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Medical Science Liaison, Immunology (Northeast territory) Hybrid- in Clifton, NJ Company Profile: Global Pharmaceutical company that has 8 commercial products in Critical Care, Immunology and Hematology. What You Can Expect To Be Doing • Responsibility in the management of field-based medical activity within the company portfolio., • Provide medical/scientific expertise in the provision of educational programs and responding to medical information requests, as well as support to global and commercial functions within the organization via effective scientific exchange., • Be responsible for establishing and fostering professional relationships with key opinion leaders and ensuring access to current medical and scientific information on company products and therapeutic areas of interest., • Support the Associate Director, Scientific and Medical Affairs – Immunology in the day-to-day management of Medical Affairs activities, • Respond to Medical Information Requests (MIRs) from physicians, nurses, pharmacists, and patients; track all information requests and responses and report monthly scientific exchange activity according to company policy and requirements, • Collaborate and contribute to the design and development of medical/scientific presentation materials, training, and educational programs, • Patient and patient advocate educational programs; Clinician-directed educational programs (physicians, nurses, and pharmacists); In-services or educational program for homecare, hospitals and other partners; Initial and ongoing internal training for new employees, • Ensure adherence to budget and operational accountability for assigned functions, • Ensure compliance of Medical Affairs activities, • Develop strategies, tactics, and relationships with Key Opinion Leaders (KOLs) to accommodate academic, clinical, and scientific support for advisory boards, congresses, conventions, symposia, etc., • Review promotional and educational materials for medical and scientific accuracy as requested, • Assist in development and implementation of Advisory Board and Speaker Bureau meetings, • Assist in obtaining regional medical/scientific marketplace intelligence What you will bring to the table: • PharmD from credentialed academic institution, • Must be onsite at HQ when not traveling, • Ability to travel 40%-60% for field-based activities and attendance at clinical meetings and symposia. If you would like to learn more about this great opportunity, please reach out at #IND1

