiations with measurable outcomes., • Communication: Excellent interpersonal skills; must be able to influence and coordinate across all levels of a global organization., • Education: Bachelor's degree in Business, Operations, or a related field.Preferred Skills:, • Lean Mindset: Interest or experience in applying Lean, 5S, or other continuous improvement methodologies to administrative operations., • Project Management: Demonstrated ability to manage multiple projects simultaneously with strong attention to detail. #GS #LI-EB1 GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job Description Job Summary: As a field-based medical expert, the Medical Science Liaison (MSL) supports AQST's therapeutic areas of interest, programs, and approved products by advancing scientific and medical relationships by engaging with key members of the healthcare community functioning as a conduit for scientific and clinical knowledge exchange. The MSL focuses on educating external and internal stakeholders on the science behind the safe and appropriate use of our products. The MSL supports the generation of scientific and medical knowledge and applies subject matter expertise and experience to advance company projects. This role reports to the Field Director of Medical Affairs and operates independently from Commercial in accordance with company compliance policies. This role offers growth opportunities within Medical Affairs based on performance and organizational needs. Responsibilities: • Develop and maintain a level of scientific and medical knowledge in the assigned therapeutic area(s) and/or disease state(s) related to AQST products., • Identify, develop, and effectively manage KOL relationships on a continuum of advocacy in support of company objectives while enhancing AQST's reputation as a scientifically innovative industry partner., • Accurately and compliantly interpret and disseminate balanced and factual scientific, clinical, and health economic data., • Lead efforts in identifying, cultivating, and integrating KOL contributions and insights into therapeutic areas of interest and programs of AQST. Identify opportunities for growth and generation of medical contributions in support and/or expansion of current programs and therapies., • Gather and evaluate new information as it applies to AQST products and areas of therapeutic interest., • Deliver on project support according to established objectives., • Provide support for unsolicited requests for medical information., • Support key initiatives such as continuing medical education (CME) programs and investigator-initiated research efforts., • Responsible for a defined geographic territory, managing relationships with priority KOLs across academic and community settings Qualifications: • Doctoral level degree in a medical and or scientific field required (PharmD, PhD, MD/DO, DNP, or equivalent)., • A degree in a relevant medical and/or scientific field with strong related experience may be considered., • A minimum of 3-5 years in a relevant pharmaceutical/biotechnology industry role or in healthcare is required., • Experience in allergy/immunology is highly desired with pediatric experience also helpful., • Ability to travel 60% of time, including overnights and weekends as necessary., • Solid interpersonal and communication skills with a demonstrated ability to be a relationship builder., • The ideal candidate must have character traits that promote respect, credibility, and trust throughout all interactions, outside and inside the organization., • Must be able to organize, prioritize, and work effectively and operate independently in a dynamic field-based environment., • Strong presentation and writing skills and should be results oriented and self-motivated. The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, 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. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected Base salary range: $160,000.00 to $220,000.00 USD and includes eligibility for a quarterly incentive bonus plan

MD, PhD or PharmD in Pain medicine or a closely related specialty and minimum10 years experience in pharmaceutical or biotechnology industry within medical affairs or clinical research in positions of increasing technical responsibility (minimum 3 of those years in pain therapy) REQUIRED. The Medica

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