Who we are: Octapharma USA, an American subsidiary of Octapharma AG, is located in Paramus, New Jersey. Octapharma is one of the largest human protein product manufacturers in the world. Family-owned since being established in 1983, Octapharma is a global healthcare company headquartered in Lachen, Switzerland. Our products are available in 118 countries and reach hundreds of thousands of patients every year. We are an entrepreneurial company with a high-energy, fast-paced work environment. Our focus is on delivering lifesaving products to patients who rely on our therapies to treat rare diseases and other bleeding and immune disorders. Here, every employee, no matter the department or role, is highly valued and an integral part of our success, which has resulted in year-over-year growth and expansion. The power of our combined efforts and commitment as a team is what makes this all possible. By truly listening and responding to one another, we work together to reach a common goal and create an environment that inspires excellence. When you walk in our doors each day, you’ll be among a friendly group of people who respect your strengths, appreciate your interests, and support your success. We are a family. And we have our long-term employees to show for our wonderful culture and environment. Position Summary: Octapharma USA is searching for a Director, Scientific and Medical Affairs - Critical to join our team. The Director, Scientific & Medical Affairs- Critical Care will have accountability and responsibility in the management of field-based medical activity across the Octapharma USA Critical Care Portfolio. The position will be responsible for establishing and fostering professional relationships with key opinion leaders and ensuring access to current medical and scientific information on company products and critical care therapeutic areas of interest. The position will also provide medical/scientific expertise and support to global and commercial functions within the organization via effective scientific exchange. Requirements: • Ability to work onsite in Paramus, NJ HQ daily, • MD degree required, • Specialty within critical required, • Strong understanding of industry compliance guidelines, • 5+ years of related industry or clinical experience in area of focus, • Understanding of drug surveillance, product promotion, and the legal aspects of product information Octapharma USA is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Octapharma USA, we strive to exemplify diversity through our employees, recruitment efforts, and the communities we serve. While promoting equity among our employees and colleagues, we encourage open dialogue with respect for each other’s point of view. In an inclusive culture, we can foster a sense of belonging. Diversity, equity, inclusivity, and belonging are essential for the success of Octapharma USA. While Octapharma USA does not require a vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Octapharma USA will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Octapharma USA Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $220,000.00 to $300,000.00; however, unexpected, and necessary adjustments or increases may result from Company annual salary increases, if applicable, and or fluctuations in the job market necessitating adjustments to pay ranges. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a full range of medical, financial, and/or other benefits (including 401(k) eligibility and paid time off benefits, including parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Employees may be eligible to participate in Company employee benefit programs such as health insurance, flexible spending account, paid time off, and disability plan in accordance with the terms of the applicable plans. For additional general information on the company benefits, please go to Employee Benefits. Important notice to Employment Agencies - Please Read Carefully Octapharma USA, Inc. does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Job Description Wage $21.94 Supervisory Operations Clerk Looking for a better work life balance? Join an amazing organization that puts Veteran’s first for an amazing career! Come build a rewarding hospitality career that allows you to give back to the Veteran Community! With over 78 years of serving our nation’s veterans, Veterans Canteen Service (VCS) is currently seeking leaders who want to grow with us in a fast paced environment. Major Duties: • Controls, accounts for and secures all cash stored in the canteen safe as well as all safe transactions involving petty cash, change funds, withdrawals of funds, coupon transactions, etc., • Accounts for and verifies all withdrawals and deposits of funds. Reviews all sales journals and conducts regular reconciliations of all accounts., • Preparation of merchandise, food or supply purchases orders; verifying invoices; and maintaining accurate records of merchandise, food and supplies in-stock inventory., • Maintaining facilities appearance, merchandise/food displays and presentation; stocking and restocking shelves; confirming basic stock list (BSL) status; reporting unexplained losses/shortages of cash, funds or assets., • Providing floor coverage as necessary to maintain quality customer service; filling in for associate breaks/leave or other required circumstances., • Opens and closes the store by performing duties such as placing and removing signage, opening and closing tills, unlocking and securing the store., • Reports to General Manager. VCS offers competitive benefits, including: • Child Care Subsidy Program, • Public Transportation Benefits (Bus Pass), • Annual Cost of Living Pay Increases, • Major Medical, Dental, Vision Insurance & Life Insurance, • Vacation & Sick Leave to include 11 (paid) Federal Holidays, • Company Contribution to Retirement Savings Plan Requirements for Consideration: • Minimum of 1 year of direct food/retail supervisory experience, • Hands-on leadership with a strong focus on service and hospitality, • Proficient computer skills using Microsoft applications (Word, Excel, etc.), • Experience with POS Systems, • Minimum of 3 years customer service experience., • Exceptional verbal and written communication skills. Participation in the seasonal influenza vaccination program is required for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the seasonal influenza program is a condition of employment. It is a requirement that all HCP receive the annual seasonal influenza vaccination or obtain an exemption for medical or religious reasons.

Job Description Note: This is an independent contractor (1099) position. Stratpharma is a Swiss-based medical device company with a strong global footprint in wound care, dermatology, and scar management. We are internationally recognized as the GOLD STANDARD in post-surgical wound healing and scar therapies. All Stratpharma products are FDA-cleared and physician-dispensed, providing multiple options for patient care within the Veterans Affairs hospital system. This role focuses on developing and growing relationships within VA hospitals and affiliated care networks, while also supporting opportunities in related settings. This is a unique chance to join an expanding U.S. team, working with a high-commission compensation model and a product portfolio that is both differentiated and in demand. Responsibilities • Develop and expand sales within VA hospitals, outpatient clinics, and affiliated practices., • Build strong relationships with key clinical stakeholders including physicians, nurse practitioners, and wound care specialists., • Educate providers and staff on product use, protocols, and patient benefits., • Deliver persuasive business proposals, presentations, and product demonstrations., • Achieve and exceed individual territory revenue goals., • Maintain detailed account plans and leverage data/metrics to drive growth., • 2+ years of sales experience in wound care, dermatology, podiatry, or related healthcare fields., • Prior experience with VA hospitals, federal accounts, or government contracting strongly preferred., • Established relationships with clinical decision-makers in wound care or dermatology a plus., • Strong sales acumen with proven success in meeting/exceeding quotas., • Excellent organizational, communication, and presentation skills. Benefits of Partnering with Stratpharma • High commission potential with no earnings cap., • Exclusive, FDA-cleared products with limited direct competition., • Opportunity to be part of a growing U.S. expansion strategy., • Autonomy of a 1099 contract with the backing of a global brand. We are actively seeking independent sales representatives to cover VA hospitals across the United States. Priority markets: New York, New Jersey, Connecticut, Maine, Boston, Arizona, New Mexico, Texas, Colorado, Utah, Wyoming, Montana, Oklahoma and Hawaii Apply today to represent the leading name in wound care and scar management within the Veterans Affairs healthcare system.

Education & ExperienceBoard Certified MD or DO in Pediatrics (required); experience in critical and/or complex care preferred. Graduate degree in business, healthcare, or medical management strongly preferred. Strong knowledge of healthcare administration, financial management, and outcome impro

Lead REMS Medical Affairs activities: Serve as the Medical Affairs Contraception lead on REMS Advisory Committee, with dedicated responsibility for bridging Medical Affairs and REMS activities. The US Director of Medical Affairs is a key strategic role within the medical affairs organization and rep

The Director Of Medical Affairs Is A Key Strategic Role Within The Medical Affairs Organization And Reports Into The Global Director Of Medical Affairs (GDMA). Strategize And Plan: Create Global & Us Medical Affairs Plans, Ensuring Relevant Strategies And Plans Are Aligned With Organon Corporate And

Medical Director, US Medical Affairs, Women\u2019s Cancer. The Eisai Salary Transparency Language: The base salary range for the Medical Director, US Medical Affairs, Women\u2019s Cancer is from :217,000-284,800.

A global pharmaceutical company is hiring for a Director, Medical Affairs to provide scientific and medical leadership across its Critical Care portfolio - overseeing field-based medical activities, fostering effective relationships with key opinion leaders, and contributing to research and developm

The base salary range for the Medical Director, US Medical Affairs, Womens Cancer is from $217,000–$284,800.

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to en

Job DescriptionTitle: Human Resources (HR) Director Reports to: CEO Department: Shared Services - Human Resource Responsibilities: • Strategic HR Leadership, • Partner with senior leadership to develop and implement HR strategies aligned with business goals and organizational growth., • Lead workforce planning, succession planning, and organizational design initiatives to support the evolving needs of the industry., • Lead initiatives that foster innovation, creativity, and collaboration while strengthening the company’s employer brand through a strong culture and employee experience., • Compliance & Policy Maintenance, • Ensure compliance with all federal, state, and local labor laws as well as industry-specific standards., • Maintain and update HR policies, employee handbooks, and workplace practices to reflect current regulations and best practices., • Participate in internal and external audits to ensure HR compliance., • Oversee HR records management, including sensitive employee documentation., • Employee Relations & Engagement, • Serve as a primary resource for employee relations matters, including disputes, grievances, legal cases, disciplinary actions, offboarding, and exit interviews., • Provide guidance to managers and employees to ensure fair and consistent resolution of workplace concerns., • Drive employee engagement and diversity, equity, and inclusion initiatives., • Handle unemployment insurance (UI) claims, including response preparation, documentation, and representation as needed., • Talent Acquisition & Retention, • Oversee recruitment and selection strategies to attract and retain top talent across corporate, retail, and manufacturing roles., • Partner with hiring managers to develop strong pipelines of candidates in alignment with business needs., • Compensation, Performance Management & Development, • Serve the annual performance review cycle, including goal setting, performance appraisals, and merit increases., • Partner with Finance to manage HR budgets, salary benchmarking, and merit increase allocation., • Oversee compensation programs to ensure internal equity and market competitiveness., • Design and implement leadership development, training, and career progression programs., • Safety & Compliance, • Develop, implement, and monitor workplace health and safety programs in compliance with OSHA standards and company policies (e.g., PPE requirements)., • Conduct regular safety inspections, audits, and training programs., • Manage incident reporting, root cause analysis, and corrective actions., • Partner with management to reduce workplace hazards and foster a safety-first culture., • Prepare and submit required federal and state compliance reports (e.g., OSHA 301, EEO reporting)., • Manage the full cycle of workers’ compensation claims, including filing, follow-up, and case management, plan renewal., • Serve as liaison with insurance carriers, medical providers, and employees to ensure proper claim handling., • Track and report workers’ comp metrics and trends., • General Affairs, • Oversee administrative and facilities-related operations, including office management, supplies, and vendor coordination, to support daily business activities., • Manage commercial insurance policies and cases related to workplace incidents and liabilities, including claims management, coordination with insurance carriers for audits and claims resolution, and annual plan renewals., • Maintain accurate records of insurance policies and claims., • Coordinate event logistics and provide support for company events, as needed., • Assist with HR projects, reporting, and compliance audits as needed.Qualifications:, • Minimum of 10+ years of progressive HR experience, with at least 5 years in a managerial or leadership role., • Bachelor’s degree in Human Resources, Business Administration, Safety Management, or a related field required., • Knowledge of federal and state labor regulations, and workplace safety standards., • Strong organizational skills with the ability to manage multiple priorities and deadlines., • Ability to effectively communicate across diverse teams and with senior leadership., • High degree of confidentiality, professionalism, and discretion when handling sensitive information., • Proficiency in MS Office Suite (Excel, Word, PowerPoint) and HRIS systems., • Bilingual proficiency in Korean and English required.Preferred Qualifications:, • Proven experience in HR, including employee relations, workplace safety, compensation & benefits., • Preferably work experience in the cosmetics or manufacturing industry., • Master’s degree or HR certification (SHRM-SCP, PHR) is a plus., • Preferred OSHA certification (e.g., OSHA 10 or OSHA 30).Physical & Other Requirements, • Ability to work in a fast-paced office and manufacturing environment, with occasional visits between the Totowa (main office) and Wayne warehouse facility., • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match, • PTO Powered by JazzHR uo275JTQqW

Job DescriptionJob description Job Title: MEDICAL EXECUTIVE ASSISTANT Job Location: CLIFTON NJ Job Type: Full-Time Job Summary: We are looking for a proactive, highly organized, and trustworthy Personal Assistant to support the administration of a busy medical practice. This role requires a dynamic individual who can handle a wide variety of administrative tasks, provide personalized assistance, and maintain the smooth operation of both personal and professional affairs for the practice owner. If you have strong communication skills, exceptional attention to detail, and the ability to multitask, we encourage you to apply. The employee must be able to fill in the role of medical assistant and executive assistant. Must have medical experience and experience with direct patient care. Key Responsibilities: • Executive Support:, • Provide high-level administrative support to the practice CEO, including managing schedules, appointments, and meetings., • Coordinate travel arrangements, including booking flights, hotels, transportation, and preparing itineraries., • Prepare and organize materials and documents for meetings, presentations, and conferences., • Handle personal errands and tasks as needed (e.g., scheduling personal appointments, managing personal correspondence), mail etc, • Calendar and Time Management:, • Maintain and update the practice owners calendar, ensuring all personal and professional commitments are met on time., • Schedule and prioritize meetings, appointments, and events, ensuring the owners time is managed efficiently., • Proactively resolve scheduling conflicts and provide reminders for upcoming events or tasks., • Correspondence and Communication:, • Screen and manage phone calls, emails, and other communications on behalf of the practice owner., • Draft, proofread, and send emails, letters, and other forms of correspondence., • Maintain confidential communication, both personal and business-related., • Office and Administrative Tasks:, • Assist in managing medical practice-related administrative tasks., • Prepare, review, and file documents for the owners review, including financial reports and medical practice records., • Organize and maintain files, both digital and paper, to ensure important documents are accessible and well-organized., • Special Projects:, • Assist with various ongoing projects, both for the practice and the practice owners personal business interests., • Research and compile information as needed for decision-making or business planning., • Assist with event planning, including practice-related events, conferences, or personal engagements., • Relationship Management:, • Cultivate and maintain positive relationships with clients, staff, and other external parties., • Act as the point of contact between the practice owner, ceo and patients, vendors, contractors, and other stakeholders., • Help the practice owner navigate and prioritize interpersonal relationships for both business and personal interests., • Confidentiality and Discretion:, • Maintain a high level of confidentiality and professionalism when handling sensitive information, both for the practice and personal matters., • Adhere to HIPAA regulations and other confidentiality guidelines when handling patient-related or practice-related documents., • Attend Marketing events to help educate patients and the community on our services, • Fill in for medical assistants who call out, • Attend clinic office hours with the physician, to perform medical assistant duties and also translateQualifications:, • High school diploma or equivalent; Associates degree or higher preferred., • MUST have 5 years of direct patient care experience with hands on experience. MUST have 5 years proven experience as a nurse assistant, medical assistant, or administrative assistant in a healthcare setting, • MUST be bilingual, • MUST speak MEDICAL Spanish and be fluent in Spanish, • Proven experience as a personal assistant, medical assistant, nurse, executive assistant, or administrative assistant, in a healthcare setting., • Strong organizational skills with the ability to prioritize tasks and meet deadlines., • Excellent written and verbal communication skills in both English and Spanish, • Proficiency in Microsoft Office Suite, Google Workspace, and mandatory experience with medical management software (e.g., EHR systems)., • Strong problem-solving abilities and a high level of initiative., • Exceptional interpersonal skills and the ability to work effectively with diverse individuals., • Ability to work independently and manage multiple tasks simultaneously., • MUST have 5 years Previous experience with medical terminology and direct patient carePhysical Requirements:, • Ability to sit, stand, and walk for extended periods of time., • Ability to lift up to 15 lbs.* Job Types: Full-time, Part-time Pay: $19.50 per hour Expected hours: 40 per week Schedule: • 8 hour shift, • Monday to Friday, • Weekends as neededEducation:, • Associate (Preferred)Experience:, • Medical assistant: 5 years (Required)Location:, • Clifton, NJ 07012 (Preferred)Ability to Commute:, • Clifton, NJ 07012 (Required)Ability to Relocate:, • Clifton, NJ 07012: Relocate before starting work (Required)Work Location: Hybrid remote in Clifton, NJ 07012

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 Hourly Wage $19.20 Looking for a better work-life balance? Join an amazing organization that puts Veteran’s first for an amazing career! The Veterans Canteen Service (VCS) located at the East Orange, NJ, VA Medical Center is seeking part & full-time Food Service Workers to provide quality service to our nation's veterans. Major Duties and Responsibilities: • Makes coffee, Latte, cappuccino, smoothies., • Preps food items such as breakfast sandwiches, lunch sandwiches, wraps, pancakes, burritos and many more., • Cleans work areas, equipment, utensils, dishes, and silverware., • Stores food in designated containers and storage areas to prevent spoilage., • Prepares a variety of foods according to customers' orders or supervisors' instructions, following approved procedures., • Will be subjected to hot and cold temperatures. VCS offers competitive benefits, including: • Child Care Subsidy Program, • Public Transportation Benefits (Bus Pass), • Annual Cost of Living Pay Increases, • Major Medical, Dental, Vision Insurance & Life Insurance, • Vacation & Sick Leave to include 11 (paid) Federal Holidays, • Company Contribution to Retirement Savings Plan Requirements: • Excellent customer service skills, • Ability to read and interpret instructions and perform basic arithmetic used in food preparation, • Minimum of one (1) year experience in the food service industry, • Requires constant standing, walking, and frequent bending., • Must be able to lift or move objects weighing up to 40 pounds unassisted. Participation in the seasonal influenza vaccination program is required for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the seasonal influenza program is a condition of employment. It is a requirement that all HCP receive the annual seasonal influenza vaccination or obtain an exemption for medical or religious reasons.

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. This would be a full-time role, working remotely. Responsibilities: • Provide consulting and advisory services for complex regulatory issues or projects., • Author and maintain documentation as required to sustain regulatory compliance., • Provide senior technical review for complex regulatory projects., • Provide cross-functional team leadership and management of multiple stakeholders across diverse projects, • Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports., • Participate in project teams and provide expertise on related regulatory matters., • Clearly and accurately conveys information to peers, supervisors, and other stakeholders., • Participates in in implementation of new/updated operational strategies to comply with new/updated policies and recommendations., • Identifies new/updated policies and recommendations and may provide professional opinions on impact of regulatory changes to MMS and Clients (from the desk of, blogs, webinars, etc.).Requirements:, • College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred., • Minimum of 10 years experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (FDA)., • Expert knowledge of regulatory principles and concepts., • Reputation as experienced leader with evidence of sustained performance and accomplishments., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process. Powered by JazzHR 0oCgNDjfaC

Job Description The position will be hybrid requiring three days per week in the office (Tues, Wed and Thurs) at our Nutley location. The position will be covering for someone on leave for 6 months. Knowledge/Skills Required • Advanced bioscience degree required (PharmD preferred), • Oncology experience preferred, • Advanced knowledge of US regulatory standards related to pharmaceutical manufacturers’ communications and dissemination of medical information, • Excellent verbal and written skills, with experience in medical writing, • Superior literature database search skills, • Minimum of 1-3 years of experience in pharmaceutical industry-based medical information or related discipline The Medical Information Specialist is responsible for meeting the medical information needs of external customers and internal business partners as it relates to the company’s products. He/she will contribute to the development of high-quality Medical Information deliverables within the team and will be a visible member of the department by collaborating cross-functionally to meet Medical Affairs objectives. This includes but is not limited to: • Utilize clinical and scientific expertise to respond to medical information inquiries from health care professionals, patient/consumers, field staff, internal business partners and other customers, • Monitor scientific literature for potential adverse event reports; report findings to Product Safety within established timeframes, • Research and conduct detailed analyses of the scientific literature for marketed products, investigational compounds, competitor products/compounds, and related disease states. Contribute to communication, reporting and storage of findings, • Contribute to the development and revision of standard medical responses, AMCP dossiers, Q & A documents and other medical information resources, • Ensure medical accuracy of advertising, promotional and scientific materials as part of Copy Review Committee and Medical Review Committee, in collaboration with Medical Information Managers and Medical Directors, • Ensure the scientific information is consistent with product labeling

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 DescriptionTitle: Regulatory Affairs Supervisor Reports to: Manager, Regulatory Affairs Department: Quality Assurance/ Quality Control Responsibilities: • Assist the Manager during cGMP, Environmental, and Regulatory audits., • Assist the Manager to create and collate product master files (dossiers), drug master files (DMF)., • Generate and Review of CoCs, CoAs, CoMs, BSE documents, CMR documents, RM Certificate of Analysis, RM Safety Data Sheet, RM technical documents, RM composition breakdown, as may be required for local and international submissions., • Generate Raw Material Regulatory statement: Origin Statement, Clean List, Sephora, Ulta, Cruelty Free statement, Heavy metal statement, Impurity statement, REACHCompliant Statements, Global and regional Compliance statements, Food allergen statement, Fragrance allergen statement, Nitrosamine-free Statement, EU/Chinacompliant statement, etc. (as applicable)., • Responsible for Gluten free, organic (USDA/ Ecocert) regulatory submission and share updated regulation within team members., • Manage communication with Vendors/suppliers for RM documents and follow up on request with vendors., • Ability to use in-house and 3rd party portal to generate compliance documents, product information packets, Product / Formulary SDS, Toxicology statements, etc, as applicable., • Review formulas, ingredients, and associated documents for compliance with designated regulatory filings and proposed submissions. Notify heads of quality and R&D (or designee) regarding any discrepancies or deficiencies with filings and items intended for submissions., • Co-ordinate investigations (audit findings, etc); correspondences to regulatory audits; and registration of products and facility with agencies., • Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, TGA, Japan, Health Canada, ISO, EU, China CSAR, etc)., • Responsible for facility registrations, renewals, and document submissions to regulatory agencies under the direct supervision of the Head of Quality., • Assist the Manager during periodic regulatory reviews, regulatory updates, and annual GMP training., • Familiar with SOPs generation process, Specification controls, and Change Control program., • Familiar with quality management system (QMS) in compliance with US 21CFR 210, 211., • Maintain familiarity with changing global regulatory requirements., • Minimum of Bachelor degree (Life Sciences, Engineering, related profession)., • Experience of drug, cosmetic, or medical device regulatory is a pre-requisite., • Familiarity with FDA requirements under 21CFR 210, 211, & 820 is a pre-requisite., • Three + years industry or related experience in any combination of cosmetic, medical device, food, or pharma is required., • Previous regulatory, inspecting, auditing or manufacturing experience - a plus., • Data analysis skills - a plus., • Computer literate and effective communication skills., • Ability to lift and carry up to 10-15 pounds.Compensation & Benefits:, • Pay range: $67,000 - $72,000 per year, • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match, • PTO Powered by JazzHR CE9lUZzcQa

Job DescriptionTitle: Regulatory Affairs Specialist Reports to: Manager of Regulatory Affairs Department: Quality/ Regulatory Responsibilities: • Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits., • With the assistance of Head of R&D (or designee), create and collate product master files (dossiers), drug master files (DMF)., • Generate and Review of Product CoCs, CoAs, CoMs, BSE documents, CMR documents, RM Certificate of Analysis, Safety Data Sheet, technical documents, RM composition breakdown, as may be required for local and international submissions., • Generate Raw Material Regulatory statement: Origin Statement, Cruelty Free statement, Heavy metal statement, Impurity statement, Food allergen statement, Fragrance allergen statement, Nitrosamine-free Statement., • Review Customer “No-No List, Special Store Prohibited List, Prop 65, REACH-Compliant Statements, Global and regional Compliance statements, EU/China-compliant statement, etc. (as applicable)., • Co-ordinate investigations (audit findings, etc); correspondences to regulatory audits; and registration of products and facility with agencies., • Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, ISO 13485:2003)., • Responsible for facility registrations, renewals, and document submissions to regulatory agencies (eg Drug and Cosmetic listings, etc), under the direct supervision of the Head of Quality/Regulatory., • Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training., • Familiar with SOPs generation process, Specification controls, and Change Control program., • Familiar with quality management system (QMS) in compliance with 21CFR 210, 211, and 820; and key elements of ISO 13485:2003., • Maintain familiarity with changing global regulatory requirements., • Minimum of Bachelor degree (Life Sciences, Engineering, related profession)., • Experience of drug, cosmetic, medical device regulatory process is a pre-requisite., • Familiarity with FDA requirements under 21CFR 210, 211, & 820 is a pre-requisite., • Two+ years industry or related experience in any combination of cosmetic, medical device, food, or pharma is required., • Previous regulatory, inspecting, auditing or manufacturing experience - a plus., • Data analysis skills - a plus., • Computer literate and effective communication skills., • Pay range: $60,000 - $65,000 per year, • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match, • PTO Powered by JazzHR Bnx5PV2JZt

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